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# GSK’s Jemperli Trial Meets Endpoint in Rectal Cancer
- URL: https://www.fdaweb.com/gsks-jemperli-trial-meets-endpoint-in-rectal-cancer/
- Published: 2026-07-13T12:00:00.000Z
- Updated: 2026-09-14T13:42:45.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5161447

GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, paving the way for regulatory submissions that could establish the drug as the first immunotherapy to allow some patients to avoid chemotherapy, radiation and surgery.

The company says interim results from the single-arm AZUR-1 trial demonstrated a sustained clinical complete response at 12 months (cCR12), meaning patients had no detectable signs of cancer for at least one year after treatment. GSK notes the findings support the potential for dostarlimab monotherapy to eliminate or delay the need for standard multimodal treatment, which typically includes chemotherapy, radiation therapy and surgery for patients with stage II/III rectal cancer.

The registrational study enrolled 154 patients with stage II/III dMMR/MSI-H locally advanced rectal cancer, a molecular subtype that accounts for an estimated 5% to 10% of rectal cancers. Participants received nine cycles of dostarlimab administered every three weeks over six months. The trial builds on earlier research conducted with Memorial Sloan Kettering Cancer Center, which first generated widespread attention after reporting complete clinical responses in a small cohort of patients treated with dostarlimab alone.

GSK says the interim AZUR-1 results represent a substantial improvement over historical outcomes with standard therapy. The company did not disclose detailed efficacy data or the exact clinical complete response rate, saying the full results will be presented at a future scientific meeting.

According to the company, the safety profile observed in AZUR-1 was consistent with the established safety profile of dostarlimab across solid tumors, with no new safety signals identified.

Jemperli is currently approved for several gynecologic cancers and other solid tumors with mismatch repair deficiency but has not been approved in any country for the treatment of rectal cancer.