FDA Grants Priority Review to Merck Cancer Drug
United States health regulators accepted an experimental drug from Merck for priority review following late-stage clinical trial data demonstrating prolonged survival in women with advanced endometrial cancer, Reuters reported. The therapy, called sacituzumab tirumotecán or sac-TMT, targets cells expressing the TROP2 protein, which is highly prevalent in uterine tumors.
Clinical Trial Results and Patient Outcomes
The TroFuse-005/ENGOT-en23/GOG-3095 trial evaluated 776 patients whose cancer had returned or progressed after previous treatments, according to Infosalus. Patients were randomized to receive either sac-TMT or a physician’s choice of standard chemotherapy, such as doxorubicin or paclitaxel. Results showed that sac-TMT reduced the risk of death by 32% compared to standard chemotherapy. Patients receiving the experimental drug achieved a median overall survival of 19 months, versus 12.1 months for the chemotherapy group.
$MRK $MRNA $XBIMerck’s Endometrial Cancer Drug Cuts Risk Of Death By 32% – FDA Decision Due By June 2027In the 776-patient Phase 3 trial, Sac-TMT-treated patients had a median overall survival of 19 months compared to 12.1 months for chemotherapyThe treatment reduced the risk… pic.twitter.com/lmcfnVU2qI
Furthermore, the treatment decreased the risk of cancer progression or death by 41%, with patients remaining progression-free for a median of 7.2 months compared to 3.9 months with standard chemotherapy. Approximately 35% of patients treated with sac-TMT experienced tumor shrinkage, compared to 17% in the chemotherapy arm. The study data were presented at a medical congress hosted by the European Society for Medical Oncology (ESMO).
Safety Profile and Side Effects
Severe treatment-related adverse events occurred more frequently with sac-TMT, affecting roughly 54% of patients compared to 41% of those receiving standard chemotherapy. Approximately 3% of patients discontinued the drug due to side effects. Researchers noted that complications such as stomatitis and ocular toxicity require early identification and management, including oral rinses and eye lubricants, to maintain patient quality of life.
Uterine Cancer Statistics and Drug Development
The American Cancer Society projects approximately 68,000 new diagnoses of endometrial cancer in the United States, alongside more than 14,000 deaths. Merck is developing the antibody-drug conjugate in collaboration with Chinese biotechnology firm Kelun-Biotech, which originally discovered the therapy.
Regulatory Timeline for the Merck Therapy
Merck announced that the United States Food and Drug Administration expects to reach a final regulatory decision on the priority review application by June 2027.
Frequently Asked Questions About Sac-TMT
What specific protein does sacituzumab tirumotecán target?
Sac-TMT targets TROP2, also known as the trophoblast cell surface antigen 2, which is found in abundance on the surface of endometrial cancer cells to deliver a tumor-destroying payload.
How many patients participated in the pivotal phase 3 trial?
The international study included 776 patients whose endometrial cancer had reappeared or progressed after prior therapies involving platinum-based chemotherapy and immunotherapy.
What companies are collaborating on the development of sac-TMT?
Merck is developing the experimental antibody-drug conjugate jointly with Kelun-Biotech, the Chinese biotechnology company that discovered the compound.
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