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3 Promising CDK 4/6 Inhibiting Breast Cancer Drugs
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3 Promising CDK 4/6 Inhibiting Breast Cancer Drugs

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CDK 4/6 Inhibitor breast cancer drugs from Pfizer (PFE), Novartis (NVS) and Lilly (LLY) are making their way through trials and may soon give patients and doctors a new, important weapon in HER2 …

CDK 4/6 Inhibitor breast cancer drugs from Pfizer (PFE), Novartis (NVS) and Lilly (LLY) are making their way through trials and may soon give patients and doctors a new, important weapon in HER2 positive breast cancer.

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  • 1. 3 Promising Breast Cancer Treatments
  • 2. What is CDK 4/6? • CDK 4/6 helps control cell creation. They are key regulators of the cycle that helps cells progress from growth to DNA replication. In patients with estrogen receptor positive, or ER+, breast cancer, CDK 4/6 is often over- active. Slowing activity of CDK 4/6 may help breast cancer patients
  • 3. Pfizer: Palbociclib • Targets CDK 4/6 to inhibit its activity • Two Phase 3 studies of palbociclib in advanced/metastatic breast cancer. – Combined with letrozole versus letrozole plus placebo as a first-line treatment for post-menopausal patients with ER+, HER2- advanced breast cancer. – Combined with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, or HR+, HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy. Phase 3 tests are underway
  • 4. Pfizer: Palbociclib • Significantly delayed disease progression, or PFS, in post- menopausal women with ER+, HER2- locally advanced or metastatic breast cancer when combined with letrozole versus letrozole and placebo. – Median PFS was 20.2 months versus 10.2 months for letrozole alone. – Overall survival was 37.5 months versus 33.3 months for letrozole alone. Phase 2 results were solid
  • 5. Novartis: LEE011 • Targets CDK 4/6 to inhibit its activity – A phase Ib/II study of LEE011 in postmenopausal women with HER2- locally recurrent or advanced metastatic breast cancer. – A phase Ib/II study of LEE011 in patients with advanced ER+ breast cancer. – A phase Ib/II study of LEE011 in postmenopausal women with ER+, HER2- locally advanced or metastatic breast cancer. – A phase 3 study of LEE011 combined with letrozole for postmenopausal women with HER2- advanced breast cancer who received no prior therapy for advanced disease. Source: Clinicaltrials.gov Phase 1/2 & 3 trials underway
  • 6. Novartis: LEE011 • Novartis hasn’t publicly detailed human trial data for LEE011 yet, but has given very preliminary preclinical insight of LEE011 efficacy in mice. – Tumor growth was halted in mice treated with LEE011 in each of four ER+ xenograft models. – Adding letrozole or fulvestrant to LEE011 treatment regimen further improved results. – Complete tumor regressions were observed for a subset of mice within each of the triple combination arms and continued for up to four weeks after treatment without significant toxicities. Pre-clinical results only
  • 7. Eli Lilly: LY2835210 • Targets CDK 4/6 to inhibit its activity – A phase 1b Study of LY2835219 in patients with HER2- metastatic breast cancer (currently enrolling patients). – A phase 2 study of LY2835219 in patients with previously treated HER2- metastatic breast cancer (enrollment begins in May). – A phase 3 Study of fulvestrant with or without LY2835219, in patients with HER2- locally advanced or metastatic breast cancer (enrollment begins in July). Source: Clinicaltrials.gov Phase 1, 2, & 3 trials underway or approaching
  • 8. Eli Lilly: LY2835210 • Eli Lilly presented phase 1 results during last week’s Association for Cancer Research meeting showing anti-tumor activity for LY2835210 in HR+ metastatic breast cancer patients, a population that makes up 80% of all breast cancer cases. – 25% of HR+ patients (9 out of 36) treated with LY2835210 responded to the therapy. – Disease progression was delayed by 9.1 months. Phase 1 results only
  • 9. Advancing to the FDA – Pfizer’s palbociclib has the early edge for getting an FDA yay or nay. Pfizer already has compelling phase 2 data in hand that some analysts hope may allow it to file for a conditional or rolling FDA approval. That may be optimistic. However, investors should keep an eye out to see if Pfizer mentions such a filing in its Q1 earnings conference call. – Novartis and Lilly are both racing to catch up to Pfizer. Novartis began its phase 3 trial in December and Lilly will begin enrolling patients in July. That means all three will have phase 3 trials underway by fall and investors could learn more about the drug developers timeline for the compounds by year end. When will these drugs arrive?
  • 10. 6 stock picks poised for incredible growth

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