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Antibody-drug conjugate fails to meet primary end point in lung cancer trial

January 23, 2024

Gilead Sciences announced Monday that the phase 3 EVOKE-01 study didn't meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).

EVOKE-01 evaluated Trodelvy (sacituzumab govitecan-hziy; SG) vs. docetaxel in 603 patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Trodelvy, which belongs to a class of treatments known as antibody-drug conjugates, was tested in patients with both squamous and non-squamous NSCLC. Antibody-drug conjugates combine antibodies, which bond with specific cancer cells, and toxins that are too potent to be given by themselves.

Although the late-stage study showed that patients with NSCLC, who were treated with Trodelvy, lived longer than those given chemotherapy, the difference wasn't statistically significant.

Trodelvy was generally well-tolerated, and no new safety signals were identified in this patient population.

Gilead is also conducting phase 2 and 3 trials of Trodelvy in combination with Keytruda as an initial treatment for NSCLC patients.

Sources:

Herper, M. (2024, January 22). STAT. Gilead's Trodelvy fails in lung cancer and raises new questions on antibody drug conjugate drugs. https://www.statnews.com/2024/01/22/gilead-trodelvy-fails-in-lung-cancer-and-raises-new-questions-on-antibody-drug-conjugates/

Beasley, D. (2024, January 22). Reuters. Gilead's Trodelvy fails to meet main goal in lung cancer trial. https://www.reuters.com/business/healthcare-pharmaceuticals/gilead-says-trodelvy-fails-meet-primary-goal-2nd-line-lung-cancer-trial-2024-01-22/

(2024, January 22). Gilead Sciences, Inc. Gilead Provides Update on Phase 3 EVOKE-01 Study. https://investors.gilead.com/news/news-details/2024/Gilead-Provides-Update-on-Phase-3-EVOKE-01-Study/default.aspx