The KEYNOTE-052 study evaluated pembrolizumab monotherapy in the first-line treatment of advanced urothelial carcinoma in patients ineligible for cisplatin-based chemotherapy. In the planned interim analysis of the first 100 patients, the objective response rate was 24%, including a complete response in 6% of patients. Fifteen percent of patients experienced stable disease as their best response. The study aims to determine the optimal PD-L1 expression cut point for predicting response to pembrolizumab.
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
Lung cancer is a leading cause of cancer death. Immunotherapy using immune checkpoint inhibitors that target proteins like PD-1 and PD-L1 has shown promise in treating lung cancer. A study presented at ASCO 2015 found that treatment with the PD-L1 inhibitor atezolizumab resulted in improved survival for NSCLC patients with higher levels of PD-L1 expression on tumor cells compared to docetaxel chemotherapy. Another study showed nivolumab, a PD-1 inhibitor, improved survival over docetaxel as a treatment for advanced non-squamous NSCLC after chemotherapy, with greater benefit seen in patients with higher PD-L1 expression levels. These results suggest PD-L1 expression can help identify
The document discusses GSK's oncology R&D strategy of maximizing survival through transformational medicines and combinations. It focuses on immuno-oncology, epigenetics, cell and gene therapy. The pipeline includes BCMA and NY-ESO-1 CAR T-cell therapies, OX40 and ICOS agonist antibodies, a TLR4 agonist, and a BET inhibitor showing early efficacy in NUT midline carcinoma. GSK's strategy involves diversifying across modalities, pursuing combination therapies, and building partnerships to sustain a long-term leadership position in oncology.
1. Lung neuroendocrine tumors (NETs) have been increasing in incidence and include typical carcinoid (TC), atypical carcinoid (AC), large-cell neuroendocrine carcinoma (LCNEC), and small-cell lung cancer (SCLC).
2. Diagnosis of lung NETs can be difficult due to non-specific symptoms and frequently involves histopathological examination. Treatment depends on tumor grade and stage.
3. For localized disease, surgery is the primary treatment. For advanced or metastatic NETs, options include somatostatin analogues, targeted therapies like everolimus, chemotherapy, and peptide receptor radionuclide therapy.
The document discusses lung cancer subtypes and molecular features that can guide treatment. It provides statistics on the distribution of histology types among lung cancer cases. It also summarizes several key studies investigating targeted therapies such as EGFR TKIs versus chemotherapy as first-line treatment for advanced non-small cell lung cancer, noting improved progression-free survival with TKIs in patients with EGFR mutations. Molecular testing is increasingly important for determining personalized treatment approaches in lung cancer.
1) Recent immunotherapy advances for advanced NSCLC include the approval of pembrolizumab as a first-line treatment for patients with PD-L1 expression ≥50% based on results from the KEYNOTE-024 trial showing improved progression-free and overall survival compared to chemotherapy.
2) The Phase III KEYNOTE-407 trial found that combining pembrolizumab with chemotherapy improved progression-free survival compared to chemotherapy alone in patients with untreated metastatic squamous NSCLC, regardless of PD-L1 expression level.
3) Combining chemotherapy with immunotherapy may enhance the immune response by increasing antigen presentation, disrupting immune evasion mechanisms, and improving outcomes compared to chemotherapy or immunotherapy alone.
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
Lung cancer is a leading cause of cancer death. Immunotherapy using immune checkpoint inhibitors that target proteins like PD-1 and PD-L1 has shown promise in treating lung cancer. A study presented at ASCO 2015 found that treatment with the PD-L1 inhibitor atezolizumab resulted in improved survival for NSCLC patients with higher levels of PD-L1 expression on tumor cells compared to docetaxel chemotherapy. Another study showed nivolumab, a PD-1 inhibitor, improved survival over docetaxel as a treatment for advanced non-squamous NSCLC after chemotherapy, with greater benefit seen in patients with higher PD-L1 expression levels. These results suggest PD-L1 expression can help identify
The document discusses GSK's oncology R&D strategy of maximizing survival through transformational medicines and combinations. It focuses on immuno-oncology, epigenetics, cell and gene therapy. The pipeline includes BCMA and NY-ESO-1 CAR T-cell therapies, OX40 and ICOS agonist antibodies, a TLR4 agonist, and a BET inhibitor showing early efficacy in NUT midline carcinoma. GSK's strategy involves diversifying across modalities, pursuing combination therapies, and building partnerships to sustain a long-term leadership position in oncology.
1. Lung neuroendocrine tumors (NETs) have been increasing in incidence and include typical carcinoid (TC), atypical carcinoid (AC), large-cell neuroendocrine carcinoma (LCNEC), and small-cell lung cancer (SCLC).
2. Diagnosis of lung NETs can be difficult due to non-specific symptoms and frequently involves histopathological examination. Treatment depends on tumor grade and stage.
3. For localized disease, surgery is the primary treatment. For advanced or metastatic NETs, options include somatostatin analogues, targeted therapies like everolimus, chemotherapy, and peptide receptor radionuclide therapy.
The document discusses lung cancer subtypes and molecular features that can guide treatment. It provides statistics on the distribution of histology types among lung cancer cases. It also summarizes several key studies investigating targeted therapies such as EGFR TKIs versus chemotherapy as first-line treatment for advanced non-small cell lung cancer, noting improved progression-free survival with TKIs in patients with EGFR mutations. Molecular testing is increasingly important for determining personalized treatment approaches in lung cancer.
1) Recent immunotherapy advances for advanced NSCLC include the approval of pembrolizumab as a first-line treatment for patients with PD-L1 expression ≥50% based on results from the KEYNOTE-024 trial showing improved progression-free and overall survival compared to chemotherapy.
2) The Phase III KEYNOTE-407 trial found that combining pembrolizumab with chemotherapy improved progression-free survival compared to chemotherapy alone in patients with untreated metastatic squamous NSCLC, regardless of PD-L1 expression level.
