Partners Gilead and MSD have presented full results from KEYNOTE-D46/EVOKE-03, the global, randomised, open-label Phase III study of Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) versus Keytruda alone in 620 patients with previously untreated, PD-L1 Tumour Proportion Score (TPS) at or above 50%, EGFR/ALK/ROS1 wild-type metastatic non-small cell lung cancer (NSCLC), at the 2026 World Conference on Lung Cancer after the study was terminated on 9 June.

At a median follow-up of 14.7 months, the combination posted a median PFS of 11.8 months versus 7.7 months for Keytruda monotherapy (HR 0.81, p=0.0252), falling short of statistical significance, while median OS was 21.5 months versus 22.8 months (HR 1.07, p=0.7155), confirming no survival benefit; confirmed ORR favoured the combination at 56.6% versus 43.7%, but median duration of response was nearly identical at 21.4 versus 21.3 months.

The safety gap is the headline risk: treatment-related adverse events (TRAEs) occurred in 93.2% of the combination arm versus 65.4% for Keytruda alone, with Grade 3 or higher TRAEs at 55.7% versus 16.5%, driven by anaemia, neutropenia, diarrhoea, and nausea.