publication date: Sep. 20, 2019

Drugs & Targets

FDA approves Keytruda + Lenvima for advanced endometrial carcinoma

FDA has granted accelerated approval to the combination of Merck’s Keytruda (pembrolizumab) plus Esai’s Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

FDA, The Australian Therapeutic Goods Administration, and Health Canada collaborated on this review, which allowed for simultaneous decisions on the combination in all three countries.

Efficacy was investigated in study 111/KEYNOTE-146 (NCT02501096), a single-arm, multicenter, open-label, multi-cohort trial that enrolled 108 patients with metastatic endometrial carcinoma that had progressed following at least one prior systemic therapy in any setting. Patients were treated with lenvatinib 20 mg orally once daily in combination with pembrolizumab 200 mg administered intravenously every three weeks until unacceptable toxicity or disease progression.

Among the 108 patients, 94 had tumors that were not MSI-H or dMMR, 11 had tumors that were MSI-H or dMMR, and in three patients the tumor MSI-H or dMMR status was not known. Tumor MSI status was determined using a polymerase chain reaction test. Tumor MMR status was determined using an immunohistochemistry test.

The major efficacy outcome measures were objective response rate (ORR) and duration of response by independent radiologic review committee using RECIST 1.1. The ORR in the 94 patients whose tumors were not MSI-H or dMMR was 38.3% (95% CI: 29%, 49%) with 10 complete responses (10.6%) and 26 partial responses (27.7%), or shrinkage of lesions by at least 30%. Median DOR was not reached at the time of data cutoff and 25 patients … Continue reading FDA approves Keytruda + Lenvima for advanced endometrial carcinoma

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