3) Combining chemotherapy with immunotherapy may enhance the immune response by increasing antigen presentation, disrupting immune evasion mechanisms, and improving outcomes compared to chemotherapy or immunotherapy alone.
The document summarizes key information from a conference on gene profiling in clinical oncology, including:
1) New markers such as EGFR, KRAS, ALK, HER2, and PI3K mutations are defining subsets of non-small cell lung cancer and informing targeted therapy approaches.
2) Drugs like erlotinib, gefitinib, and crizotinib, which target EGFR, ALK, and c-MET mutations respectively, have shown efficacy in molecularly selected patient populations.
3) Comprehensive genomic profiling of lung tumors is needed to discover new targets, as around a third of cases still have unknown driver mutations.
The document summarizes a presentation on using gene profiling and biomarkers to better classify and treat non-small cell lung cancer (NSCLC). It discusses current and emerging markers like EGFR mutations, ALK translocations, and FGFR1 amplifications that define NSCLC subtypes and can guide targeted therapies. Integrating multiple genomic analyses may help characterize unknown abnormalities in a third of NSCLC tumors and identify new treatment opportunities.
This document summarizes key findings from the SPARTAN clinical trial evaluating the efficacy of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer. The study found that apalutamide significantly reduced the risk of distant metastasis or death by 72% compared to placebo. Apalutamide also improved progression-free survival, time to symptomatic progression, and delayed the time to initiation of cytotoxic chemotherapy. The most common adverse events with apalutamide were fatigue, hypertension, and rash.
2015 04 Tratamiento del NSCLC basado en alteraciones molecularesMartín Lázaro
1) The document discusses biomarker-guided treatment selection for non-small cell lung cancer (NSCLC) and summarizes data from several clinical trials evaluating targeted therapies versus chemotherapy in patients with activating EGFR mutations.
2) The IPASS trial showed that gefitinib resulted in significantly longer progression-free survival compared to carboplatin/paclitaxel in patients with EGFR mutation-positive NSCLC.
3) The EURTAC trial found that erlotinib doubled progression-free survival compared to chemotherapy as first-line treatment for patients with EGFR mutation-positive NSCLC.
Jessica Donington, MD, Natasha Leighl, MD, MMSc, FRCPC, FASCO, and Brendon Stiles, MD, prepared useful practice aids pertaining to the role of immunotherapy in lung cancer for this CME/MOC/CNE activity titled, "The Expanding Role of Immunotherapy in Locally Advanced and Earlier Stages of Lung Cancer: Rationale, Current Evidence, Key Trials, and Implications for Thoracic Surgeons." For the full presentation, monograph, complete CME/MOC/CNE information, and to apply for credit, please visit us at http://bit.ly/2WibbtU. CME/MOC/CNE credit will be available until June 16, 2020.
1. Neuroendocrine tumors (NETs) are increasing in incidence and are often metastatic at diagnosis. They originate from neuroendocrine cells and secrete hormones.
2. Somatostatin analogues are first-line treatment for symptomatic control in NETs but resistance can develop. Chemotherapy has limited efficacy except in high-grade tumors.
3. Emerging biomarkers and molecular targeted therapies such as inhibitors of angiogenesis are improving outcomes beyond traditional approaches.
Role of Chemotherapy, Targeted therapy and Immunotherapy in NSCLC Part IMohammed Fathy
1) Chemotherapy provides a modest survival benefit for early stage NSCLC based on multiple randomized trials. The absolute improvement in 5-year survival is approximately 5%.
2) The IALT trial showed a 4% improvement in 5-year survival with cisplatin-based chemotherapy compared to observation alone for stage I-III NSCLC.
3) The JBR.10 trial demonstrated an 11% absolute improvement in 5-year survival with vinorelbine and cisplatin compared to observation for stage IB-II NSCLC. However, the benefit was largely seen in stage II patients.
While T4 stage, fewer than 12 lymph nodes, and absence of MMR-D are factors considered in deciding adjuvant chemotherapy for Stage II CRC, they are not definitive standards. Currently, there are no established molecular markers that clearly identify patients with high or low risk of recurrence or benefit from chemotherapy for Stage II colon cancer. Researchers are working to develop improved algorithms incorporating clinical, pathological, and emerging molecular markers to better guide treatment decisions.
David R. Jones, MD, and Roy S. Herbst, MD, PhD, prepared useful practice aids pertaining to lung cancer for this CME activity titled "Turning Tides in Targeted Therapy for Early-Stage EGFR-Mutated NSCLC: Latest Data and Practical Guidance for Thoracic Surgeons and the Multidisciplinary Team on the Emerging Role of EGFR-Targeted Therapy in Resectable Lung Cancer." For the full presentation, complete CME information, and to apply for credit, please visit us at https://bit.ly/2PSVELG. CME credit will be available until November 9, 2021.
Robert Anders, MD, PhD, Robert L. Ferris, MD, PhD, and Lauren L. Ritterhouse, MD, PhD, prepared useful Practice Aids pertaining to biomarker testing for this CME/MOC activity titled "The Central Role of Biomarker Testing in Piecing Together the Immuno-Oncology Puzzle: Essential Guidance for Pathologists to Maximize the Potential of Cancer Immunotherapies." For the full presentation, monograph, complete CME/MOC information, and to apply for credit, please visit us at http://bit.ly/2QAudYX. CME/MOC credit will be available until December 26, 2019.
Ohio State's ASH Review 2017 - Update in MyelomaOSUCCC - James
Don M. Benson Jr., MD, PhD, FACP
Associate Professor of Medicine
Head of Translational Research
Division of Hematology
The Ohio State University Comprehensive Cancer Center -
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Biomarkers in head and neck cancers final ajeetAjeet Gandhi
This document provides an overview of biomarkers in head and neck cancers. It discusses how biomarkers can be used for early diagnosis, predicting response to therapy, and identifying therapeutic targets. Key points include:
- Biomarkers like HPV status, ERCC1, and beta-tubulin isoform III may help predict response to chemotherapy and radiation. HPV+ tumors have a better prognosis.
