Tracking All the Targets in Genomically Altered NSCLC: Everything You Need to Know About Biomarker Testing and Treatment
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Chair & Presenter, Stephen V. Liu, MD, D. Ross Camidge, MD, PhD, Alexander Drilon, MD, and Zofia Piotrowska, MD, prepared useful Practice Aids pertaining to non–small cell lung cancer for this CME/MOC/CC/NCPD activity titled “Tracking All the Targets in Genomically Altered NSCLC: Everything You Need to Know About Biomarker Testing and Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/NCPD information, and to apply for credit, please visit us at https://bit.ly/2Q6KrKQ. CME/MOC/CC/NCPD credit will be available until July 5, 2022.
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Tracking All the Targets in Genomically Altered NSCLC: Everything You Need to Know About Biomarker Testing and Treatment
- 1. LUNGevity Foundation: Lung Cancer Resource Compendium1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 A lung cancer diagnosis can be overwhelming. However, many treatments are available. Currently, approximately 50% of people with adenocarcinoma (a type of NSCLC) have a biomarker that has a corresponding targeted therapy. Your doctor can help to guide you through the treatment decision-making process. It is important to consider your biomarker test results and your individual needs, values, and preferences. Depending on your biomarker results, you may be eligible for an approved therapy or a clinical trial of an investigational treatment. It is important to discuss all aspects of your care with your doctor and family/caregivers to ensure that you receive the treatment that is right for you. Ask your doctor about: • Your biomarker results and what they mean for treatment • The risks, benefits, and costs of all treatment options • What to expect before, during, and after treatment ! Knowing your biomarker status may allow you to access treatment that can be very effective for your specific NSCLC https://lungevity.org Biomarkers with approved targeted therapies • EGFR mutations (including exon 20) • ALK rearrangements • ROS1 rearrangements • BRAF V600E mutation Currently, 8 biomarkers in NSCLC have FDA-approved targeted therapies. Clinical trials are evaluating targeted therapies for other biomarkers. If a clinical trial is the best treatment option for you, support is available: • Ask to speak with a clinical trial coordinator at your treating institution • Call the LUNGevity Clinical Trial Matching Service at 1-877-769-4834 • Visit the LUNGevity Clinical Trial Finder: https://clinicaltrials.lungevity.org/ • NTRK fusions • MET exon 14 skipping mutations • RET fusions • KRAS G12C mutation LUNGevity is a national patient advocacy organization dedicated to supporting all lung cancer patients. Contact the LUNGevity helpline at 844-360-5864 or visit www.lungevity.org. If you have a targetable biomarker, LUNGevity can direct you to patient groups dedicated to supporting people with these biomarkers. Remember, you are not alone! Lung cancer diagnosis Biomarker testing Discuss results with doctor Begin treatment It’s important to wait for biomarker testing results whenever possible before starting therapy. It can take 4 weeks or longer to get these results, but your healthcare team can’t make the best treatment plan without having this information. • Learn more about biomarker testing: https://lungevity.org/noonemissed • Hear from other patients who have undergone biomarker testing: https://lungevity.org/biomarkertesting • Contact LUNGevity’s peer-to-peer support coordinator at 312-407-6116 to be connected with someone who has been in your shoes Comprehensive biomarker testing uses an advanced type of diagnostic test that analyzes a small piece of your tumor tissue to determine your biomarker status Patient’s Bill of Rights https://lungevity.org/sites/default/files/nom/NOM-Patients-Bill-of-Rights-041421.pdf Biomarker Testing Quick Facts https://lungevity.org/sites/default/files/nom/NOM-Patients-Bill-of-Rights-041421.pdf 5 Important Things to Know About Your Results Report https://lungevity.org/sites/default/files/nom/NOM-5-Important-Things-to-Know-041421.pdf Biomarker Conversation Starter https://lungevity.org/sites/default/files/biomarker/biomarker-conversation-starter-052020.pdf Find it. Treat it. Live
