Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here.
Keytruda is an approved treatment for endometrial carcinoma. (Courtesy of Kena Betancur/Getty Images)
Merck’s Keytruda (pembrolizumab) has become a Food and Drug Administration (FDA)-approved treatment for yet another indication- unresectable or metastatic advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair (MSI-H or dMMR). This announcement adds another win to Merck’s trophy case, as the biologic has already impressed the biopharmaceutical industry with an extensive array of indications, including for three other gynecological cancers.
Keytruda is an anti-programmed death receptor therapy that utilizes monoclonal antibodies to block interactions between PD-1 and ligands. This interaction typically results suppresses T lymphocyte activation, allowing the proliferation of tumor cells. Patients must have attempted systemic therapy treatments without success and cannot be candidates for curative surgery or radiation.
About the Trial of Keytruda for Endometrial Carcinoma
The KEYNOTE-158 Phase II trial (NCT02628067) is a non-randomized, open-label trial that spans 27 study locations and involves various cohorts to evaluate Keytruda intervention of a multitude of advanced solid tumors.
The cohort of endometrial carcinoma patients is comprised of 90 patients aged between 35 and 56 and resulted in a 46% treatment response rate. The treatment regimen included an intravenous injection every three weeks for up to two years, so long as the patient did not display signs of disease progression or toxicity.
Patients underwent an average of 8.3 months of treatment before reaching either of these points. For 68% of the patients who responded to treatment, the positive physiological response continued for at least 12 months, with a smaller cohort experiencing 24 months of response.
The classification of endometrial carcinoma as MSI-H or dMMR accounts for 30% of cases. Previously, combination therapy with lenvatinib was approved, indicated for advanced endometrial carcinoma that is not categorized as MSI-H or dMMR. Over 65,000 women are diagnosed with endometrial carcinoma, and 12,500 fatalities are attributed to the disease annually. Endometrial carcinoma is the most prevalent of uterine cancers.
Along with endometrial carcinoma, Keytruda has been approved for treatment of non-small cell lung cancer, unresectable or metastatic melanoma, recurrent head and neck squamous cell carcinoma, Hodgkin lymphoma, B-cell lymphoma, urothelial carcinoma, non-muscle-invasive bladder cancer and microsatellite instability-high or mismatch repair deficient cancer.
Additionally, ongoing clinical trials are investigating Keytruda indicated for ovarian cancer, triple-negative breast cancer, metastatic castration-resistant prostate cancer, advanced-stage lung cancer, renal cell carcinoma and solid tumors with certain biomarkers. The biologic will likely continue to impress, as it is involved in over 1,700 clinical trials, evaluating how broad the treatment can reach.
Humanized monoclonal antibody treatments such as Keytruda have been heavily represented in the news since the onset of the COVID-19 pandemic, as the immunotherapeutic mechanism works to heighten the body’s immune response.
Other than using it to treat endometrial carcinoma, a Phase II collaboration with Imugene was also announced last week that will investigate the safety and efficacy of Keytruda in combination with Imugene’s HER-Vaxx., an immunotherapeutic B-cell activator. The collaboration, nextHERIZON, seeks to gather data on how patients with metastatic HER-2/neu over-expressing of gastroesophageal junction adenocarcinomas respond to the combination therapy.
Keytruda has been granted Orphan Drug Designation for research into rare cancers, in exchange for market exclusivity that aids in Merck’s financial successes.