- The EGFR pathway is commonly dysregulated in head and neck cancers but targeting it has had limited success due to resistance mechanisms. EGFRvIII mutations may reduce sensitivity to cetuximab.
- Ongoing research explores using biomarkers to guide more personalized treatment, such as reducing therapy for HPV+ tumors or targeting pathways
Role of Chemotherapy, Targeted therapy and Immunotherapy in NSCLC (Part II)Mohammed Fathy
1) The document discusses targeted therapies for non-small cell lung cancer (NSCLC) with ALK translocations, including crizotinib, alectinib, brigatinib, ceritinib, and lorlatinib.
2) Alectinib is now considered the preferred first-line treatment for ALK-positive NSCLC based on Phase III trials showing it is more effective than crizotinib.
3) For patients who progress on a first-generation ALK inhibitor like crizotinib, later-generation ALK inhibitors such as ceritinib, brigatinib, and lorlatinib have demonstrated efficacy in clinical trials as subsequent therapies.
This document provides guidance on the use of Bristol-Myers Squibb (BMS) content for scientific exchange with healthcare professionals (HCPs) regarding nivolumab and metastatic renal cell carcinoma (mRCC). Key points include:
- BMS material may be used reactively for scientific exchange with HCPs and provided to HCPs requesting medical information.
- If appropriate based on country approval status, inform HCPs if information provided is off-label.
- The material was approved for use as described by BMS medical and obtained necessary permissions.
- External use requires appropriate medical, regulatory and legal review per local rules.
The document summarizes current diagnosis and treatment strategies for neuroendocrine tumors. It discusses the classification and grading of neuroendocrine tumors based on primary tumor site and biomarkers like Ki67. Imaging techniques like octreoscan, MIBG scintigraphy, and PET using tracers like 18F-DOPA and 68Ga-DOTA-octreotide are described. Treatment options discussed include surgery, medical therapies like somatostatin analogs, chemotherapy, targeted radionuclide therapy using 177Lu-DOTA-octreotate and peptide receptor radionuclide therapy.
The document summarizes key information from a conference on gene profiling in clinical oncology, including:
1) New markers such as EGFR, KRAS, ALK, HER2, and PI3K mutations are defining subsets of non-small cell lung cancer and informing targeted therapy approaches.
2) Drugs like erlotinib, gefitinib, and crizotinib, which target EGFR, ALK, and c-MET mutations respectively, have shown efficacy in molecularly selected patient populations.
3) Comprehensive genomic profiling of lung tumors is needed to discover new targets, as around a third of cases still have unknown driver mutations.
The document summarizes a presentation on using gene profiling and biomarkers to better classify and treat non-small cell lung cancer (NSCLC). It discusses current and emerging markers like EGFR mutations, ALK translocations, and FGFR1 amplifications that define NSCLC subtypes and can guide targeted therapies. Integrating multiple genomic analyses may help characterize unknown abnormalities in a third of NSCLC tumors and identify new treatment opportunities.
This document summarizes key findings from the SPARTAN clinical trial evaluating the efficacy of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer. The study found that apalutamide significantly reduced the risk of distant metastasis or death by 72% compared to placebo. Apalutamide also improved progression-free survival, time to symptomatic progression, and delayed the time to initiation of cytotoxic chemotherapy. The most common adverse events with apalutamide were fatigue, hypertension, and rash.
2015 04 Tratamiento del NSCLC basado en alteraciones molecularesMartín Lázaro
1) The document discusses biomarker-guided treatment selection for non-small cell lung cancer (NSCLC) and summarizes data from several clinical trials evaluating targeted therapies versus chemotherapy in patients with activating EGFR mutations.
2) The IPASS trial showed that gefitinib resulted in significantly longer progression-free survival compared to carboplatin/paclitaxel in patients with EGFR mutation-positive NSCLC.
3) The EURTAC trial found that erlotinib doubled progression-free survival compared to chemotherapy as first-line treatment for patients with EGFR mutation-positive NSCLC.
Jessica Donington, MD, Natasha Leighl, MD, MMSc, FRCPC, FASCO, and Brendon Stiles, MD, prepared useful practice aids pertaining to the role of immunotherapy in lung cancer for this CME/MOC/CNE activity titled, "The Expanding Role of Immunotherapy in Locally Advanced and Earlier Stages of Lung Cancer: Rationale, Current Evidence, Key Trials, and Implications for Thoracic Surgeons." For the full presentation, monograph, complete CME/MOC/CNE information, and to apply for credit, please visit us at http://bit.ly/2WibbtU. CME/MOC/CNE credit will be available until June 16, 2020.
1. Neuroendocrine tumors (NETs) are increasing in incidence and are often metastatic at diagnosis. They originate from neuroendocrine cells and secrete hormones.
2. Somatostatin analogues are first-line treatment for symptomatic control in NETs but resistance can develop. Chemotherapy has limited efficacy except in high-grade tumors.
3. Emerging biomarkers and molecular targeted therapies such as inhibitors of angiogenesis are improving outcomes beyond traditional approaches.
Role of Chemotherapy, Targeted therapy and Immunotherapy in NSCLC Part IMohammed Fathy
1) Chemotherapy provides a modest survival benefit for early stage NSCLC based on multiple randomized trials. The absolute improvement in 5-year survival is approximately 5%.
2) The IALT trial showed a 4% improvement in 5-year survival with cisplatin-based chemotherapy compared to observation alone for stage I-III NSCLC.
3) The JBR.10 trial demonstrated an 11% absolute improvement in 5-year survival with vinorelbine and cisplatin compared to observation for stage IB-II NSCLC. However, the benefit was largely seen in stage II patients.
