US-based biopharmaceutical company Gilead Sciences has reported that its Phase III EVOKE-01 trial of Trodelvy (sacituzumab govitecan-hziy; SG) for metastatic non-small cell lung cancer (NSCLC) failed to meet the primary endpoint.
The multicentre, open-label trial assessed the therapy against docetaxel in advanced NSCLC patients who had received prior treatment and whose disease had progressed after receiving platinum-based chemotherapy and checkpoint inhibitor treatment.
It enrolled 603 subjects and analysed overall survival (OS) as the primary endpoint.
Progression-free survival, duration of response, objective response rate and disease control rate were assessed as key secondary goals.
Despite not meeting the primary goal, an improvement in OS trending towards Trodelvy was reported in the trial, including in subjects with squamous and non-squamous histology.
The drug was found to be well-tolerated with no new safety issues detected, while its safety profile matched that reported in previous trials.
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In a sub-group of subjects who were non-responsive to previous anti-PD-(L)1 therapy, which constituted more than 60% of the trial population, a median OS difference of more than three months favouring Trodelvy was reported.
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 secured approvals in almost 50 countries for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously undergone multiple systemic treatments.