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A new treatment for endometrial cancer demonstrated strong potential in a Phase 3 clinical trial.
Drugmaker Merck announced Monday that the investigational drug sacituzumab tirumotecan (sac-TMT) met its “primary endpoints” of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer.
The TroFuse-005 trial is the first global Phase 3 trial to “demonstrate statistically significant improvement” in survival compared to chemotherapy in these patients, according to a Merck press release.
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This was also the first and only antibody-drug conjugate (ADC) to achieve such a result for endometrial cancer patients in this setting, the researchers stated.
An ADC is a targeted cancer therapy that delivers more of the drug to tumor cells while limiting damage to healthy cells.
The trial involved 776 patients with endometrial cancer whose disease worsened after receiving both platinum chemotherapy and immunotherapy.
The patients were randomly assigned sac-TMT, administered every two weeks, or a treatment of the physician’s choice, including doxorubin or paclitaxel chemotherapy. The patients were aware of which treatment they were receiving.
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Those receiving sac-TMT showed “clinically meaningful improvement” in their disease state compared to the treatment of physician’s choice, the researchers found.
The study also met response rate benchmarks and exhibited similar side effects to earlier studies of the same drug, Merck reported.
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The drugmaker did not disclose any statistics on exact survival benefit, response rate, side effect rates or other details, but the researchers aim to present this Phase 3 data at an upcoming medical meeting.
Dr. Domenica Lorusso, the study’s global lead investigator and professor of obstetrics and gynecology at Humanitas University and Humanitas San Pio X in Milan, wrote in a press release that these results show sac-TMT “may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide.”
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“Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting,” she added.
Dr. Brian Slomovitz, co-director of gynecologic oncology at Mount Sinai and an investigator on this trial, reflected on the study findings during an interview with Fox News Digital.
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“Unlike many other cancers that we are treating, the number of endometrial cancers and the number of deaths due to endometrial cancers are on the rise,” Slomovitz noted.
“In the United States, the number of deaths due to endometrial cancer has surpassed the number of deaths due to ovarian cancer, [making it] the deadliest of all gynecologic malignancies.”
Despite recent advancements introducing immunotherapy as the standard of care, “better treatment options” for patients with recurrent disease “remains an unmet need,” Slomovitz commented.
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“If the full data confirm this announcement, the key questions will be the magnitude of the survival benefit and the toxicity profile — those will define sac-TMT’s role,” he said.
“But an overall survival improvement in recurrent disease is a real, meaningful result for patients and their families, not just a statistical one.”
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