February 4, 2023

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Gilead drug modestly delays breast cancer progression in late-stage trial

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Gilead Sciences Inc’s Trodelvy extended by 1.5 months, or 34%, the length of time women with advanced stages of a common type of breast cancer lived without their disease worsening, according to trial data presented on Saturday.

The Phase III study compared Trodelvy to chemotherapy in 543 patients with hormone-sensitive tumors that test negative for a receptor called HER2 and who had stopped responding to at least two earlier lines of therapy.

The data, presented in Chicago at the annual meeting of the American Society of Clinical Oncology (ASCO), show progression-free survival for the Trodelvy group of 5.5 months compared with 4 months for chemotherapy patients.

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“Some will argue is that really a clinically meaningful difference?” Dr. Julie Gralow, ASCO’s chief medical officer, told Reuters. “The real point here is we have proof of principle this drug works … I’m sure it will be used.”

Trodelvy, also known as sacituzumab govitecan, uses a tumor-targeting antibody to deliver an anti-cancer drug.

At the study’s first analysis, Trodelvy patients lived a median 13.9 months, compared to 12.3 months for the chemotherapy group – a difference that was not statistically significant.

“We have to wait for that to mature,” Gilead Chief Executive Daniel O’Day told Reuters. “The final analysis for overall survival will most likely be in 2024 … but we’ll see if we take a look at it earlier.”

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He said Gilead intends to seek U.S. approval based on the recent data, pending routine discussions with the Food and Drug Administration.

Patients with hormone-sensitive, HER2-negative metastatic breast cancer are…


2022-06-04 17:41:21

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