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A new drug is showing promising results in a trial working to understand its potential as a possible treatment option for women with endometrial cancer.
In a recent study, the drug sacituzumab tirumotecan (sac-TMT) was found to be associated with a reduced risk of endometrial cancer progression compared to standard chemotherapy, as well as a lower risk of death.
The drug could therefore be a promising new treatment for women with endometrial cancer - the fourth most common cancer for women in the U.S. and the most common cancer of the female reproductive system (it develops in the inner lining of the uterus).
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The cancer affects more than 68,000 women a year, according to the American Cancer Society, and more than 14,000 women die from endometrial cancer annually. When advanced or recurrent, it can be a difficult cancer to treat, as standard chemotherapy can stop working for some women. This means alternatives to chemotherapy, as well as additional treatment options, could potentially entail life-saving possibilities.
"These results matter because endometrial cancer is one of the few cancers where both the number of cases and the number of deaths are rising," study lead Dr. Domenica Lorusso, a professor of gynecology and oncology at Humanitas Research Hospital, Italy, told Newsweek.
"Chemotherapy combined with immunotherapy is the standard first treatment," she continued, but added that more women are seeing their cancer "return after both."
"These women have limited options and typically survive less than a year. In this study, median survival rose to 19 months with sac-TMT, compared with 12 months with chemotherapy," she said.
The results of the phase 3 clinical trial were published in the journal The Lancet on October 26.
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What The Study Found
The researchers included 776 women with advanced or recurrent endometrial cancer in the study, all of whom had received chemotherapy and immunotherapy previously.
Participants were enrolled across more than 200 cancer centers in almost 30 countries in Europe. They were split into two groups, one group receiving standard chemotherapy (390 women), and one group receiving the new drug (386 women).
In the study, the drug sac-TMT was found to be associated with a 41 percent reduced risk of endometrial cancer progression compared to chemotherapy, alongside a 32 percent reduced risk of death.
A greater number of women also responded well to the drug compared to those receiving chemotherapy, as 35 percent of women using the new drug experienced positive results such as tumor shrinkage, compared to 17 percent who experienced the same results with chemotherapy.
How Does The Drug Work?
Speaking to Newsweek about how the drug works, Lorusso said sac-TMT is an antibody-drug conjugate and that "a simple way to picture it is a guided missile."
"The antibody finds TROP2, a protein expressed by almost all endometrial cancer cells, and it carries a powerful chemotherapy-like payload straight to those cells," she said.
"A uniquely designed linker keeps the payload attached while the drug travels through the bloodstream," she continued. "Once the drug is taken inside the cancer cell, the payload is released," she said, meaning it "stops the cell from dividing and causes it to die."
"The payload can also spread to nearby tumor cells regardless of TROP2 expression, which is called a bystander effect," she said.
This differs to standard chemotherapy because it travels through the whole body, affecting both healthy and cancerous cells, while immunotherapy "doesn't kill cancer cells directly but helps the patient's own immune system recognize and attack them."
How Could It Be More Effective Than Standard Treatment?
Lorusso said that the she believes the reason the drug saw such promising results in comparison to standard treatment was that 98 percent of the patients in the study had tumors that expressed the TROP2 protein.
TROP2 is expressed in more than 90 percent of endometrial cancers, she said, making it "an effective way to direct treatment to the cancer."
She also said that the "bystander effect may help reach nearby cancer cells that have less TROP2," and that "patients also stayed on sac-TMT about twice as long as on chemotherapy, a median of 31 weeks versus 15."
"Staying on treatment longer gives a drug more time to work," she added, saying that as a result, responses were "twice as frequent (35 percent versus 17 percent) and lasted longer (median 11 versus 7 months)."
Were There Any Side Effects?
As with other cancer treatments available, there were side effects reported with the drug. Likely because of the fact it was typically used for the twice the length of time chemotherapy was given, more serious effects were found to be more common among those who used sac-TMT, Lorusso said.
The most common serious side effects with sac-TMT included anemia (24 percent), low white blood cell counts (20 percent) and mouth sores, also called stomatitis (10 percent).
Although, serious adverse events were similar between those taking the drug and those receiving chemotherapy—12 percent vs. 14 percent.
Lorusso said that most side effects were "manageable with supportive care and dose adjustments," for example for the mouth sores, they were "usually mild to moderate, started early, lasted a limited time and were managed with steroid mouthwash."
She also said that few patients stopped treatment because of side effects—three percent with sac-TMT compared with five percent with chemotherapy—and that "quality of life was maintained over time."
What Happens Next
Lorusso said that the U.S. Food and Drug Administration (FDA) has "accepted the application for priority review and set a target action date of June 15, 2027," and that the drug is "being studied in 18 ongoing global phase 3 trials, 10 of them in women's cancers."
Reference
Domenica Lorusso et al. (2026) Sacituzumab tirumotecan versus treatment of physician's choice in previously treated endometrial cancer (TroFuse-005/ENGOT-en23/GOG-3095): a randomised, open-label, phase 3 trial. The Lancet. https://doi.org/10.1016/S0140-6736(26)02099-4
Contact Newsweek editors on this story: Kara Dolman and Paul Donnelley.
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