12/29/2023 0 Comments Keynote 158 trial![]() ![]() Of note, the trials excluded patients with autoimmune disease or a medical condition that required immunosuppression. For pediatric patients the dose was 2 mg/kg every 3 weeks. The administration of pembrolizumab for adult patients was 200 mg intravenously every 3 weeks until unacceptable toxicity, disease progression, or a maximum of 2 years. In terms of exposure to the therapy, the median duration of exposure was 6.2 months (range, 1 day to 53.5 months) in KEYNOTE-158 and KEYNOTE-164 and was 2.1 months (range, 1 day to 25 months) in KEYNOTE-051. Supporting the approval of all other tumor types beyond CRC, the collective ORR was 33% (95% CI, 28%-38%) with a DOR ranging from 1.9 months to ongoing at 63.9 months. The expanded indication adds to the FDA approval of pembrolizumab for the treatment of patients with dMMR/MSI-H advanced endometrial cancer based on data from KEYNOTE-158, granted in March of 2022. 1 In 2020, pembrolizumab was approved for the frontline treatment of this patient population based on data from the KEYNOTE-177 trial (NCT02563002). The duration of response ranged from 4.4 months to ongoing responses observed at 58.5 months. Among responders the median duration of response (DOR) was 63.2 months with 77% of responders having a response lasting at least 12 months and 39% having a response that lasted at least 36 months. This included a complete response rate of 10.3% and a partial response rate of 23.0%. In a pooled analysis of 504 patients from the 3 trials, at a median follow-up of 20.1 months (range, 0.1-71.4), the objective response rate (ORR) was 33.3% (95% CI, 29.2%-37.6%). At the same time, the agent was also approved for patients with dMMR/MSI-H CRC that had progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. In May 2017, the FDA granted accelerated approval to the PD-1 inhibitor for the same indication, marking the first tumor agnostic approval from the agency. The approval is based on data from KEYNOTE-158 (NCT02628067), which evaluated the agent in advanced solid tumors, KEYNOTE-164 (NCT02460198), which evaluated the agent in patients with previously treated, locally advanced unresectable or metastatic colorectal cancer (CRC), and KEYNOTE-051 (NCT02332668), which evaluated pediatric patients with advanced solid tumors or lymphoma. dMMR and MSI-H status must be confirmed by an FDA-approved test according to the indication. The FDA has granted full regular approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable mismatch repair deficient (dMMR) or microsatellite instability-high tumors (MSI-H) tumors who have disease progression on prior treatment and for whom other satisfactory treatment options do not exist.
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