LONDON – GSK plc (LSE/NYSE: GSK) announced that Jemperli (dostarlimab) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced mismatch repair deficiency (dMMR)/microtunnel instability. Small industrial-height rectal cancer (MSI-H). The classification is based on clinical data showing a 100% complete clinical response rate in all 42 patients who completed treatment in the ongoing phase 2 trial.
The FDA's Breakthrough Therapy Designation is intended to accelerate the development and review of drugs that may offer significant improvements over current treatments for serious conditions. Dostarlimab, an antibody that blocks the programmed death 1 (PD-1) receptor, received Fast Track designation for the same patient population in January 2023.
The current standard of care for dMMR/MSI-H locally advanced rectal cancer includes chemotherapy, radiation, and surgery, which may lead to long-term adverse effects on quality of life. Promising results from this phase II trial suggest that dostarlimab could change the treatment paradigm for these patients.
The trial, conducted in collaboration with Memorial Sloan Kettering Cancer Center, showed that all patients who completed treatment with dostarlimab had no evidence of disease, as assessed by various imaging and medical examination techniques. A sustained complete clinical response was observed in the first 24 patients evaluated, with a median follow-up of 26.3 months. The safety profile of the treatment was consistent with known information, with no grade 3 or higher adverse events reported.
While Jemperli is not yet approved for the treatment of locally advanced dMMR/MSI-H rectal cancer, it is currently indicated in the United States for some patients with advanced or recurrent endometrial cancer and for those with recurrent or advanced solid tumors dMMR under approval Fast.
GSK's ongoing Phase 2 registration trial AZUR-1 aims to confirm the results of the current study. The company is also exploring Jemperli in an aggressive clinical trial program for various cancers, including gynecological, colorectal and lung cancers.
This breakthrough designation underscores the potential of dostarlimab in providing a new treatment option for patients with locally advanced dMMR/MSI-H rectal cancer, a subgroup of colorectal cancer that is particularly difficult to treat. The information in this article is based on a GSK press release.
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