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

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

According to study data published on Saturday, Gilead Sciences Inc’s Trodelvy increased the time women with advanced stages of a common kind of breast cancer lived without their disease progressing by 1.5 months, or 34%.

Trodelvy was compared to chemotherapy in 543 individuals with hormone-sensitive malignancies who tested negative for the HER2 receptor and had failed to react to at least two previous courses of therapy.

The findings, which were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, demonstrate that the Trodelvy group has a progression-free survival rate of 5.5 months compared to 4 months for chemotherapy patients.

“Will some claim that this is a clinically significant difference?” ASCO’s chief medical officer, Dr. Julie Gralow, told Dailion. “The essential point here is that we have confirmation that this medicine works in theory… I’m confident it will be used.”

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Trodelvy, also known as sacituzumab govitecan, is an anti-cancer medication delivered by a tumor-targeting antibody.

Trodelvy patients lived a median of 13.9 months in the initial analysis, compared to 12.3 months in the chemotherapy group – a difference that was not statistically significant.

“We have to wait for that to grow,” Daniel O’Day, CEO of Gilead, told Dailion. “The overall survival final analysis will most likely be in 2024… but we’ll see if we can look at it sooner.”

Gilead plans to seek clearance in the United States based on the new evidence, pending customary conversations with the Food and Drug Administration, he added.

Endocrine therapy combined with targeted medications is used to treat patients with hormone-sensitive, HER2-negative metastatic breast cancer. As the disease gets more resistant, treatment options are limited to chemotherapies with shorter durations of effect.

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In March, Gilead announced that the research met its primary goal of lowering the risk of cancer progression or death, but provided no further data. Shortly after, the firm wrote down the value of its 2020 acquisition of Immunomedics, the drug’s developer, by $2.7 billion.

“We believe there could be a plausible way ahead if data develop and a clearer overall survival benefit emerges,” BMO Capital Markets analyst Evan Seigerman wrote in a research note on Saturday.

However, he raised concern about future competition from Enhertu, a medication developed by AstraZeneca Plc for breast cancer patients with low HER2 levels.

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Low white blood cell counts and diarrhea were the most common side effects reported by Trodelvy patients.

Trodelvy has already been approved by the FDA for metastatic triple-negative breast cancer and bladder cancer that has been previously treated. It’s being researched for usage in a variety of cancers.

Gilead aims to start a trial of Trodelvy as a first treatment for hormone receptor-positive, HER2-negative breast cancer in the second part of this year, according to O’Day.

The medicine has a list price of $2,188 per vial in the United States, but Gilead did not specify the average dose or treatment length.

According to Refinitiv, Wall Street analysts predict yearly sales of the medicine to exceed $2 billion by 2026.

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