- 2. LUNGevity Foundation: Lung Cancer Resource Compendium1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 Why Should I Talk to My Doctor About Comprehensive Biomarker Testing? https://lungevity.org/sites/default/files/biomarker/biomarker-flyer-052020.pdf Biomarker Conversation Starter https://lungevity.org/sites/default/files/biomarker/biomarker-conversation-starter-052020.pdf Resources for patients Navigating Lung Cancer: What’s Next? https://lungevity.org/sites/default/files/request-materials/patient-journey-012017.pdf Biomarker Testing for NSCLC Patients https://lungevity.org/sites/default/files/biomarker/biomarker-testing-advice-from-HCPs.pdf LUNGevity provides various one-page resources on biomarker testing for clinicians and patients Resources for healthcare professionals to review with their patients There are comprehensive educational booklets on biomarker testing and targeted therapy from LUNGevity https://lungevity.org/booklets Biomarker Testing Targeted Therapy What is a biomarker? What is biomarker testing? What types of biomarkers are used? Is biomarker testing appropriate for you? For which biomarkers should you be tested? How is biomarker testing performed? Will you need multiple biopsies? What do the results of your biomarker tests mean? Targeted therapy treatments Immunotherapy treatments Approaches to first-line treatment following biomarker testing How does biomarker testing help you enroll in clinical trials? Questions to ask your healthcare team about biomarker testing What is a driver mutation? What are the different types of driver mutations? Driver mutations seen in lung cancers What is targeted therapy? Kinase inhibitors Where do targeted therapies fit into a treatment plan? Driver mutations and their FDA-approved targeted therapies Management of targeted therapy side effects Resistance to tyrosine kinase inhibitors Which driver mutations identified in lung cancer are being studied? Finding a clinical trial that might be right for you Questions to ask your healthcare team about targeted therapy Download educational resources: https//lungevity.org/booklets DNA Mutated genes Cell with non-mutated DNA Cell with multiple DNA mutations May lead to tumor formation
- 3. LUNGevity Foundation: Lung Cancer Resource Compendium1 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 1. https://lungevity.org. A unique patient-to-patient registry Resources to make you feel more connected Survivorship Programs HOPE Summit conferences for lung cancer patients and caregivers Peer-to-Peer Monitoring Support from a fellow survivor or caregiver Lung Cancer HelpLINE Call to talk with an oncology social worker For more information about the support systems available to you in your lung cancer journey, visit the LUNGevity website: https://lungevity.org/for-patients-caregivers/support-services Lung Cancer Support Community A dedicated social network for anyone touched by lung cancer Online Communites Patient TrueTalk
- 4. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 a Approved by the FDA. b NCCN recommendation. c FDA-designated Breakthrough Therapy status. d FDA-designated Fast Track status. ALK Rearrangements Crizotinib,a Ceritinib,a Alectinib,a Brigatinib,a Lorlatinib,a Ensartinib, TPX-0131 BRAF V600E Mutations Dabrafenib + Trametiniba Encorafenib + Binimetinib KRAS G12C Mutations Sotorasiba Adagrasib LY3499446 RET Fusions Selpercatiniba Pralsetiniba Cabozantinibb Vandetanibb TPX-0046 EGFR Exon 20 Mutations Amivantamaba Osimertinib Mobocertinib (TAK-788)c Poziotinib EGFR Mutations Osimertinib,a Afatinib,a Dacomitinib,a Erlotinib,a Gefitiniba Erlotinib + Ramucirumaba Erlotinib + Bevacizumabb Gefitinib + Chemotherapy Osimertinib + Chemotherapy MET Exon 14 Skipping Mutations Capmatiniba Tepotiniba Crizotinibb Savolitinib TPX-0022 HER2 Mutations T-DM1b [Fam-] Trastuzumab Deruxtecanc Poziotinib MAP2K1 AKT1 PIK3CA FGFR3 FGFR2 FGFR1 DDR2 NRAS Clinically Important Genomic Alterations in NSCLC NTRK1 Fusions Larotrectiniba Entrectiniba Selitrectinib Repotrectinib Taletrectinib Merestinib ROS1 Rearrangements Crizotiniba Entrectiniba Ceritinibb Lorlatinibb Repotrectinibd Taletrectinib