While T4 stage, fewer than 12 lymph nodes, and absence of MMR-D are factors considered in deciding adjuvant chemotherapy for Stage II CRC, they are not definitive standards. Currently, there are no established molecular markers that clearly identify patients with high or low risk of recurrence or benefit from chemotherapy for Stage II colon cancer. Researchers are working to develop improved algorithms incorporating clinical, pathological, and emerging molecular markers to better guide treatment decisions.
David R. Jones, MD, and Roy S. Herbst, MD, PhD, prepared useful practice aids pertaining to lung cancer for this CME activity titled "Turning Tides in Targeted Therapy for Early-Stage EGFR-Mutated NSCLC: Latest Data and Practical Guidance for Thoracic Surgeons and the Multidisciplinary Team on the Emerging Role of EGFR-Targeted Therapy in Resectable Lung Cancer." For the full presentation, complete CME information, and to apply for credit, please visit us at https://bit.ly/2PSVELG. CME credit will be available until November 9, 2021.
Robert Anders, MD, PhD, Robert L. Ferris, MD, PhD, and Lauren L. Ritterhouse, MD, PhD, prepared useful Practice Aids pertaining to biomarker testing for this CME/MOC activity titled "The Central Role of Biomarker Testing in Piecing Together the Immuno-Oncology Puzzle: Essential Guidance for Pathologists to Maximize the Potential of Cancer Immunotherapies." For the full presentation, monograph, complete CME/MOC information, and to apply for credit, please visit us at http://bit.ly/2QAudYX. CME/MOC credit will be available until December 26, 2019.
Ohio State's ASH Review 2017 - Update in MyelomaOSUCCC - James
Don M. Benson Jr., MD, PhD, FACP
Associate Professor of Medicine
Head of Translational Research
Division of Hematology
The Ohio State University Comprehensive Cancer Center -
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Biomarkers in head and neck cancers final ajeetAjeet Gandhi
This document provides an overview of biomarkers in head and neck cancers. It discusses how biomarkers can be used for early diagnosis, predicting response to therapy, and identifying therapeutic targets. Key points include:
- Biomarkers like HPV status, ERCC1, and beta-tubulin isoform III may help predict response to chemotherapy and radiation. HPV+ tumors have a better prognosis.
- The EGFR pathway is commonly dysregulated in head and neck cancers but targeting it has had limited success due to resistance mechanisms. EGFRvIII mutations may reduce sensitivity to cetuximab.
- Ongoing research explores using biomarkers to guide more personalized treatment, such as reducing therapy for HPV+ tumors or targeting pathways
Role of Chemotherapy, Targeted therapy and Immunotherapy in NSCLC (Part II)Mohammed Fathy
1) The document discusses targeted therapies for non-small cell lung cancer (NSCLC) with ALK translocations, including crizotinib, alectinib, brigatinib, ceritinib, and lorlatinib.
2) Alectinib is now considered the preferred first-line treatment for ALK-positive NSCLC based on Phase III trials showing it is more effective than crizotinib.
3) For patients who progress on a first-generation ALK inhibitor like crizotinib, later-generation ALK inhibitors such as ceritinib, brigatinib, and lorlatinib have demonstrated efficacy in clinical trials as subsequent therapies.
This document provides guidance on the use of Bristol-Myers Squibb (BMS) content for scientific exchange with healthcare professionals (HCPs) regarding nivolumab and metastatic renal cell carcinoma (mRCC). Key points include:
- BMS material may be used reactively for scientific exchange with HCPs and provided to HCPs requesting medical information.
- If appropriate based on country approval status, inform HCPs if information provided is off-label.
- The material was approved for use as described by BMS medical and obtained necessary permissions.
- External use requires appropriate medical, regulatory and legal review per local rules.
The document summarizes current diagnosis and treatment strategies for neuroendocrine tumors. It discusses the classification and grading of neuroendocrine tumors based on primary tumor site and biomarkers like Ki67. Imaging techniques like octreoscan, MIBG scintigraphy, and PET using tracers like 18F-DOPA and 68Ga-DOTA-octreotide are described. Treatment options discussed include surgery, medical therapies like somatostatin analogs, chemotherapy, targeted radionuclide therapy using 177Lu-DOTA-octreotate and peptide receptor radionuclide therapy.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET). Phase 1 and 2 trials show it has a favorable safety profile compared to immediate release anagrelide with fewer adverse events. A pivotal Phase 3 trial is planned for Q2 to initiate comparing GALE-401 to best available therapies in patients who failed or were intolerant to hydroxyurea.
NeuVax is an investigational immunotherapy targeting HER2-positive breast cancer. It contains an immunodominant HER2 peptide that stimulates CD8+ T-cells to destroy tumor cells. Phase 2 trials are ongoing in various breast cancer populations in combination with Hercept
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
GALE-401 is a controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia. Phase 1 and 2 trials show it has an improved tolerability and safety profile compared to immediate release anagrelide, with a faster onset of platelet lowering effect. The company plans to initiate a pivotal Phase 3 trial in 2017 to evaluate GALE-401's ability to reduce platelet counts in essential thrombocythemia patients. NeuVax is an immunotherapy targeting HER2-positive breast cancer that elicits a strong CD8+ T-cell immune response. It is being evaluated in multiple clinical trials in various breast and gastric cancer settings both as a monotherapy and in combination with other agents like tra
Estudio Paramount cáncer de pulmón 2014Martín Lázaro
1) The PARAMOUNT study evaluated pemetrexed maintenance therapy after induction with pemetrexed/cisplatin doublet chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
2) The study met its primary endpoint, finding that pemetrexed maintenance significantly reduced the risk of disease progression compared to placebo (HR=0.62, p<0.0001).
