Monday, July 4, 2022

Gilead drug Trodelvi marginally delays breast cancer progression in late trial

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

A phase III study compared Trodelvi with chemotherapy in 543 patients with hormone-sensitive tumors who test negative for a receptor called HER2 and who had stopped responding to at least two previous lines of therapy.

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

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

Trodelvi, also known as sacituzumab govitecan, uses tumor-targeting antibodies to deliver an anti-cancer drug.

In the study’s first analysis, Trodelavi patients lived an average of 13.9 months, compared with 12.3 months for the chemotherapy group—a difference that was not statistically significant.

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“We’ll have to wait for it to mature,” Gilead chief executive Daniel O’Day told Reuters. “Final analysis for overall survival will most likely happen in 2024 … but we’ll see if we see it earlier.”

He said Gilead intends to seek US approval based on recent data, pending regular discussions with Food and Drug.

Patients with hormone-sensitive, HER2-negative metastatic breast cancer are treated with endocrine therapy with targeted drugs. As the disease becomes resistant, treatment is limited to chemotherapy with a shorter duration of benefit.

In March Gilead said the study met its main goal of reducing the risk of cancer progression or death, but did not disclose any details. Shortly after, the company reduced the value of its 2020 acquisition of the drug’s developer, Immunomedics, by $2.7 billion.

“If the data matures and a clear overall survival advantage emerges, we think there may be a viable path forward,” Evan Seegerman, analyst at BMO Capital Markets, said in a research note on Saturday.

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But he cautioned about potential competition from Enhartu — an AstraZeneca plc drug being studied for breast cancer patients with low levels of HER2.

The most common adverse side effects reported for Trodelvi patients were low white blood cell counts and diarrhea.

Trodelavi is already FDA-approved for treated metastatic triple-negative breast cancer and bladder cancer. It is being studied for use in several types of cancer.

O’Day said Gilead hopes to begin testing Trodelvy in the second half of this year as an initial treatment for hormone receptor-positive, HER2-negative breast cancer.

The drug’s US list price is $2,188 per vial, but Gilead did not provide details of the average dosage or duration of treatment.

According to Refinitiv, Wall Street analysts expect annual sales of the drug to exceed $2 billion in 2026, on average.

Nation World News Desk
Nation World News Desk
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