Merck announced the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This sBLA is based in part on data from the pivotal Phase 3 KEYNOTE-048 trial where KEYTRUDA demonstrated a significant improvement in overall survival compared with the standard of care, as monotherapy in patients whose tumors expressed PD-L1 with CPS≥20 and CPS≥1 and in combination with chemotherapy in the total patient population. These data were presented at the European Society for Medical Oncology 2018 Congress. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2019.
“Head and neck cancer remains a challenging and devastating disease, and newly diagnosed patients are in need of improved treatment options,” said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. “Merck continues to make meaningful advances in the treatment of head and neck cancer, and we look forward to working with the FDA to bring these important new options to patients in the first-line setting.”
KEYNOTE-048 also serves as the confirmatory trial for KEYNOTE-012, a Phase 1b study which supported the previous accelerated approval for KEYTRUDA as monotherapy for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
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Merck currently has the largest immuno-oncology clinical development program in HNSCC and is continuing to advance multiple registration-enabling studies investigating KEYTRUDA as monotherapy and in combination with other cancer treatments—including KEYNOTE-412, KEYNOTE-689 and KEYNOTE-122.
KEYNOTE-048, a randomized, open-label Phase 3 trial evaluated KEYTRUDA monotherapy or KEYTRUDA combination, compared with the EXTREME regimen, as first-line treatment in 882 patients with recurrent or metastatic HSNCC. The dual primary endpoints were OS and PFS. The secondary endpoints were PFS (at 6 months and 12 months), objective response rate (ORR) and time to deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and Safety. Duration of response (DOR) was evaluated as part of a pre-specified exploratory analysis. The primary and secondary endpoints, as well as exploratory DOR analysis, were evaluated in patients whose tumors expressed PD-L1 with CPS ≥20 and CPS ≥1, and in the total population, regardless of PD-L1 expression, based on a fixed sequential testing strategy. At the time of the analysis, the median follow-up was 11.7 months for KEYTRUDA monotherapy, 13.0 months for KEYTRUDA combination and 10.7 months for the EXTREME regimen, respectively.