3) Updated results showed pemetrexed maintenance also significantly improved overall survival compared to placebo, with median OS of 13.9 months vs 11 months (HR=0.78, p=0.0199).
This document discusses adrenal cortical carcinoma (ACC), a rare but aggressive form of cancer. It provides information on the epidemiology, clinical presentation, prognostic factors, treatment approaches including mitotane and chemotherapy, and clinical trials for ACC. Recent studies have found that achieving mitotane plasma levels above 14 mg/L within 3 months of treatment and maintaining these levels is associated with better outcomes for patients with ACC. Larger international collaborations are working to advance the treatment of this disease.
Ym bio sciences corppres ash2012 dec 10 12YMBioSciences
CYT387 is a JAK1/JAK2 inhibitor being studied for the treatment of myelofibrosis. A phase I/II study found that CYT387 showed promising efficacy based on three key measures: (1) It converted over 68% of transfusion dependent patients to transfusion independence; (2) It reduced spleen size in over 37% of patients based on IWG-MRT criteria; and (3) It improved constitutional symptoms in the majority of patients. The safety profile was acceptable with the most common adverse events being low grade thrombocytopenia and anemia. The study demonstrated that CYT387 has a favorable risk-benefit profile for the treatment of myelofibrosis.
YM BioSciences CorpPres ASH2012 Dec 10 12YMBioSciences
CYT387 is a JAK1/JAK2 inhibitor being studied for the treatment of myelofibrosis. A phase I/II study found that CYT387 showed promising efficacy based on three key measures: (1) It converted over 68% of transfusion dependent patients to transfusion independence; (2) It reduced spleen size in over 37% of patients based on IWG-MRT criteria; and (3) It improved constitutional symptoms in the majority of patients. The safety profile was acceptable with the most common adverse events being low grade thrombocytopenia and anemia. The study demonstrated that CYT387 has a favorable risk-benefit profile for the treatment of myelofibrosis.
This document discusses therapeutic options for first line treatment of advanced non-small cell lung cancer (NSCLC). It provides details on chemotherapy regimens such as platinum doublets with paclitaxel, gemcitabine or docetaxel. It also discusses targeted therapies like bevacizumab, erlotinib and gefitinib. The document reviews clinical trials that established current standard first line treatments and highlights the need for personalized treatment based on tumor markers and mutations.
Personalized vs. Precision, let’s call it Medicineflasco_org
This document discusses the integration of precision oncology and hematology into clinical practice. It begins by outlining the clinical problem of multiple treatment options for most diseases and unpredictable toxicity. It then discusses practical choices in selecting amongst equivalent options and using clinical trial data and probabilistic risk assessment to guide interventions. Examples are given of pharmacogenomic biomarkers that can guide cancer treatment selection. Next-generation sequencing is discussed as a tool to further analyze tumor genomes. Implementation challenges and opportunities in clinical practice are reviewed including multidisciplinary tumor boards and tracking results. The need to validate biomarkers in robust data and apply them is emphasized to determine the potential of precision oncology.
This document provides a summary of neuroendocrine tumors (NETs):
- NETs arise from neuroendocrine cells throughout the body and can be functional or nonfunctional. Gastroenteropancreatic NETs are the most prevalent.
- NET incidence has increased 5-fold over the past 30 years. They are often advanced at diagnosis due to nonspecific symptoms and long diagnostic delays.
- Treatment options include surgery, chemotherapy, targeted therapies like somatostatin analogues, interferon, and newer agents inhibiting angiogenesis and mTOR pathways. Clinical trials are evaluating these targeted agents.
- The PI3K/Akt/mTOR pathway is frequently deregulated in cancers including NETs and represents a
A hematology and oncology focused company has a diversified pipeline with multiple mid-to-late stage clinical trials. Their lead program is GALE-401 for essential thrombocythemia, which is a controlled release formulation of anagrelide in Phase 3 ready. Their immunotherapy programs include NeuVax for HER2-positive breast cancer in multiple Phase 2 trials in combination with Herceptin, and GALE-301/302 targeting folate binding protein in early stage trials.
Targovax Next generation immune activators for solid tumorsRoarFredriksen1
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax’s focus is to activate the patient’s immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, and has demonstrated a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system against the tumor. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.
Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovax is researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.
1. The document discusses individualized systemic therapy for non-small cell lung cancer (NSCLC), focusing on biomarkers like ERCC1, BRCA1, and EGFR mutations that can help customize chemotherapy based on a patient's tumor genetics.
2. Clinical trials show that targeting therapies like EGFR tyrosine kinase inhibitors provide significant benefits for NSCLC patients with EGFR mutations, with response rates over 70% in some studies.
3. Ongoing research aims to identify additional biomarkers to further personalize treatment selection and overcome resistance to targeted therapies.
This document summarizes research on biochemical and imaging markers for cardiovascular disease. It includes 3 sections:
1. It discusses several major risk factors for cardiovascular events and how biomarkers like CRP, fibrinogen, and homocysteine can provide additional predictive value beyond traditional risk factors.
2. It reviews studies on emerging biomarkers for inflammation, thrombosis, and oxidative stress, and their association with future cardiovascular outcomes in prospective studies.
3. It presents data on imaging markers like carotid intimal thickness, echocardiography, and electron beam computed tomography and their ability to track disease severity and response to treatment.
The document concludes by discussing features of an ideal cardiovascular biomarker and potential surrogate markers of endothelial function
3.Case Based Moderation Slidedeck 110_130_150.pptxBipineshSansar
This document discusses treatment options for patients with metastatic non-small cell lung cancer (NSCLC) without driver mutations. First-line options include cancer immunotherapy (CIT) monotherapy, CIT plus chemotherapy, CIT plus chemotherapy plus anti-VEGF. Second-line options include chemotherapy, CIT doublet, or anti-angiogenic plus chemotherapy. CIT is not an option in later lines if already given in earlier lines. The document also discusses predictive biomarkers for CIT efficacy and immune checkpoint inhibitors.
