Release Date: March 04, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you confirm whether rilvegostomig will be included in AstraZeneca's Phase 3 study design for the B7-H4 DCPSAM? A: Anat Cohen-Dayag, President and CEO, stated that they cannot comment on anything not publicly disclosed by AstraZeneca. However, they are pleased with the progress of the seven pivotal trials AstraZeneca has initiated, which include testing rilvegostomig in various combinations.
Q: Can we expect any near-term data from AstraZeneca that could clarify the contribution to efficacy for the TIGIT part? A: Anat Cohen-Dayag mentioned that AstraZeneca plans to present data in 2025 from the combination of rilvegostomig with ADCs. Previous data from rilvegostomig in non-small cell lung cancer and gastric cancer have shown promising efficacy and safety profiles.
Q: What is the design of the ovarian study, and how is it powered to show PFS hazard ratio? A: Michelle Mahler, Chief Medical Officer, explained that the study is an exploratory Phase 1B study, not powered for a full pivotal trial. It uses Bayesian statistics to evaluate the probability of a more than three-month improvement in progression-free survival (PFS) compared to placebo.
Q: Is there interest in evaluating GS-0321 in hematologic malignancies, possibly in combination with rituximab? A: Eran Ophir, VP of Research, stated that while hematological applications are interesting, the current focus is on solid tumors where they have observed unique activity in the tumor microenvironment.
Q: What triggers the interim analysis in the platinum-sensitive ovarian cancer study, and is there a predefined futility threshold? A: Michelle Mahler explained that the interim analysis is triggered by a combination of event rate and follow-up duration. There is a futility boundary, and Bayesian statistics will be used to assess the probability of a three-month improvement in PFS.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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