Posted by Michael Wonder on 21 Aug 2018
FDA approves expanded label for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
20 August 2018 - Approval based on results of KEYNOTE-189, where Keytruda in combination with pemetrexed and platinum chemotherapy reduced the risk of death by half compared to chemotherapy alone.
Merck today announced that the U.S. FDA has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta) and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumour aberrations, based on results of the KEYNOTE-189 trial.
In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless of PD-L1 tumour expression status, Keytruda in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001), reducing the risk of death by half compared to chemotherapy alone. The study also showed a significant improvement in progression-free survival compared to chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). Data from KEYNOTE-189 support that Keytruda is changing survival expectations for these patients.
