A breakthrough treatment has made significant progress, showing promising results in decreasing recurrence and death from a devastating disease.
Led by researchers from NYU Langone Health and its Perlmutter Cancer Center, the landmark international study looked at the effects of anti-cancer medicine sacituzumab tirumotecan (sac-TMT) compared to standard chemotherapy drugs.
The results of the phase 3 trial could offer hope for a disease that kills more than 97,000 people around the world each year.
The most common cancer in the female reproductive system, endometrial cancers are becoming deadlier, yet have few effective treatment options, especially if diagnosed at a later stage.
The study compared sac-TMT to standard chemotherapy drugs for advanced or recurrent endometrial cancer in women who had already been treated with an established PD-1 inhibitor drug that makes cancer cells more visible to immune system attack.
The ones treated with the investigational drug had a 41% lower risk of their cancer progressing and spreading to other parts of the body than chemo alone, and a 32% lower overall risk of death.
Meanwhile, 35% of women treated with sac-TMT showed positive responses, including tumor shrinkage, more than twice that of those who underwent 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,” study principal investigator Bhavana Pothuri said in a press release.
Sac-TMT is designed to attach to the trophoblast cell-surface antigen 2 (Trop-2) protein that sits on the surface of endometrial cancer cells.
As an antibody-drug conjugate, the new drug is a targeted cancer therapy that delivers more drug to tumor cells while limiting damage to healthy cells.
The treatment wasn’t without side effects, though, with the most frequent ones including low blood counts, inflammation in the mouth and dry or itchy eyes.
Still, the researchers reported all of the adverse effects were manageable.
The positive results of the study also show promise for use of the sac-TMT drug in other cancers with excessive amounts of Trop-2, such as lung, breast, ovarian and intestinal tumors.
The study from NYU Langone showed similar results to another phase 3 clinical trial conducted by drugmaker Merck back in May.
The TroFuse-005 trial was the first global trial to “demonstrate statistically significant improvement” from sacituzumab tirumotecan compared to chemotherapy, according to a Merck press release.
More than 770 patients with endometrial cancer received either sac-TMT every two weeks or a treatment of the physician’s choice, including doxorubicin or paclitaxel chemotherapy.
Those who were administered sac-TMT showed “clinically meaningful improvement” in their disease state compared to the treatment of the physician’s choice.
While Merck didn’t disclose any statistics on exact survival benefit, response rate, side effect rates or other details, they reported the drug met response rate benchmarks and exhibited similar side effects to earlier studies.
As a result of the Merck clinical trial and the NYU Langone study, Pothuri recommends that “clinical guidelines for endometrial cancer will need to be reassessed to incorporate sacituzumab tirumotecan.”
The new treatment can offer hope for women dealing with the devastating disease, especially those in later stages or who have already undergone chemotherapy.
“Our study offers much-needed hope to women worldwide living with endometrial cancer, which is increasing in both incidence and mortality,” study co-investigator Michelle Lightfoot, an assistant professor at NYU Grossman School of Medicine, said in a press release.
