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Friday, December 02, 2016

FDA Grants Priority Review to Pembrolizumab for MSI-H Cancer (including non-CRC)

FDA Grants Priority Review to Pembrolizumab for MSI-H Cancer

 In the 3-arm study that was the basis for the new designation, pembrolizumab was administered at 10 mg/kg every 2 weeks to patients with CRC who were MMR-deficient (n = 13) and MMR-proficient (n = 25). Additionally, a separate arm looked at pembrolizumab in patients with MMR-deficient non-CRC malignancies (n = 10). MMR and microsatellite instability testing was conducted using PCR and IHC, which are standard tests conducted for patients with CRC in order to detect Lynch syndrome.

 In the 48 patients analyzed from the study for the ASCO presentation, those with MMR-deficient CRC experienced a DCR of 92% compared with 16% in MMR-proficient tumors. After a median treatment duration of 5.9 months, no patients in the MMR-deficient group who responded had progressed. In patients with MMR-deficient non-CRC tumors, the ORR was 60% and the DCR was 70%.
OS and PFS were not reached in the MMR-deficient group versus a median PFS of 2.3 months (HR, 0.10; 95% CI, 0.03-0.37; P <.001) and an OS of 7.6 months in the MMR-proficient group (HR, 0.22; 95% CI, 0.05-1.00; P = .05)......

 The phase II study enrolled 3 patient cohorts. The first 2 cohorts were patients with CRC, while the third cohort included 21 patients with any solid gastrointestinal tumor that had mismatch repair deficiency.

...This Data from 17 patients with non-CRC GI cancers deficient in mismatch repair were available for analysis: 4 patients with ampullary cancer, 4 with pancreatic cancer, 3 with biliary cancer, 3 with small bowel cancer, and 3 with gastric cancer. Their median age was 60 years; 29% were female, 29% had an ECOG performance score of 0, and 100% had metastatic disease. The median number of prior regimens was 2.cohort was subsequently expanded by 50 patients.....Clinical benefit was observed across tumors with mismatch repair deficiency including cancers of the colon, stomach, duodenum, pancreas, ampulla, and bile ducts.


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