Merck & Co.'s Keytruda garners FDA approval in combination with chemotherapy as first-line treatment for NSCLC regardless of PD-L1 status

Merck & Co. announced that the FDA approved Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or Celgene's Abraxane (nab-paclitaxel), for the first-line treatment of patients with metastatic squamous non-small-cell lung cancer (NSCLC). The company noted that the clearance is the first time an anti-PD-1 regimen has been authorised for the first-line treatment of squamous NSCLC regardless of tumour PD-L1 expression status.

The approval is based on results from the Phase III KEYNOTE-407 trial, with findings presented at the American Society of Clinical Oncology (ASCO) annual meeting in June showing that Keytruda in combination with chemotherapy significantly improved overall survival, reducing the risk of death by 36 percent compared to chemotherapy alone. Merck's submission, which was granted priority review by the FDA, also included results demonstrating that the combination of Keytruda and chemotherapy significantly improved progression-free survival and objective response rate versus chemotherapy alone.

Roger Perlmutter, president of Merck Research Laboratories, said that the "approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat." The company noted that following the latest clearance, "all appropriate patients with metastatic squamous NSCLC and all appropriate patients with metastatic non-squamous NSCLC and no EGFR or ALK genomic tumour aberrations are now eligible for a Keytruda-based regimen as their first-line treatment option."

Last week, Merck reported that third-quarter sales of Keytruda jumped 80 percent year-over-year to $1.9 billion. For related analysis, see ESMO 2018 Interview: Little to concern Merck & Co. and its kingmaker Keytruda; and much to cheer where Lynparza is concerned.

To read more Top Story articles, click here.