- 5. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 ALK rearrangement Brigatinib Vysis ALK Break Apart FISH Probe Kit 90 mg PO QD for 7 d, then 180 mg PO QD (with/without food) 1L metastatic ALK+ NSCLC Ceritinib FoundationOne CDx; VENTANA ALK (D5F3) CDx Assay 450 mg PO QD (with food) 1L metastatic ALK+ NSCLC Crizotinib FoundationOne CDx; VENTANA ALK (D5F3) CDx Assay; Vysis ALK Break Apart FISH Probe Kit 250 mg PO QD 1L metastatic ALK+ NSCLC Alectinib FoundationOne CDx; VENTANA ALK (D5F3) CDx Assay 600 mg PO BID with food 1L (NCCN preferred) metastatic ALK+ NSCLC Lorlatinib N/A 100 mg PO QD 2L metastatic ALK+ NSCLC after PD on alectinib or ceritinib as first ALK inhibitor; 3L metastatic ALK+ NSCLC after PD on crizotinib and ≥1 other ALK inhibitor Molecular Alteration Drug Approved Companion Diagnostic(s) Recommended Dose Approved Indication(s) FDA-Approved Targeted Therapies for NSCLC With Genomic Alterations BRAF V600E mutation Dabrafenib + trametinib FoundationOne CDx; Oncomine Dx Target Test Dabrafenib: 150 mg PO BID (without food); trametinib: 2 mg QD 1L metastatic BRAF V600E mutation–positive NSCLC
- 6. Molecular Alteration Drug Approved Companion Diagnostic(s) Recommended Dose Approved Indication(s) EGFR mutation Dacomitinib Therascreen EGFR RGQ PCR Kit 45 mg PO QD (with/without food) 1L metastatic EGFR exon 19 deletion or exon 21 L858R mutation–positive NSCLC Erlotinib cobas EGFR Mutation Test v2; FoundationOne CDx 150 mg PO QD (on empty stomach) Any line metastatic EGFR exon 19 deletion or exon 21 L858R mutation–positive NSCLC Erlotinib + ramucirumab cobas EGFR Mutation Test v2; FoundationOne CDx Erlotinib: 150 mg PO QD; ramucirumab: 10 mg/kg IV Q2W 1L metastatic EGFR exon 19 deletion or exon 21 L858R mutation–positive NSCLC Afatinib Therascreen EGFR RGQ PCR Kit; FoundationOne CDx 40 mg PO QD 1L metastatic NSCLC, EGFR exon 19 deletion, exon 21 L858R mutations, or other nonresistant EGFR mutations (S768I, L861Q, and/or G719X); 2L metastatic squamous NSCLC after PD on platinum-based chemo Gefitinib Therascreen EGFR RGQ PCR Kit; cobas EGFR Mutation Test v2; FoundationOne CDx 250 mg PO QD (with/without food) 1L metastatic EGFR exon 19 deletion or exon 21 L858R mutation–positive NSCLC Osimertinib FoundationOne CDx; cobas EGFR Mutation Test v2 80 mg PO QD (with/without food) 1L (NCCN preferred) unresectable or metastatic EGFR exon 19 deletion or exon 21 L585R mutation–positive NSCLC; adjuvant treatment after curative resection in EGFR exon 19 deletion or exon 21 L585R mutation; 2L metastatic EGFR T790M mutation– positive NSCLC with PD on or after an EGFR TKI Sotorasib Therascreen KRAS RGQ PCR Kit; Guardant360 CDx 960 mg PO QD (with/without food) KRAS G12C mutation–positive locally advanced or metastatic NSCLC KRAS G12C mutation Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40
- 7. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 Molecular Alteration Drug Approved Companion Diagnostic(s) Recommended Dose Approved Indication(s) NTRK1/2/3 fusion RET fusion MET exon 14 skipping mutation Capmatinib FoundationOne CDx 400 mg PO BID (with/without food) 1L metastatic MET exon 14 skipping mutation–positive NSCLC Selpercatinib N/A <50 kg: 120 mg PO BID; ≥50 kg: 160 mg PO BID 1L metastatic RET fusion–positive NSCLC Pralsetinib Oncomine Dx Target Test 400 mg PO QD 1L metastatic RET fusion–positive NSCLC Entrectinib N/A 600 mg PO QD All lines metastatic NTRK fusion–positive tumors that have no satisfactory alternative treatments or show PD following treatment Larotrectinib N/A 600 mg PO QD All lines metastatic NTRK fusion–positive tumors that have no satisfactory alternative treatments or show PD following treatment ROS1 rearrangement Crizotinib Oncomine Dx Target Test 250 mg PO BID 1L metastatic ROS1-positive NSCLC Entrectinib N/A 600 mg PO QD 1L metastatic ROS1-positive NSCLC Tepotinib N/A 450 mg PO QD (with food) Any line metastatic MET exon 14 skipping mutation–positive NSCLC EGFR exon 20 mutation Amivantamab Guardant360 CDx <80 kg: 1,050 mg ≥80 kg: 1,400 mg IV QW for 4 wk, then Q2W 2L locally advanced or metastatic EGFR exon 20–positive NSCLC with PD on/after platinum-based chemotherapy
