A new anti-cancer medication, sacituzumab tirumotecan (sac-TMT), has demonstrated significant progress in combating endometrial cancer, a disease responsible for over 97,000 deaths globally each year. The findings stem from a phase 3 international study led by researchers at NYU Langone Health and its Perlmutter Cancer Center.
Endometrial cancer, the most common malignancy of the female reproductive system, is becoming increasingly deadly and often presents limited treatment options, particularly in advanced stages. The study evaluated sac-TMT against standard chemotherapy drugs for patients with advanced or recurrent endometrial cancer who had previously undergone treatment with a PD-1 inhibitor. The results, published in a press release from NYU Langone, indicate that sac-TMT offers a substantial improvement over conventional chemotherapy.
Patients treated with sac-TMT experienced a 41% lower risk of their cancer progressing or spreading compared to those receiving chemotherapy. Furthermore, the drug was associated with a 32% lower overall risk of death. Tumors showed shrinkage in 35% of patients treated with sac-TMT, more than double the response rate observed with standard chemotherapy.
"These positive results from the first phase 3 trial using sacituzumab tirumotecan after immunotherapy establishes this drug as a new standard treatment in recurrent endometrial cancer," stated Bhavana Pothuri, the study's principal investigator. Sac-TMT functions as a targeted therapy by binding to the trophoblast cell-surface antigen 2 (Trop-2) protein, which is prevalent on the surface of endometrial cancer cells. As an antibody-drug conjugate, it delivers the medication directly to tumor cells, aiming to minimize damage to healthy tissues.
While the treatment did present side effects, most commonly low blood counts, mouth inflammation, and dry or itchy eyes, researchers deemed them manageable. The study's success also suggests potential applications for sac-TMT in other cancers characterized by high Trop-2 expression, including lung, breast, ovarian, and intestinal tumors.
These findings align with results from a separate phase 3 clinical trial conducted by Merck, the TroFuse-005 trial. That study also demonstrated statistically significant improvements with sacituzumab tirumotecan compared to chemotherapy in patients with advanced or recurrent endometrial cancer. Over 770 patients participated in the Merck trial, receiving either sac-TMT or a physician's choice of chemotherapy. Although Merck did not release specific statistical data on survival benefits or exact response rates, they confirmed the drug met response rate benchmarks and exhibited side effect profiles consistent with earlier studies.
In light of these positive outcomes, Pothuri recommends that clinical guidelines for endometrial cancer management be updated to include sacituzumab tirumotecan. The advancement offers significant hope for women facing this challenging disease, particularly those diagnosed at later stages or whose cancer has recurred after initial treatment. "Our study offers much-needed hope to women worldwide living with endometrial cancer, which is increasing in both incidence and mortality," added Michelle Lightfoot, an assistant professor at NYU Grossman School of Medicine and a co-investigator on the study.