CPHI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Home Policy & Regulation News Merck's Keytruda scores another FDA approval
News
11 May 2017

Merck's Keytruda scores another FDA approval

FDA approves Keytruda as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

The FDA has approved Merck's (MSD's) Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

The approval was based on data from KEYNOTE-021, Cohort G1, in 123 previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations and irrespective of PD-L1 expression. In this trial, Keytruda + pem/carbo demonstrated an objective response rate (ORR) that was nearly double the ORR of pem/carbo alone (55% compared to 29%, respectively; all responses were partial responses).

Among patients who received Keytruda + pem/carbo, 93% had a duration of response of 6 months or more compared with 81% who received pem/carbo alone. In addition, findings demonstrated an improvement in PFS, with a median PFS of 13.0 months for patients treated with Keytruda + pem/carbo compared to 8.9 months with pem/carbo alone.

“The improved responses seen with the Keytruda + pemetrexed/carboplatin regimen are significant, and highlight the importance of finding new approaches that address the unmet needs of patients with metastatic nonsquamous NSCLC,” said Dr Roger M. Perlmutter, president, Merck Research Laboratories. “Today’s approval further supports our commitment to improve the lives of people with cancer.”

“This approval marks an important milestone in the treatment of lung cancer. Now, pembrolizumab in combination with pemetrexed and carboplatin can be prescribed in the first-line

  • setting for patients with metastatic nonsquamous NSCLC, irrespective of PD-L1 expression,” said Dr Corey Langer, director of thoracic oncology and professor of medicine at the Hospital of the University of Pennsylvania. “Physicians should continue to use each patient’s individual characteristics – including biomarker status, histology, and other clinical factors – to determine the best treatment plan for each person.”

    “The combination of this immunotherapy with pemetrexed and carboplatin is more good news for patients,” said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation. “Congratulations to Merck and the FDA for moving so swiftly on this important addition to our patients’ options for treatment. With this approval, hope for lung cancer patients continues to improve.”

    • Related tags
    Policy & Regulation Research & Development

    Related News