After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences' antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication.
In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).
The study specifically assessed the TROP2-targeted ADC in patients who aren’t candidates for PD-1 or PD-L1 inhibitors, either because their tumors don’t express the PD-L1 protein or because the patients are ineligible for immunotherapy treatment, Gilead said Friday.
The “highly statistically significant and clinically meaningful" improvement on the progression-free survival metric allowed the study to meet its primary endpoint, Gilead said. The company will discuss the Ascent-03 results with regulators and plans to present detailed results from the trial at an upcoming medical meeting.
Trodelvy’s safety was on par with what’s been seen in previous trials, and no new safety signals cropped up in Ascent-03, Gilead added. Overall survival (OS) data, one of the trial’s key secondary endpoints, aren’t yet mature, Gilead explained in its press release. That said, no OS detriment has been observed so far.
“The ASCENT-03 outcome represents the first clinically meaningful advance for this patient population in over 20 years versus chemotherapy,” Dietmar Berger, M.D., Ph.D., Gilead’s recently installed chief medical officer, said in a statement. “By addressing this aggressive and difficult to treat disease earlier, we can potentially improve treatment options for the high unmet need that patients with metastatic triple-negative breast cancer face.”
Trodelvy’s solo win against chemotherapy comes a month after the drug successfully teamed up with Merck & Co.’s Keytruda in the Ascent-04 trial. In the study, the ADC-immunotherapy cocktail proved better than Keytruda and chemotherapy on progression-free survival in previously untreated TNBC patients with PD-L1-expressing tumors.
Gilead plans to share detailed results from Ascent-04 at the American Society of Clinical Oncology meeting beginning next Friday.
Now armed with data in PD-L1-positive and PD-L1-negative breast cancer patients, Gilead figures Trodelvy “has the potential to be the backbone treatment for all patients across first-line mTNBC," the company said in its release.
The trial win comes as Gilead's drug faces increasing pressure from a pair of new TROP2 ADC rivals.
AstraZeneca and Daiichi Sankyo’s Datroway won an FDA nod in January for HR-positive, HER2-negative breast cancer in patients who have tried prior endocrine-based therapy and chemotherapy, teeing up a showdown with Trodelvy in the U.S. Meanwhile, Trodelvy is also duking it out with Kelun-Biotech’s Merck-partnered sacituzumab tirumotecan (sac-TMT) in China, where regulators approved the partners’ ADC in November.
Trodelvy has also made a number of recent fumbles in the clinic, removing some of the shine from the asset that once formed a key part of Gilead’s overall oncology strategy.
Still, the California drugmaker continues to trial Trodelvy in a range of breast cancer populations. The Ascent-07 study, for instance, is looking at the drug in HER2-negative breast cancer patients who’ve received an endocrine therapy, while Ascent-05 is assessing Trodelvy in patients with early-stage TNBC.
For all of 2024, Trodelvy sales grew 24% compared with the prior year to $1.3 billion. In 2025’s first quarter, the med's sales slipped 5% to $293 million, which Gilead largely attributed to inventory fluctuations.
Consensus estimates currently place Trodelvy’s peak sales potential at around $2.9 billion by 2030, although analysts at Citi last month predicted the number could reach as high as $3.2 billion.
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