Merck & Co. seeks FDA approval of Keytruda as first-line treatment for squamous NSCLC

Merck & Co. disclosed Thursday that it recently filed an application with the FDA seeking approval of Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic squamous non-small-cell lung cancer (NSCLC). The company noted that the submission is based on an interim analysis of the KEYNOTE-407 study.

According to Merck, the trial met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of patients, without providing further details. The study is investigating Keytruda in combination with carboplatin-paclitaxel or Celgene's Abraxane (nab-paclitaxel), compared with carboplatin-paclitaxel or Abraxane alone, in 560 untreated patients with metastatic squamous NSCLC. 

Merck noted that the trial's dual primary endpoints are overall survival and progression-free survival, while secondary goals include ORR and duration of response. Results from the study are scheduled to be presented at the American Society of Clinical Oncology (ASCO) annual meeting, with the drugmaker indicating that an additional interim analysis will be conducted prior to the conference. 

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Earlier this week, Merck announced that Keytruda has been granted priority review by the FDA in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy as a first-line treatment for patients with metastatic non-squamous NSCLC. Meanwhile, the anti-PD-1 therapy gained accelerated approval last year in combination with Alimta and carboplatin in previously untreated patients with metastatic non-squamous NSCLC irrespective of PD-L1 expression. Merck recently revealed that first-quarter sales of the product nearly tripled year-over-year to $1.5 billion.

In March, Roche announced Phase III study results demonstrating that the combination of Tecentriq (atezolizumab) plus chemotherapy reduced the risk of disease worsening or death compared with chemotherapy alone in the initial treatment of people with advanced squamous NSCLC. In the IMpower131 trial, patients received Tecentriq plus carboplatin and paclitaxel, Tecentriq plus carboplatin and Abraxane or carboplatin and Abraxane.

For related analysis, see ViewPoints: Merck & Co. tightens its Keytruda-shaped grip on the lung cancer market.

To read more Top Story articles, click here.