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Gilead Sciences has reported positive topline data from the randomised Phase III ASCENT-04/KEYNOTE-D19 trial of Trodelvy (sacituzumab govitecan-hziy) and MSD’s Keytruda (pembrolizumab) combo in individuals with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC).
Tumours in these individuals express programmed death-ligand 1 (PD-L1).
In the trial, the primary endpoint was met, demonstrating a progression-free survival (PFS) improvement against standard treatment of Keytruda plus chemotherapy.
The global, open-label trial is assessing the combo’s safety and efficacy with 443 subjects enrolled in several trial sites.
They were randomised to receive either the combo or chemotherapy and Keytruda, with the option for subjects on chemotherapy to switch to Trodelvy upon the progression of the disease.
The safety profile of the combination was found to be consistent with the known profiles of the individual agents, without any safety concerns observed.
While overall survival (OS), the secondary endpoint, is not yet mature, an early trend towards its improvement was observed with the combination therapy.
The company will be monitoring the OS results with further subject follow-up and analyses planned.
The ASCENT-04 findings underscore the potential of Trodelvy plus Keytruda as a new treatment option for subjects with previously untreated PD-L1+ mTNBC.
According to Gilead, Trodelvy is the sole approved Trop-2-directed antibody-drug conjugate (ADC) that has shown survival benefits in two types of metastatic breast cancers.
Gilead Sciences chief medical officer Dietmar Berger said: “These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer.”
The company has three Phase III trials evaluating Trodelvy across various breast cancer types, including ASCENT-03 for first line mTNBC subjects who are ineligible for PD-L1-based therapy, ASCENT-05 for early-stage TNBC, and the ASCENT-07 study for hormone receptor + human epidermal growth factor receptor 2 - (HR+/HER2-) mBC patients post-endocrine therapy.
Last November, Gilead announced the outcomes from the Phase III PURPOSE 2 trial assessing lenacapavir for human immunodeficiency virus (HIV) prevention.
"Gilead reports topline data from Phase III trial of Trodelvy combo therapy" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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