Gilead's Sacituzumab Govitecan Fails to Meet Primary OS Endpoint in Phase III EVOKE-01 Study for NSCLC

On January 22, Gilead Sciences announced that the Phase III EVOKE-01 study of sacituzumab govitecan (brand name: Trodelvy) versus docetaxel in previously treated patients with metastatic or advanced non-small cell lung cancer (NSCLC) did not meet the primary endpoint of overall survival (OS).

Sacituzumab Govitecan is a TROP2-targeted ADC developed by Gilead Sciences. It was first approved for marketing in the United States in April 2020, making it the world's first approved TROP2 ADC. To date, Sacituzumab Govitecan has been approved for three indications: 1) Adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies; 2) Adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor treatment; 3) Adult patients with unresectable locally advanced or metastatic HR+/HER2- (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have undergone endocrine therapy and at least two systemic therapies.

EVOKE-01 is a global, multicenter, open-label Phase III clinical trial (N=603) that evaluated the efficacy and safety of sacituzumab govitecan versus docetaxel in patients with metastatic or advanced NSCLC who progressed during or after treatment with platinum-based chemotherapy and checkpoint inhibitors.

The results showed that, compared with the docetaxel group, the OS of patients in the sacituzumab group was prolonged, although there was no significant difference between the two groups. However, in the subgroup of patients who had received PD-(L)1 inhibitor treatment but did not respond, the OS of patients in the sacituzumab group was significantly prolonged by more than 3 months; while this difference did not exist in the subgroup of patients who responded to PD-(L)1 inhibitor treatment. In view of this, Gilead Sciences decided to continue exploring the target population for sacituzumab.

In addition to the EVOKE-01 study, Gilead Sciences also conducted the EVOKE-03 study to evaluate the efficacy and safety of sacituzumab govitecan plus pembrolizumab versus pembrolizumab alone as a first-line treatment for patients with metastatic NSCLC whose PD-L1 TPS is ≥50%.

NSCLC is the most common type of lung cancer, accounting for approximately 85% of all lung cancer patients. Currently, there are several first-line treatment options available for NSCLC, including immune checkpoint inhibitors. However, only about 35%-55% of patients respond to combination therapies based on immunotherapy, and when the disease progresses in these patients, treatment options become even more limited.

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