Chair, David M. O'Malley, MD, Ana Oaknin, MD, PhD, and Matthew A. Powell, MD, prepared useful Practice Aids pertaining to endometrial cancer for this CME/MOC/AAPA activity titled “Endometrial Cancer Care in the Age of Immunotherapy: Translating Clinical Evidence Into Meaningful Improvements in Patient Outcomes Across the Disease Continuum.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at https://bit.ly/40bmalK. CME/MOC/AAPA credit will be available until July 3, 2024.
This document summarizes current dilemmas in early management of castration-resistant prostate cancer (CRPC). It discusses definitions of CRPC and its natural history progression. Factors contributing to inevitable disease progression despite androgen deprivation therapy include alternate androgen biosynthesis, androgen receptor abnormalities, proliferation cascades, and changes in histology. Genetic alterations in prostate cancer like BRCA mutations are also reviewed. Recent positive clinical trial results establishing new standards of care for both chemo-naïve and post-docetaxel CRPC are highlighted. Optimal sequencing of available therapies remains an area of ongoing research due to heterogeneity in patient populations and lack of head-to-head trials.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
ZKsync airdrop of 3.6 billion ZK tokens is scheduled by ZKsync for next week.pdfSOFTTECHHUB
The world of blockchain and decentralized technologies is about to witness a groundbreaking event. ZKsync, the pioneering Ethereum Layer 2 network, has announced the highly anticipated airdrop of its native token, ZK. This move marks a significant milestone in the protocol's journey, empowering the community to take the reins and shape the future of this revolutionary ecosystem.
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2. 2
Forward-Looking Statement of
Merck & Co., Inc., Kenilworth, NJ, USA
This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-
looking statements” within the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements are based upon the current
beliefs and expectations of the company’s management and are subject to significant risks and
uncertainties. There can be no guarantees with respect to pipeline products that the products
will receive the necessary regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and currency exchange rate
fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the
United States and internationally; global trends toward healthcare cost containment;
technological advances, new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory approval; the company’s
ability to accurately predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk; dependence on the
effectiveness of the company’s patents and other protections for innovative products; and the
exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise. Additional factors that could
cause results to differ materially from those described in the forward-looking statements can
be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings
with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site
(www.sec.gov).
3. Topics we will cover
Merck Strategy in Oncology1
Key Data presented at ESMO 20162
Executing Global Launch3
Q&A4
3
4. 4
Identify patients most likely to benefit from KEYTRUDA through
evaluation of biomarkers
Establish KEYTRUDA as foundational treatment
in monotherapy and in combination across multiple tumor types
Extend and Improve the lives of people worldwide
suffering from a wide range of cancers
Explore combinations with standard of care and novel agents
including other immune modulators
Merck’s Oncology Strategy
5. 5
First anti-PD-1 to market in the U.S.
Approvals in NSCLC (2L+ PD-L1+), Melanoma (1L+), H&N (2L+)
Demonstrated overall survival as Monotherapy
- vs. ipilimumab in melanoma
- vs. docetaxel in 2L PD-L1+ NSCLC
- vs. platinum doublet in 1L PD-L1 50%+ NSCLC
Demonstrated Progression Free Survival in combination with Chemo
- vs. platinum doublet in 1L Non squamous NSCLC
Launching in >50 markets globally (melanoma) / >30 markets (lung)
Clinical activity in more than 20 tumor types
More than 30 registration-enabling studies ongoing
FDA Breakthrough Designations
- melanoma, 2L NSCLC, MSI-H, Hodgkin Lymphoma and 1L NSCLC
Progress since ASCO 2016
Significant progress made in the last 5 years since
KEYTRUDA entered the clinic
6. 6
REGISTRATIONEARLY DEVELOPMENT
BET-Bromodomain (MK-8628)
GITR (MK-4166)
IL-10 (MK-1966)
Melanoma
1L (KN006)
2L (KN002)
Adjuvant (KN053/054)
1L + T-Vec (Amgen)
1L + IDO-1 (Incyte)
NSCLC
1L (KN024)
1L (KN042)
1L + pemetrexed non sq (KN189)
1L + pacitaxel sq(KN407)
2/3L (KN010)
Adjuvant (KN091)
Head and Neck
1L + chemo/cetuximab (KN048)
2L (KN040)
3L (KN055)
2L Nasopharyngeal (KN122)
Bladder
1L (KN052)
1L (KN361)
2L NIBC (KN057)
2L (KN045)
Gastrointestinal
1L Gastric + chemo (KN062)
2L Gastric (KN061)
3L Gastric (KN059)
2L Esophageal (KN181)
3L Esophageal (KN180)
1L CRC MSI-high (KN177)
3L CRC MSI-high (KN164)
Triple Negative Breast
2L+ (KN086)
2L/3L (KN119)
Hematological Malignancies
3L HL (KN087)
rrHL + brent. ved. (KN204)
2L NHL rrPMBCL (KN170)
1L MM + len/dex (KN185)
3L rrMM + pom/dex (KN183)
CEACAM1 (MK-6018)
Other
2L Ovarian (KN100)
