Sacituzumab Govitecan Plus Pembrolizumab Misses Primary Endpoints in Lung Cancer Study
Sacituzumab govitecan combined with pembrolizumab did not achieve statistically significant improvements in progression-free survival or overall survival for first-line metastatic non-small cell lung cancer patients with high PD-L1 expression.
The combination of sacituzumab govitecan (SG) and pembrolizumab failed to meet its primary endpoints in the Phase 3 EVOKE-03/KEYNOTE-D46 trial, which investigated the treatment of patients with PD-L1-high metastatic non-small cell lung cancer (NSCLC) in the first-line setting. Although the study showed numerically longer progression-free survival (PFS) and higher response rates, statistical significance was not achieved for the key endpoints.
The results thus demonstrated no statistically significant difference in PFS or overall survival (OS) compared to standard treatment. The trial was randomized and placebo-controlled, aiming to evaluate the efficacy and safety of SG and pembrolizumab in this patient group, often characterized by a poor prognosis.
Developers noted that while the study did not meet statistical significance on its primary endpoints, numerical trends were observed, suggesting potential benefit in certain patient subgroups. The safety profile of the study was as expected, with no new significant adverse events identified.
The findings from the EVOKE-03 study are significant as they do not support the use of SG and pembrolizumab in this specific patient population as a first-line treatment per current indications. Further research is needed to better understand the combination's potential role in lung cancer treatment and to identify patient subgroups that may benefit.