Gilead Sciences now has more clinical data showing that its breast cancer drug Trodelvy helped patients live longer. The FDA now has that data too, as the drugmaker said Monday archive An application to expand the approval of a targeted drug to cover a broader population of breast cancer patients. But details about the data will have to wait. Gilead said the details will be presented at a future medical meeting.
Few details are available for the drug Trodelvy, follow Disappointing results announced during the American Society of Clinical Oncology (ASCO) annual meeting in JuneGilead said at the meeting that its drug improved progression-free survival by 34 percent — how long patients survive without their cancer getting worse — the primary goal of the phase 3 study.
Disappointing was the report on overall survival, a measure of how long patients live after treatment. Regarding this secondary clinical trial goal, Gilead said at ASCO that patients who received its drug lived an average of 5.5 months, just six weeks longer than those who received chemotherapy. Speaking at ASCO, Véronique Dieras, an oncologist at the Eugene Marquis Center in Rennes, France, acknowledged that the results were statistically significant in terms of overall survival, but said it was unclear whether extending median survival by another six weeks had any effect. clinical significance.
The Foster City, Calif.-based Gilead said Monday that the overall survival results were statistically and clinically meaningful. The company did not provide further explanation for the results, but did say the drug’s safety profile was consistent with earlier studies.
Trodelvy is an antibody-drug conjugate that delivers its cancer cell-killing drug payload to tumors by targeting TROP 2, a protein found on the surface of a variety of solid tumors, including most breast cancers. FDA approves Trodelvy for triple-negative breast cancer in 2020, a rare form of aggressive breast cancer. Gilead has been working to expand the drug’s approval to HR-positive/HER2-negative breast cancer, the most common type of breast cancer.Approval for this indication is important to achieve the blockbuster expectations for Trodelvy because Gilead buys Immunomedics for $21 billionthe biotech company that originally developed the treatment.
Gilead reported Trodelvy sales of $380 million in 2021. In the first half of the year, the company’s financial report showed that the drug generated $305 million in revenue, an increase of 89.4% compared to the same period in 2021.
Gilead has evaluated the drug in a phase 3 study of Trodelvy in patients with advanced HR2-positive/HER2-negative breast cancer whose disease has received extensive prior therapy, including hormone therapy, blocking CDK4/HER2-negative breast cancer that drives cancer growth 6 enzyme drugs, and two to four lines of chemotherapy.
Merdad Parsey, Gilead’s chief medical officer, said in a prepared statement that the latest Trodelvy results “are important to the breast cancer community and we are encouraged by the potential this may help other patients with limited options. We look forward to working with Global health authorities discuss these results as pretreated patients with HR-positive/HER2-negative metastatic disease currently have limited treatment options and poor quality of life.”
Gilead showed how much it believes in Trodelvy’s potential by acquiring the rights to the drug in China and other Asian markets. Everest Medicines acquired those rights in a 2019 deal with Immunomedics.Late Monday, Gilead announced it was $280 million paid to Mount Everest Access the rights to the drug in these Asian markets. Everest could receive up to $175 million in milestone payments related to the achievement of regulatory and commercial milestones. Trodelvy is approved for triple-negative breast cancer in China and Singapore. In other Asian markets, it’s under scrutiny.
Public Domain Image Courtesy of Stuart S. Martin National Cancer Institute
