Recently, Merck, known as MSD outside the US and Canada, announced that the US Food and Drug Administration (FDA) has approved pembrolizumab (KEYTRUDA®), the anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. Under the FDA’s accelerated approval regulations, this indication is approved based on tumour response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The approval was based on data from KEYNOTE-021, Cohort G1, in 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations and irrespective of PD-L1 expression. In this trial, pembrolizumab plus pem/carbo demonstrated an objective response rate (ORR) that was nearly double the ORR of pem/carbo alone (55% [95% CI: 42, 68] compared to 29% [95% CI: 18, 41], respectively; all responses were partial responses). Among patients who received pembrolizumab plus pem/carbo, 93% had a duration of response of six months or more (range 1.4+ to 13.0+ months) compared to 81% who received pem/carbo alone (range 1.4+ to 15.2+ months). In addition, findings demonstrated an improvement in PFS (HR 0.53 [95% CI, 0.31-0.91; p=0.0205]), with a median PFS of 13.0 months (95% CI, 8.3-not estimable) for patients treated with pembrolizumab plus pem/carbo compared to 8.9 months (95% CI, 4.4-10.3) with pem/carbo alone.
Link para a notícia: ESMO
