Gilead sinks after Trodelvy misses survival goal in lung cancer trial
22 Jan 2024
Phase 3Clinical ResultADCPhase 2
Shares in Gilead Sciences were down 11% on Monday after the company reported that its Trop-2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) missed the primary endpoint in a Phase III trial of patients with metastatic non-small-cell lung cancer (NSCLC).
The EVOKE-01 study compared Trodelvy to docetaxel in 603 patients with advanced or metastatic NSCLC that progressed after platinum-based chemotherapy and checkpoint inhibitor treatment. While Trodelvy showed a numerical improvement on the primary endpoint of overall survival (OS) for both squamous and non-squamous NSCLC, the difference was not statistically significant.
However, a subgroup analysis showed Trodelvy improved median OS by over 3 months compared to chemotherapy in patients who did not respond to their last PD-(L)1 inhibitorPD-(L)1 inhibitor therapy. This subgroup accounted for over 60% of trial participants, and Gildead plans to do further analyses to better understand the role Trodelvy may have played.
Meanwhile, the company says it didn't see this "magnitude of difference" in patients who responded to their last anti-PD-(L)1 therapy. Although pre-specified in the study protocol, the analysis was not subjected to formal statistical testing for alpha control.
"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," said chief medical officer Merdad Parsey.
Gilead is also conducting Phase II and III trials of Trodelvy in combination with Merck & Co.'s Keytruda (pembrolizumab) as an initial treatment for NSCLC patients, although Parsey indicated that Phrase III testing in the front-line setting is enrolling, but will not be available for "a couple of years at least."
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