- 8. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 Alectinib Adjuvant N/A NCT03456076 (3) TPX-0131 2L, 3L, or 4L N/A FORGE-1/NCT04849273 (1/2) Ensartinib 1L N/A eXalt3/NCT02767804 (3) Encorafenib + binimetinib 1L or 2L N/A PHAROS/NCT03915951 (2) Osimertinib Adjuvant FDA priority review ADAURA/NCT02511106 (3) Gefitinib + chemo 1L N/A NEJ009/UMIN000006340 (3) Erlotinib + bevacizumab 1L NCCN recommendation NEJ1026/UMIN000017069 (3) Osimertinib + ramucirumab 1L N/A TORG1833/CTI-184146 (2) Osimertinib + chemo 1L FLAURA2/NCT04035486 (3) N/A ALK rearrangement BRAF V600E mutation EGFR mutation Investigational Targeted Therapies for NSCLC With Genomic Alterations Target Category Drug Treatment Stage FDA or NCCN Recognition Study ID/Trial Identifier (Phase) Osimertinib Neoadjuvant N/A NCT03433469 (2) Osimertinib ± chemo Neoadjuvant NeoADAURA/NCT04351555 (3) N/A 2L N/A CHRYSALIS/NCT02609776 (2) 2L N/A CHRYSALIS-2/NCT04077463 (1/1b) 1L MARIPOSA/NCT04487080 (3) N/A Lazertinib ± amivantamab ± chemo (multiple studies)
- 9. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 Target Category Drug Treatment Stage FDA or NCCN Recognition Study ID/Trial Identifier (Phase) EGFR exon 20 mutation Amivantamab + chemo 1L N/A PAPILLON/NCT04538664 (3) Poziotinib 2L N/A NCT03066206 (2) Mobocertinib 1L FDA breakthrough TAK-788-3001/NCT04129502 (3) Osimertinib 2L N/A EA5162/NCT03191149 (2) KRAS G12C mutation Sotorasib 2L+ N/A CodeBreak 200/NCT04303780 (3) Adagrasib 1L+ N/A KRYSTAL-1/NCT03785249 (2) HER2 mutation Ado-trastuzumab emtansine 2L+ NCCN recommendation NCT02289833 (2) [Fam-] trastuzumab deruxtecan 2L+ FDA breakthrough DESTINY-Lung01/ NCT03505710 (2) Poziotinib 1L+ NCT03066206 (2) N/A
- 10. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 Target Category Drug Treatment Stage FDA or NCCN Recognition Study ID/Trial Identifier (Phase) MET amplification Cabozantinib 1L+ N/A NCT01639508 (2) Crizotinib Any line NCCN recommendation PROFILE 1001/NCT00585195 (1) Tepotinib 1L+ N/A VISION/NCT02864992 (2) Capmatinib 1L or 2L N/A GEOMETRY/NCT02414139 (2) MET exon 14 skipping mutation Crizotinib Any line NCCN recommendation PROFILE 1001/NCT00585195 (1) TPX-0022 1L+ N/A NCT03993873 (1) Savolitinib 2L+ N/A NCT02897479 (2) NTRK fusion Repotrectinib 1L or 2L FDA fast track TRIDENT-1/NCT03093116 (2) Selitrectinib 1L+ N/A NCT03215511 (2) 2L N/A SAVANNAH/NCT03778229 (2) Merestinib 2L+ N/A NCT02920996 (2) TPX-0022 1L+ N/A NCT03993873 (1) Savolitinib ± osimertinib 1L-3L N/A NCT04606771 (2) Merestinib 2L+ N/A NCT02920996 (2) Taletrectinib 1L+ N/A NCT04617054 (2)
- 11. Genomic Alterations in NSCLC and Approved or Emerging Matched Targeted Therapies1-3 Full abbreviations, accreditation, and disclosure information available at PeerView.com/EYW40 1. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications. 2. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. 3. https://clinicaltrials.gov. Target Category Drug Treatment Stage FDA or NCCN Recognition Study ID/Trial Identifier (Phase) RET rearrangement Cabozantinib 1L+ NCCN recommendation NCT01639508 (2) Vandetanib 2L+ NCCN recommendation NCT01823068 (2) ROS1 rearrangement Ceritinib 1L+ NCCN recommendation NCT01964157 (2) Lorlatinib 2L+ NCCN recommendation NCT01970865 (2) Repotrectinib 1L+ TRIDENT-1/NCT03093116 (2) FDA fast track Selpercatinib 1L+ locally advanced; 1L metastatic N/A LIBRETTO-431/ NCT04194944 (3) Pralsetinib 1L N/A AcceleRET Lung/ NCT04222972 (3) TPX-0046 1L+ SWORD-1/NCT04161391 (1/2) N/A Taletrectinib 1L+ NCT04395677 (2) N/A