Merck application for Keytruda plus Padcev for Urothelial Cancer gets USFDA priority review

KEYTRUDA plus enfortumab vedotin also achieved a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 55% (median PFS, 12.5 months vs. 6.3 months, respectively); (HR=0.45 [95% CI, 0.38-0.54]; p<0.00001). Results were consistent across all pre-defined subgroups, including patients who may or may not be eligible for treatment with cisplatin-based chemotherapy as well as patients whose tumors expressed both high (Combined Positive Score [CPS] ≥10) or low (CPS <10) levels of PD-L1, and patients with or without liver metastases.

“The FDA’s acceptance of this application for priority review, as well as under the RTOR program, underscores the urgency to bring this treatment option that has demonstrated an OS benefit over chemotherapy to more patients with locally advanced or metastatic urothelial carcinoma,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working closely with the FDA to provide this important option to patients as quickly as possible.”

The KEYNOTE-A39 trial is intended to serve as the basis for global regulatory submissions for the treatment of adult patients with la/mUC and as the confirmatory trial for the current U.S. accelerated approval of KEYTRUDA plus enfortumab vedotin for adult patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy. The accelerated approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K.

Merck, in collaboration with Seagen and Astellas, are evaluating this combination as part of an extensive clinical development program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in muscle-invasive bladder cancer in KEYNOTE-B15 (NCT04700124, also known as EV-304) and KEYNOTE-905 (NCT03924895, also known as EV-303).