FDA Grants Priority Review to Keytruda to Treat Non-Small Cell Lung Cancer Subgroup

The Food and Drug Administration (FDA) granted priority review to Keytruda (pembrolizumab) monotherapy for the first-line treatment of patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

“Keytruda is already a foundation for the treatment of metastatic non-small cell lung cancer,” Roy Baynes, M.D., Ph.D., senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in a statement.

“We are pleased that the FDA is reviewing this (supplemental biologics license application) and we look forward to potentially extending the monotherapy indication for Keytruda to locally advanced or metastatic patients whose tumors express PD-L1, with a tumor proportion score of one percent or more,” he added.

The new supplemental biologics license application included data from the pivotal Phase 3 KEYNOTE-042 trial — one of three trials designed to demonstrate a significant improvement in overall survival – which were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

In the trial, those treated with frontline Keytruda lived 4 to 8 months longer than those who received standard of care chemotherapy, depending on their level of PD-L1 expression.

In addition, improved overall survival was correlated with greater levels of PD-L1 expression: Tumor proportion score (TPS) of 50 percent or more (20 vs. 12.2 months), TPS of 20 percent or more (17.7 vs. 13 months) and TPS of 1 percent or more (16.7 vs. 12.1 months) compared with chemotherapy. Across all patients with PD-L1 TPS of 1 percent to 49 percent, the median overall survival was 13.4 months with Keytruda compared with 12.1 months for chemotherapy.

“We do need to do a lot more work,” said lead study author Gilberto Lopes, M.D., MBA, a medical oncologist at the Sylvester Comprehensive Cancer Center ay University of Miami Health System in Florida, during his presentation at ASCO.

“Even though patients do better today, they still do not do well enough,” he added. “The vast majority of patients with advanced lung cancer will have disease progression and will succumb to lung cancer. So, we need to continue doing more work.”

The FDA set a target action date for Jan. 11, 2019.