Alex Ramsey's questions to Revolution Medicines Inc (RVMD) leadership • Q4 2024
Question
Alex Ramsey, on behalf of Peter Lawson at Barclays, asked about the timeline for completing the second-line PDAC study (RASolute 302) and how a potential approval could impact the control arm of the first-line trial. He also asked about the possibility of an accelerated approval.
Answer
CEO Dr. Mark Goldsmith expressed high confidence in substantially completing enrollment for the second-line trial in 2025, acknowledging this creates pressure to finalize the first-line trial design, which they aim to initiate by year-end. Regarding accelerated approval, he stated they do not assume it's a viable path in PDAC, as the FDA is generally not supportive given the short interval between PFS and OS readouts. The trial is powered for OS.