Update on Trodelvy's Phase 3 EVOKE-01 NSCLC Trial Results

Gilead Sciences, a biopharmaceutical company, has reported that the Phase 3 EVOKE-01 clinical trial of its drug Trodelvy® (sacituzumab govitecan-hziy; SG) did not achieve its primary goal of improving overall survival in patients with metastatic non-small cell lung cancer (NSCLC) who had undergone prior treatment with platinum-based chemotherapy and checkpoint inhibitors. Despite this, the drug showed a numerical improvement in overall survival, particularly in patients with both squamous and non-squamous histology. The drug's safety profile remained consistent with earlier trials, indicating good tolerability and no new safety concerns.
A significant finding was a three-month median overall survival benefit for patients unresponsive to their last anti-PD-(L)1 treatment, which represents over 60% of the trial's participants. This subgroup analysis was planned but not formally statistically tested. Gilead plans to engage with regulatory authorities to discuss the trial's outcomes and will present the data at an upcoming medical conference. The company is optimistic about Trodelvy's potential in treating NSCLC and continues to explore its role in this patient group due to the significant unmet medical need.
Gilead's extensive clinical development program for metastatic NSCLC includes several Phase 3 and Phase 2 trials. Encouraged by the preliminary results of the Phase 2 EVOKE-02 study, which combined Trodelvy with pembrolizumab, Gilead remains confident in its ongoing Phase 3 EVOKE-03 study for first-line metastatic NSCLC with high PD-L1 expression. The company also has a broad program for lung cancer treatment with domvanalimab, an experimental anti-TIGIT antibody.
Although there have been advancements in immunotherapy for first-line metastatic NSCLC, the majority of patients will see their cancer progress, with only a portion responding to immunotherapy combinations. For those who do not respond to initial immunotherapy, there are limited treatment options, making the development of new treatments a pressing challenge.
Trodelvy is an antibody-drug conjugate (ADC) that targets Trop-2, a protein overexpressed in various cancers. It has been approved in nearly 50 countries for treating triple-negative breast cancer and certain cases of metastatic urothelial cancer. However, it is not yet approved for metastatic NSCLC, and its safety and efficacy for this condition are still under investigation.
The EVOKE-01 study, a global, open-label, randomized trial, involved 603 participants and assessed Trodelvy against docetaxel. The primary endpoint was overall survival, with secondary endpoints including progression-free survival, objective response rate, and safety measures. Additional details about the study can be found on clinicaltrials.gov.
Trodelvy's U.S. indications include the treatment of certain patients with triple-negative breast cancer and urothelial cancer. It carries a boxed warning for severe or life-threatening neutropenia and severe diarrhea. The drug has not been approved for use in patients with reduced UGT1A1 activity, and its embryo-fetal toxicity necessitates contraception advice for patients of reproductive potential.
Gilead Sciences, headquartered in Foster City, California, is dedicated to creating innovative medicines to combat life-threatening diseases such as HIV, viral hepatitis, COVID-19, and cancer. The company operates globally, with a commitment to improving public health.