Slide 1: AACR 2014 Analyst Briefing
AACR 2014 Analyst Briefing April 6, 2014 1
Slide 2: Forward Looking Statements
Forward Looking Statements • Our discussions during this meeting will include forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements. • The factors that could cause actual results to differ are discussed in Pfizer’s 2013 Annual Repor
Slide 3: Garry Nicholson, President, Pfizer Oncology
Garry Nicholson President Pfizer Oncology 3
Slide 4: Pfizer Oncology: Focused Execution Grows Franchise
Pfizer Oncology: Focused Execution Grows Franchise Pfizer Oncology Mission: To Cure and Control Cancer with Innovative Medicines Inline Phase 1/2 Pipeline Highlights Phase 3 Pipeline Portfolio PF 06463922 PF 04449913 Palbociclib ALK/ROS1 SMO inhibitor CDK 4/6 inhibitor Inhibitor PF 03084014 PF 05082
Slide 5: Dr. Mace Rothenberg, Chief Medical Officer, Pfizer Oncology
Dr. Mace Rothenberg Senior Vice President, Clinical Development and Medical Affairs, Chief Medical Officer Pfizer Oncology 5
Slide 6: Final Results of a Randomized Phase 2 Study of Palbociclib (PALOMA-1)
Final Results of a Randomized Phase 2 Study of Palbociclib (PD 0332991) a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor, in Combination with Letrozole vs Letrozole Alone for First-Line Treatment of ER+, HER2– Advanced Breast Cancer (PALOMA-1/TRIO-18) RS FINN,1 JP CROWN,2 I LANG,3 K BOER,4 IM BONDARENK
Slide 7: Final PALOMA-1 Progression-Free Survival Results
Final PALOMA-1 Progression-Free Survival Results Palbociclib + letrozole significantly prolonged progression-free survival (PFS) in patients with ER+, HER2- advanced breast cancer versus letrozole alone. Median PFS = 20.2 months P+L v. 10.2 months L alone, p=0.0004, HR=0.488 • Statistically signific
Slide 8: Best Overall Response (ITT)
Best Overall Response (ITT) Objective Response Rate, Clinical Benefit Rate Confirm the Meaningful Treatment Effect Demonstrated with PFS Objective RR = 43% for P+L arm vs 33% for L alone Clinical Benefit rate = 81% for P+L vs 58% for L alone 8
Slide 9: Initial PALOMA-1 Overall Survival (OS) Analysis
Initial PALOMA-1 Overall Survival (OS) Analysis Per the PALOMA-1 protocol, OS, a secondary endpoint, was assessed in an initial analysis at the time of PFS final analysis. Initial assessment was not significant (Median OS of 37.5 months for P+L compared to 33.3 months for L alone, HR = 0.813, 95% CI
Slide 10: Most Common All-Causality Adverse Events
Most Common All-Causality Adverse Events The combination of palbociclib and letrozole was generally well- tolerated and the safety profile of the combination was consistent with previously reported data. The most common AEs in P + L arm: neutropenia, leukopenia, fatigue and anemia. • The neutropenia
Slide 11: Conclusion: How Meaningful Are These Data?
Conclusion: How Meaningful Are These Data? • The magnitude of benefit • The number of women impacted • The novel MOA and insights into the underlying biology • We are the first to this point • The future potential in breast cancer and beyond 11
Slide 12: Palbociclib Development in ER+/HER2- Breast Cancer
Palbociclib Development in ER+/HER2- Breast Cancer Low Risk Intermediate Risk High Risk Population Population Population Invasive Neo Early BC Adjuvant Collaborative Investigator Initiated Research (Stages I-III) Adjuvant Metastatic 1st Line PALOMA-2 (Ph. 3) Letrozole + Palbociclib or placebo BC (St
Slide 13: Q&A
Q&A 13