Gilead Reports Positive Data From Trodelvy, Keytruda Combo Study

Gilead Sciences, Inc. GILD announced positive data on breast cancer drug Trodelvy (sacituzumab govitecan-hziy) from the late-stage ASCENT-04/KEYNOTE-D19 study.

Data from the phase III ASCENT-04/KEYNOTE-D19 showed Trodelvy plus Merck’s MRK blockbuster immuno-oncology drug Keytruda reduced the risk of disease progression or death by 35% compared with Keytruda and chemotherapy in first-line PD-L1+ metastatic triple-negative breast cancer (TNBC).

Gilead and Merck collaborated in 2021 to evaluate Trodelvy in combination with Keytruda in the phase III ASCENT-04/KEYNOTE-D19 study.

Shares of GILD have gained 20% year to date against the industry’s decline of 3.1%.

More on GILD’s & MRK’s ASCENT-04/KEYNOTE-D19 Study

The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized phase III study evaluating the efficacy and safety of Trodelvy in combination with Keytruda compared with the treatment of chemotherapy plus Keytruda in patients with previously untreated, inoperable locally advanced or metastatic TNBC whose tumors express PD-L1.

The study enrolled 443 patients across multiple study sites.

Patients were randomized equally in two arms - to receive either Trodelvy (10 mg/kg intravenously on Days one and eight of a 21-day cycle) plus Keytruda (200 mg intravenously on Day one of a 21-day cycle) or chemotherapy plus Keytruda.

The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.

Patients continued treatment until either blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Importantly, those who progress on chemotherapy can cross over to receive Trodelvy.

The primary endpoint of the study is progression-free survival (PFS) as determined by BICR using RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety.

In April 2025, GILD announced that the study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS.

A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, with a 35% reduction in the risk of disease progression or death in the intent-to-treat population compared to the standard of care Keytruda plus chemotherapy combination.

A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination. Additionally, a substantially longer DOR was observed with the combination ofTrodelvy plus Keytruda

While data showed encouraging trends in overall survival (OS), it was still immature at the time of PFS primary analysis. OS follow-up remains ongoing and will continue to be monitored as a key secondary endpoint.

The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of both drugs.

GILD Looks to Expand Trodelvy’s Label

TNBC is the most aggressive type of breast cancer.  In particular, first-line options remain limited for patients with PD-L1–positive metastatic TNBC.

Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.

Trodelvy is currently approved in more than 50 countries for second-line or later mTNBC patients and in several countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

Last month, Gilead posted positive top-line results from another late-stage study, ASCENT-03, on Trodelvy. Data from this phase III study showed highly statistically significant and clinically meaningful improvement in PFS in patients with first-line metastatic TNBC who are not candidates for checkpoint inhibitors.

This is the second positive phase III study in first-line mTNBC where Trodelvy has demonstrated a clinically meaningful benefit compared with standard of care chemotherapy.

Per GILD, positive data from the ASCENT-03 and ASCENT-04 study demonstrate Trodelvy’s potential as the backbone treatment for all patients across first-line mTNBC.

Gilead has additional ongoing phase III studies evaluating Trodelvy across HER2 breast cancer, including the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC). The drug is also being evaluated in additional late-stage studies across a range of tumor types, including lung and gynecologic cancers.

Gilead’s oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025.

Nonetheless, the potential launch of anito-cel in multiple myeloma and Trodelvy in first-line metastatic TNBC in 2026 will strengthen the company’s oncology business.

GILD’s Zacks Rank and Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate Novartis’ 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.6% so far this year.

Pfizer’s 2025 EPS estimate has risen from $2.97 to $3.06 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe.

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research