GSK reports efficacy of Jemperli in locally advanced rectal cancer study
Phase II trial results indicate that 76% of patients with MSI-H/dMMR locally advanced rectal cancer achieved a complete response using dostarlimab monotherapy.
GSK released interim data from its phase II AZUR-1 trial, which evaluated the immunotherapy drug dostarlimab as a standalone treatment for patients with stage II and III MSI-H/dMMR locally advanced rectal cancer. Clinical assessments found that 76% of evaluable patients achieved a complete response, showing no detectable signs of the disease after treatment.
The current standard of care for this patient population typically involves a combination of chemotherapy, radiation, and surgery. These treatments are often associated with significant long-term side effects, including bowel dysfunction and infertility. The trial results suggest that dostarlimab could serve as an alternative that allows patients to avoid these conventional, invasive procedures.
Lead investigator Dr. Andrea Cercek noted that the absence of disease recurrence after more than two years of follow-up provides a strong basis for organ preservation approaches. Regarding safety, 20% of patients reported serious adverse reactions, with fatigue and rash being the most frequent, consistent with the known safety profile of the drug in other solid tumor treatments.
GSK will present the full study findings at the upcoming European Society for Medical Oncology (ESMO) Congress. Following US approval for this indication, the company is continuing regulatory discussions globally through the Project Orbis initiative.