Gilead Cancer Drug Combined With Merck's Drug Effective In Difficult To Treat Type Of Breast Cancer

Gilead Sciences, Inc. GILD on Monday released topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study of Trodelvy (sacituzumab govitecan-hziy) plus Merck & Co Inc’s MRK Keytruda (pembrolizumab).

The trial demonstrated that Trodelvy plus Keytruda significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10).

The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS.

Also Read: Trump Administration Weighs Deep Cuts To Domestic HIV Prevention Programs, Gilead Stock Slides

The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with each agent’s known safety profile. No new safety signals were identified with the combination.

“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,” said Dietmar Berger Chief Medical Officer, Gilead Sciences.

Overall survival (OS) is a key secondary endpoint and was not mature at the time of the PFS primary analysis. However, in the ASCENT-04 study, there was an early trend in improvement for OS with Trodelvy plus Keytruda.

Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analyses planned.

Detailed results from the study will be presented at a future medical meeting and discussed with regulatory authorities.

The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ metastatic TNBC is investigational, and the safety and efficacy of this use have not been established.

Trodelvy is the only approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two types of metastatic breast cancers: 2L+ mTNBC and pre-treated HR+/HER2- mBC.

It is a Category 1 preferred treatment for both indications per the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the only ADC with an ESMO Magnitude of Clinical Benefit Scale (MCBS) rating of 5 for mTNBC.

Trodelvy also has an MCBS rating of 4 for women with HR+/HER2- mBC.

Currently, Gilead has three ongoing Phase 3 studies investigating Trodelvy across HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) mBC, including the upcoming ASCENT-03 pivotal trial in 1L mTNBC patients who are not candidates for PD-L1 based therapy, the ASCENT-05 pivotal trial in patients with early-stage TNBC, and the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy.

Trodelvy is also being investigated in additional Phase 3 studies in other disease settings, including lung and gynecological cancers.

Price Action: GILD stock is down 0.46% at $104.06 at the last check Monday.

Read Next:

• Upexi Raises $100 Million To Expand Crypto Ventures, Stock Soars

Photo by Michael Moloney via Shutterstock