2L Prostate (KN199)
1L Renal Cell Carcinoma (KN427)
1L + Axitinib Renal Cell Carcinoma (KN426)
CDK 1,2,5,9 (MK-7965)
Hepatocellular
2L (KN224)
2L (KN240)
LAG-3 (MK-4280)
Additional I-O Preclinical Programs
GITR (MK-1248)
PI3K Delta (MK-1822)
Clinical ProgramsKEYTRUDA
The Broadest Program of Any Anti-PD-1/PD-L1 Drug
More than 350 trials in more than 30 tumors; More than 100 Combination Trials
7. 7
Summary of major KEYTRUDA sessions only—in total, findings from 30 studies across 12
different cancer types have been presented at ESMO 2016
Lung
• Keynote-024: vs. Chemo as 1L NSCLC (TPS≥50%) - Oral
• Keynote-021G: + Carboplatin and Pematrexed as 1L - Oral
• Keynote-001,010,024: Prevalence of PD-L1 expression - Poster
• Keynote-010: vs. Docetaxal NSCLC – Longer follow-up - Poster
• Keynote-098: Safety and activity in combo with Ramucirumab - Poster
GU
• Keynote-052: 1L bladder - Oral
• Keynote-028: Prostate adenocarcinoma - Poster
• Keynote-035: Combo with Axitinib in renal cell carcinoma - Poster
Melanoma
and
Head & neck
• Keynote-002: OS data in Melanoma – Longer follow-up - Oral
• Keynote-055: Head and Neck after Platinum and Cetuximab - Poster
Several KEYTRUDA studies in multiple tumor types
have been presented during ESMO
8. 8
• Many potential new filings across multiple
tumor types
• Anticipated approvals for NSCLC in
multiple jurisdictions
• Additional novel combination data
• Additional internal I-O targets moving into
the clinic
What we expect over the next 12 months
9. Topics we will cover
9
Merck Strategy in Oncology1
Key Data presented at ESMO 20162
Executing Global Launch3
Q&A4
12. 12
KEYNOTE-024 Study Design and Key End-Points
Study Design
Pembrolizumab
200 mg IV Q3W
(2 years)
Pembrolizumab
200 mg Q3W
for 2 years
Platinum-Doublet
Chemotherapy
(4-6 cycles)
Key Eligibility criteria
• Untreated stage IV NSCLC
• PD-L1 TPS ≥50%
• ECOG PS 0-1
• No activating EGFR mutation or
ALK translocation
• No untreated brain metastases
• No active autoimmune disease
requiring systemic therapy
R (1:1)
N = 305
50% crossover in ITT population
54% crossover excluding ongoing pts
Key end-points
Primary: PFS (RECIST v1.1 per
blinded, independent central
review)
Secondary: OS, ORR, safety
Exploratory: DOR
PD
13. 13
KEYNOTE-024 Baseline Characteristics
Pembro
N = 154
Chemo
N = 151
Median age (range), y 64.5 (33-90) 66.0 (38-85)
Men, n (%) 92 (60) 95 (63)
Enrolled in east Asia 21 (14) 19 (13)
ECOG PS 1, n (%) 99 (64) 98 (65)
Squamous histology, n (%) 29 (19) 27 (18)
Smoking status,a n (%)
Current
Former
Never
34 (22)
115 (75)
5 (3)
31 (21)
101 (67)
19 (13)
Brain metastases, n (%) 18 (12) 10 (7)
15. 15
KEYNOTE-024 Overall Survival and Objective
Response
40% risk reduction of death
50% crossover in ITT population
54% crossover excluding ongoing pts
16. 16
KEYNOTE-024 Exposure and AE Summary
Data cut-off: May 9, 2016.
Pembrolizumab
N = 154
Chemotherapy
N = 150
Exposure, median (range)
7.0 mo
(1 d-18.7 mo)
3.5 mo
(1 d-16.8 mo)
Treatment-related AEs, n (%) 113 (73) 135 (90)
Grade 3-4 40 (26) 77 (51)
Serious 33 (21) 31 (21)
Led to discontinuation 11 (7) 16 (11)
Led to death 1 (<1) 3 (2)
19. 19
KEYNOTE-021 Cohort G Study Design
Pembrolizumab 200 mg
Q3W for 2 years +
Carboplatin AUC 5
mg/mL/min +
Pemetrexed 500 mg/m2
Q3W for 4 cyclesb
Pembrolizumab
200 mg Q3W
for 2 years
Carboplatin AUC 5
mg/mL/min +
Pemetrexed 500
mg/m2
Q3W for 4 cyclesb
Key Eligibility criteria
• Untreated stage IIIB or IV
nonsquamous NSCLC
• No activating EGFR mutation or ALK
translocation
• Provision of a sample for
PD-L1 assessmenta
• ECOG PS 0-1
• No untreated brain metastases
• No ILD or pneumonitis requiring
systemic steroids
R (1:1)a
N = 123
51% crossover in ITT population
73% crossover excluding ongoing pts
Primary: ORR (RECIST v1.1 per
blinded, independent central
review)
Key secondary: PFS
Other secondary: OS, safety
Exploratory: Relationship between
antitumor activity and PD-L1 TPS
PD
aRandomization was stratified by PD-L1 TPS <1% vs ≥1%.
bIndefinite maintenance therapy with pemetrexed 500 mg/m2 Q3W permitted.
Key end-points
20. 20
KEYNOTE-021 Cohort G Baseline
Characteristics
Pembro + Chemo
N = 60
Chemo Alone
N = 63
Median age (range), y 62.5 (40-77) 66.0 (37-80)
Women, n (%) 38 (63) 37 (59)
ECOG PS 1, n (%) 35 (58) 34 (54)
Adenocarcinoma histology, n (%) 58 (97) 55 (87)
Stage IV disease, n (%) 59 (98) 60 (95)
Smoking status, n (%)
Current or former
Never
45 (75)
15 (25)
54 (86)
9 (14)
Stable brain metastases, n (%) 9 (15) 6 (10)
PD-L1 TPS, n (%)
<1%
1%-49%
≥50%
21 (35)
19 (32)
20 (33)
23 (37)
23 (37)
17 (27)
21. 21
KEYNOTE-021 Cohort G Overall Response and
by PD-L1 TPS
Significant ORR benefit with
KEYTRUDA combo in PD-L1
negative and PD-L1 positive patients
ORR nearly doubled with
KEYTRUDA combo vs.
chemo alone
22. 22
KEYNOTE-021 Cohort G Progression Free
Survival and Overall Survival
47% risk reduction of
disease progression
Median PFS = 13.0 Months
51% crossover in ITT population
73% crossover excluding ongoing pts
23. 23
Pembro + Chemo
n = 59
Chemo Alone
n = 62
Exposure, median (range)
8.0 mo
(1 d - 16.1 mo)
4.9 mo
(1 d - 15.3 mo)
Treatment-related AEs, n (%) 55 (93) 56 (90)
Grade 3-4 23 (39) 16 (26)
Led to discontinuation 6 (10) 8 (13)
Led to death 1 (2) 2 (3)
Data cut-off: August 8, 2016.
