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FDA Grants Breakthrough Therapy Designation to GSK’s Jemperli for dMMR/MSI-H Rectal Cancer

NextEdge Admin

17 Dec 2024

2 min 21 sec

GSK plc announced that the US FDA has granted Breakthrough Therapy Designation for Jemperli (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. This designation recognizes the potential for substantial improvement in treating serious conditions and builds on a prior Fast Track designation from January 2023.

The designation is supported by results from a GSK-supported phase II trial with Memorial Sloan Kettering Cancer Center, showing an unprecedented 100% clinical complete response (cCR) in 42 patients treated with dostarlimab. cCR, defined as no evidence of tumors assessed by imaging, endoscopy, PET scan, and rectal exam, was sustained in the first 24 patients with a median follow-up of 26.3 months. Dostarlimab’s safety profile was consistent with prior data, with no grade 3 or higher adverse events reported.

The ongoing phase II AZUR-1 registrational trial aims to confirm these findings. Current standard care for dMMR/MSI-H rectal cancer includes chemoradiotherapy and surgery, which can lead to significant long-term quality-of-life issues, such as bowel, urinary, and sexual dysfunction, secondary cancers, and infertility.

Dostarlimab, a PD-1-blocking antibody, is a key component of GSK’s immuno-oncology research program, with studies spanning gynecologic, colorectal, and other cancers. While approved for endometrial and advanced dMMR solid tumors, dostarlimab is not yet approved for frontline treatment of dMMR/MSI-H rectal cancer.

Colorectal cancer remains the third most diagnosed cancer globally, with approximately 5-10% of rectal cancers being dMMR/MSI-H.