- The FDA’s Oncologic Drugs Advisory Committee backed GSK plc’s GSK proposed single-arm trials to gain accelerated approval of its PD-1 inhibitor Jemperli in a rare subtype of locally advanced rectal cancer.
- The Advisory Committee voted 8-5 to support GSK’s proposal, which includes a single-arm trial of mismatch repair-deficient (MMR-deficient) or microsatellite instability-high (MSI-H) rectal cancer.
- The proposed overall clinical development program will consist of two single-arm trials, including:
- A single-center trial that will enroll 30 patients
- A proposed multicenter trial that will enroll 100 patients.
- Related: FDA Grants Complete Approval For GSK’s Jemperli For Endometrial Cancer.
- GSK is initiating a global, open-label, phase 2 trial to investigate the efficacy and safety of dostarlimab-gxly as monotherapy – as a replacement for chemotherapy, radiation and/or surgery – for treatment-naïve patients with dMMR/MSI-H locally advanced rectal cancer.
- In September 2022, FDA and GSK held a Type B meeting.
- The FDA expressed concerns regarding some elements of the proposed strategy to support accelerated approval and verify clinical benefits, including:
- Adequacy of data derived from a small cohort of patients from two single-arm trials to support approval.
- The proposed and unprecedented use of cCR12 as an endpoint for accelerated approval.
- Data package proposed to verify clinical benefit, including the role of a proposed study in patients with colon cancer.
- Price Action: GSK shares are down 1.19% at $36.00 on the last check Friday.
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