Combination of Merck & Co.'s Keytruda, chemotherapy extends survival as first-line treatment for squamous NSCLC

Merck & Co. announced Wednesday that a Phase III study investigating Keytruda (pembrolizumab), in combination with carboplatin-paclitaxel or Celgene's Abraxane (nab-paclitaxel), as a first-line treatment for patients with metastatic squamous non-small-cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Results from the KEYNOTE-407 trial will be presented at the American Society of Clinical Oncology (ASCO) annual meeting.

Earlier this month, the company disclosed that it filed an application with the FDA seeking approval of Keytruda as a first-line treatment for patients with metastatic squamous NSCLC, based on an interim analysis of the KEYNOTE-407 study. At the time, Merck noted that the trial met a pre-specified secondary endpoint of overall response rate in an early cohort of patients, adding that an additional interim analysis would be conducted prior to ASCO.

On Wednesday, the drugmaker said that based on this further interim analysis conducted by the study's independent Data Monitoring Committee, treatment with Keytruda in combination with chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone. Merck indicated that the new data will be submitted to the FDA and also detailed at ASCO.

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.

The KEYNOTE-407 study randomised 560 untreated patients with metastatic squamous NSCLC to receive Keytruda in combination with carboplatin-paclitaxel or Abraxane, compared with carboplatin-paclitaxel or Abraxane alone. For related analysis, see ViewPoints: Merck & Co. tightens its Keytruda-shaped grip on the lung cancer market.

Keytruda gained accelerated approval last year in combination with Eli Lilly's Alimta (pemetrexed) and carboplatin in previously untreated patients with metastatic non-squamous NSCLC irrespective of PD-L1 expression. Earlier this year, the anti-PD-1 therapy was granted priority review by the FDA in combination with Alimta and platinum chemotherapy as a first-line treatment for patients with metastatic non-squamous NSCLC.

In March, Roche reported that in the Phase III IMpower131 study, 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 trial, 1021 people with stage IV squamous NSCLC who have not been previously treated with chemotherapy were randomised to receive Tecentriq plus carboplatin and paclitaxel, Tecentriq plus carboplatin and Abraxane or carboplatin and Abraxane. For related analysis, see ViewPoints: Roche looks to side-step rivals in lung cancer race but the jury is still out

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