KEYNOTE-021 Cohort G Exposure and
AE Summary
25. 25
KEYNOTE-052 Study Design
Pembrolizumab
200 mg Q3W
Primary Endpoints
• ORR in all patients
• ORR in patients with
PD-L1–positive tumors
Patients (N = 350)
• Advanced urothelial cancer
• No prior chemotherapy for
metastatic disease
• ECOG PS 0-2
• Ineligible for cisplatin
based on ≥ 1 of the
following:
– CrCl <60 mL/min
– ECOG PS 2
– ≥ grade 2 neuropathy or
hearing loss
– NYHA class III CHF
Secondary Endpoints: DOR, PFS, OS, and ORR in all patients,
PD-L1 positive and PD-L1–high expressing patients; safety and
tolerability; establish an assay cut point for high
PD-L1 expression
First 100 patients included in this planned interim analysis
• Evaluate ORR
• Determine the PD-L1–high expression cut point
26. 26
KEYNOTE-052 Baseline Characteristics
Characteristic
N = 100
n (%)
Age, median (range), years
≥80 years, n (%)
75 (44-94)
34 (34)
Male, n (%) 76 (76)
ECOG performance status, n (%)
0
1
2
24 (24)
30 (30)
45 (45)
Primary tumor location, n (%)
Upper tract (renal pelvis/ureter)
Lower tract (bladder/urethra)
20 (20)
80 (80)
Metastases location, n (%)
Lymph node only
Visceral disease₴
Liver metastasis
10 (10)
87 (87)
27 (27)
Treatment
N = 100
n (%)
Prior perioperative therapy 13 (13)
Prior BCG therapy 10 (10)
Reason for cisplatin ineligibility
ECOG PS 2†
Renal dysfunction‡
Grade ≥2 peripheral neuropathy
Grade ≥2 hearing loss
ECOG PS 2 and renal dysfunction
43 (43)
45 (45)
2 (2)
10 (10)
11 (11)
₴Defined as metastases involving liver, lung, bone, any non-lymph node, or soft tissue
†ECOG performance status assessed during screening
‡Renal dysfunction defined as creatinine clearance < 60 ml/min
Data cutoff date: June 1, 2016
27. 27
KEYNOTE-052 Objective Response Rate
N = 100 n % (95% CI)
Objective response rate (CR + PR) 24 24% (16-34)
Complete response 6 6% (2-13)
Partial response 18 18% (11-27)
Stable disease 15 15% (9-24)
Progressive disease 48 48% (38-58)
Non-evaluable† 3 3% (1-9)
No assessment‡ 10 10% (5-18)
Only confirmed responses are reported. CR = complete response; PR = partial response. Data cutoff date: June 1, 2016
†3 patients had stable disease within 6 weeks of treatment start and then discontinued.
‡10 patients dropped out of the study before the 1st post-baseline imaging, either due to clinical progression or AE.
Confirmed Objective Response Rate Per RECIST v1.1, Central Review
29. 29
Treatment Related Adverse Events
Treatment-Related AEs
N = 100
Any Grade
n (%)
Grade 3-4
n (%)
Any 67 (67) 16 (16)
Fatigue 14 (14) 4 (4)
Pruritus 12 (12) 0
Pyrexia 8 (8) 0
Decreased appetite 7 (7) 1 (1)
Diarrhea 7 (7) 1 (1)
Rash 7 (7) 0
Chills 6 (6) 0
Nausea 6 (6) 0
Muscle spasms 2 (2) 2 (2)
Table includes any-grade treatment-related AEs observed in ≥5 patients
and grade 3-4 treatment-related AEs observed in ≥2 patients as reported.
Data cutoff date: June 1, 2016
Immune-Mediated AEs of Special Interest†
N = 100
n (%)
Hypothyroidism
Grade 2 6 (6)
Pneumonitis
Grade 2
Grade 3
1 (1)
2 (2)
Nephritis
Grade 3 1 (1)
Colitis
Grade 3 1 (1)
• Low discontinuation (5%) due to treatment-related AEs
• No deaths due to treatment-related AEs
30. 30
Key takeaways from KEYNOTE studies
presented at ESMO
• KEYTRUDA is the only anti PD-1 to demonstrate superior
efficacy in 1L NSCLC treatment in randomized controlled
clinical trials
• KEYTRUDA should become foundation of treatment for
substantial portion of 1L metastatic NSCLC patients either as
monotherapy or in combination with chemotherapy
– PD-L1 testing will allow for the selection of patients for
whom monotherapy will be optimal in terms of benefit / risk
• KEYTRUDA demonstrate significant anti-tumor activity across
multiple tumor types, including in 1L Bladder cancer as
reported in KN-052 during ESMO
31. Topics we will cover
31
Merck Strategy in Oncology1
Key Data presented at ESMO 20162
Executing Global Launch3
Q&A4
32. 32
We are launching KEYTRUDA globally across
several tumor types… with more to come
• Executing our strategy as a leader in oncology
• Investing behind launches around the world
– Melanoma in more than 50 markets
– Lung in more than 30 markets
– Head and Neck in the U.S.
• Discussing value of biomarkers with payers and clinicians
worldwide to guide meaningful clinical decision-making
and optimize patient treatment
• Preparing for potential additional launches, including 1L
NSCLC