Keytruda (pembrolizumab) approved by FDA for first line treatment of PD-L1 non-small cell lung cancer- Merck Inc

The FDA has cleared Keytruda (pembrolizumab), from Merck Inc, for use in untreated patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations. The decision to make Keytruda the only anti-PD-1 therapy to be cleared in the first-line setting for these patients, came on the back of data from the pivotal Phase III KEYNOTE-024 study.

Results from the study showed that pembrolizumab significantly improved the primary endpoint of progression-free survival by approximately four months compared to chemotherapy (10.3 months versus 6.0 months). The secondary endpoint of overall survival was also significantly prolonged, and 80% of patients on pembrolizumab were alive at six months compared to 72% on chemotherapy. Pembrolizumab was associated with a higher overall response rate compared to chemotherapy (45% versus 28%), a longer duration of response, and lower incidences of all and serious (3/4) adverse events.