Moderator of 2 Sessions
Session Description:
Supporter Statement:Supported by an independent educational grant from AstraZeneca Pharmaceuticals LP; Merck & Co., Inc; GlaxoSmithKline
Partner Statement:Developed through a collaboration between The GOG Foundation, Inc. and Medscape Oncology
This 90-minute lunch symposium will feature expert faculty guiding clinicians through patient case challenges focusing on areas of controversy in advanced ovarian cancer. The patient case challenges will allow for extensive audience engagement, and faculty will provide clinical guidance and feedback at key decision points. Please come with your most pressing questions.
Presenter of 13 Presentations
Concluding remarks
Defining platinum base therapy that is no longer an option for patients
Q&A/Discussion
Welcome and Introduction
• Potential impact on standard of care: Review of pending trials - Analysis
Panel Discussion and Audience Q&A
Panel Discussion
- Robert L Coleman (United States of America)
- Paul A. DiSilvestro (United States of America)
- Antonio Gonzalez-Martin (Spain)
- Thomas J. Herzog (United States of America)
- Mansoor R. Mirza (Denmark)
- Bradley J. Monk (United States of America)
- Kathleen N. Moore (United States of America)
- Amit Oza (Canada)
- Isabelle L. Ray-Coquard (France)
- Brian M. Slomovitz (United States of America)
- Jonathan A. Ledermann (United Kingdom)
Q&A/Discussion
Group Discussion: Impact of PARP Inhibitors on subsequent therapies
Closing Comments
Consensus or Controversy? Endpoints in Trials of PARP Inhibitors in Advanced Ovarian Cancer
DURVALUMAB, IN COMBINATION WITH AND FOLLOWING CHEMORADIOTHERAPY, IN LOCALLY ADVANCED CERVICAL CANCER: RESULTS FROM THE PHASE 3 INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CALLA TRIAL
Abstract
Objectives
In locally-advanced cervical cancer (LACC), platinum-based chemoradiotherapy (CRT) has been the standard- of-care treatment for >20 years. CALLA is the first global Phase 3 study evaluating immune checkpoint inhibition (durvalumab) versus placebo in combination with and following CRT in LACC (NCT03830866).
Methods
Newly-diagnosed, untreated patients with LACC (FIGO 2009 stages IB2–IIB node positive, IIIA–IVA with any node status) were randomized 1:1 to durvalumab (1500 mg IV) or placebo Q4W, for a total of up to 24 months, in combination with and following CRT. CRT comprised concurrent weekly IV cisplatin with EBRT and brachytherapy. RT quality was monitored, with variations evaluated for clinical significance. The primary endpoint is PFS; secondary endpoints include OS, objective response rate, local/distant disease progression incidence, and safety.
Results
770 patients were randomized (N=385 per arm) at 120 sites in 15 countries. Median age was 49 years; median follow-up was 18.5 months.
Durvalumab+CRT did not show a statistically significant improvement in PFS vs placebo+CRT (HR 0.84 [95% CI, 0.65-1.08]; P=0.174); there was no detriment to OS, although data were immature and not formally tested.
Adverse events of grade 3–4 occurred in 51.7% and 51.0% of patients in the durvalumab+CRT and placebo+CRT arms, respectively; 12.5% and 9.6% of patients discontinued treatment due to AEs possibly related to study drug.
Conclusions
Durvalumab in combination with and following CRT did not significantly improve PFS in patients with LACC. Safety of durvalumab+CRT was generally comparable to CRT alone, with no new or unexpected toxicity.
Funding: AstraZeneca