Gilead Sciences, Inc. GILD on Monday launched topline outcomes from the Part 3 ASCENT-04/KEYNOTE-D19 research of Trodelvy (sacituzumab govitecan-hziy) plus Merck & Co Inc’s MRK Keytruda (pembrolizumab).
The trial demonstrated that Trodelvy plus Keytruda considerably improved progression-free survival (PFS) in comparison with Keytruda and chemotherapy in sufferers with inoperable (unresectable) regionally superior or metastatic triple-negative breast most cancers (mTNBC) whose tumors categorical PD-L1 (CPS ≥ 10).
The research met its major endpoint, displaying a statistically vital and clinically significant enchancment in PFS.
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The protection profile of Trodelvy plus Keytruda within the ASCENT-04 research was in line with every agent’s recognized security profile. No new security indicators have been recognized with the mixture.
“These findings are the primary to indicate the transformative potential of an antibody-drug conjugate mixed with an immuno-oncology agent in early therapy traces of metastatic breast most cancers,” mentioned Dietmar Berger Chief Medical Officer, Gilead Sciences.
Total survival (OS) is a key secondary endpoint and was not mature on the time of the PFS major evaluation. Nonetheless, within the ASCENT-04 research, there was an early pattern in enchancment for OS with Trodelvy plus Keytruda.
Gilead will proceed to watch OS outcomes, with ongoing affected person follow-up and additional analyses deliberate.
Detailed outcomes from the research can be introduced at a future medical assembly and mentioned with regulatory authorities.
Using Trodelvy plus Keytruda in sufferers with beforehand untreated PD-L1+ metastatic TNBC is investigational, and the security and efficacy of this use haven’t been established.
Trodelvy is the one accepted Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated significant survival benefits in two sorts of metastatic breast cancers: 2L+ mTNBC and pre-treated HR+/HER2- mBC.
It’s a Class 1 most popular therapy for each indications per the Nationwide Complete Most cancers Community (NCCN) Medical Follow Pointers in Oncology (NCCN Pointers) and the one ADC with an ESMO Magnitude of Medical Profit Scale (MCBS) score of 5 for mTNBC.
Trodelvy additionally has an MCBS score of 4 for ladies with HR+/HER2- mBC.
At the moment, Gilead has three ongoing Part 3 research investigating Trodelvy throughout HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) mBC, together with the upcoming ASCENT-03 pivotal trial in 1L mTNBC sufferers who are usually not candidates for PD-L1 based mostly remedy, the ASCENT-05 pivotal trial in sufferers with early-stage TNBC, and the ASCENT-07 pivotal trial in sufferers with HR+/HER2- mBC who’ve obtained endocrine remedy.
Trodelvy can be being investigated in further Part 3 research in different illness settings, together with lung and gynecological cancers.
Value Motion: GILD inventory is down 0.46% at $104.06 on the final verify Monday.
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