a randomized phase 2 trial comparing efficacy of the combination of the parp-inhibitor olaparib and...

17
A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone in Recurrent Platinum-sensitive Ovarian Cancer Presented By Joyce Liu at 2014 ASCO Annual Meeting

Upload: sherman-elliott

Post on 14-Dec-2015

216 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone in Recurrent Platinum-sensitive Ovarian Cancer

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 2: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Background: cediranib and olaparib are active agents in ovarian cancer

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 3: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Cediranib and olaparib have synergistic activity in vitro

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 4: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Phase 1 study of cediranib and olaparib demonstrated activity in ovarian cancer patients

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 5: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Study Objectives

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 6: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Study Design

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 7: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Key eligibility criteria

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 8: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Statistical Considerations

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 9: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Study Status and Data Analysis

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 10: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Patient Characteristics

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 11: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Primary Outcome: Cediranib/olaparib significantly increased PFS compared to olaparib alone

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 12: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Secondary Outcome: Cediranib/olaparib significantly increased overall response rate (ORR) compared to olaparib alone

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 13: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Cediranib/olaparib significantly increased PFS in patients without a BRCA mutation

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 14: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Treatment-related Adverse Events

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 15: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Tolerability of cediranib/olaparib combination

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 16: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Conclusions

Presented By Joyce Liu at 2014 ASCO Annual Meeting

Page 17: A Randomized Phase 2 Trial Comparing Efficacy of the Combination of the PARP-inhibitor Olaparib and the Anti-angiogenic Cediranib Against Olaparib Alone

Acknowledgments

Presented By Joyce Liu at 2014 ASCO Annual Meeting