Gilead Sciences said that Trodelvy (sacituzumab govitecan-hziy; SG) has failed to meet the primary endpoint of overall survival (OS) in a Phase 3 lung cancer trial dubbed EVOKE-01.
The late-stage trial is evaluating the Trop-2-directed antibody-drug conjugate in 603 previously treated metastatic non-small cell lung cancer (NSCLC) in comparison to docetaxel.
The patients involved in the trial had their condition progressed on or after being subjected to platinum-based chemotherapy and checkpoint inhibitor therapy.
According to Gilead Sciences, numerical improvement in OS favouring Trodelvy was noted in the study. This included patients with squamous as well as non-squamous histology.
The drug’s safety profile was on par with previous studies and it was well tolerated generally. No new safety signals were observed in the patient population in the EVOKE-01 study, said Gilead Sciences.
A sub-group analysis revealed a median OS difference exceeding three months in favour of Trodelvy for patients who did not respond to their last prior anti-PD-L1 therapy, constituting over 60% of the trial population.
Although this analysis was pre-specified in the protocol, it was not alpha-controlled for formal statistical testing. Conversely, such a significant difference was not observed in the sub-group of patients who responded to their last prior anti-PD-L1 therapy.
Gilead Sciences said that it aims to explore potential pathways to gain a deeper understanding of the role that its Trop-2-directed antibody-drug conjugate may play in these patients, considering the substantial unmet medical need in this context.
Gilead Sciences chief medical officer Merdad Parsey said: “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development programme.
“Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent. We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”
Trodelvy has approval in nearly 50 countries for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults. The approval is for its use in patients who have undergone two or more prior systemic therapies, with at least one of them specifically targeting metastatic disease.
In the US, the drug also has an accelerated approval for the treatment of specific patients with second-line metastatic urothelial cancer.
