A Keytruda-chemotherapy combination has been accepted for a priority review by the FDA for certain patients with endometrial cancer.
The Food and Drug Administration (FDA) has granted a priority review for the treatment combination of Keytruda (pembrolizumab) and chemotherapy for patients with primary advanced or recurrent endometrial cancer, according to a news release from Merk, the manufacturing company of Keytruda.
More specifically, the combination of drugs includes Keytruda with two types of chemotherapy: carboplatin and paclitaxel. The FDA has a target action date for a potential approval on June 21, 2024, according to the news release.
This potential approval of the Keytruda-chemotherapy combination is important for patients with primary advanced or recurrent endometrial cancer because it may reduce the risk of disease progression (worsening or spreading), according to the phase 3 NRG-GY018 study published in the New England Journal of Medicine.
The trial included a total of 816 patients: 225 with mismatch repair deficient (dMMR) disease and 591 patients with mismatch repair proficient (pMMR) disease. The median follow-up for each cohort was 12 months for dMMR and 7.9 months for pMMR, according to the study.
Two treatment arms were included in the trial, in which the first arm included a placebo plus chemotherapy, whereas the second arm included the Keytruda-chemotherapy combination, ClinicalTrials.gov listed. Both MMR cohorts had a Keytruda combination arm and a placebo arm.
The researchers found that the novel drug combination reduced the risk of disease progression or death by 46% in the pMMR group, and 70% in patients in the dMMR group, compared with patients who only received chemotherapy.
The findings from the trial are also notable for patients because the researchers noted that the data suggested that incorporating immunotherapy, such as Keytruda, in first-line treatment for this patient population may lead to improved cancer-related outcomes, regardless of patients’ MMR statuses.
“Endometrial cancer is the most common type of gynecological cancer, and frontline treatment options are limited for patients with advanced stage or recurrent disease,” Dr. Ramez Eskander, principal investigator and gynecologic oncologist, University of California San Diego, Moores Cancer Center, said in Merck’s news release. “The use of Keytruda in this setting has the potential to address a significant unmet need for these patients.”
READ MORE: Next-Generation Sequencing Finds More Immunotherapy-Eligible Patients
In terms of side effects, the researchers determined that the most common side effects that occurred in 15% or more of patients in either cohort and arm included fatigue, peripheral sensory neuropathy (numbness and pain in hands and feet), anemia, nausea, constipation, diarrhea and thrombocytopenia (lower levels of platelets that could lead to bleeding problems).
More specifically, side effects of any cause occurred in 98.2% of patients with a dMMR status in the Keytruda group and 99.1% of patients with a dMMR status who received a placebo. Patients in the pMMR cohort had a frequency of side effects of any cause in 93.5% of patients who received Keytruda and 93.4% of patients who received a placebo, according to the study.
Side effects deemed severe (grade 3) to those leading to death (grade 5) occurred in 63.3% of patients with a dMMR status in the Keytruda arm and 47.2% of patients with a dMMR status in the placebo arm, the study noted. For patients in the pMMR cohort, 55.1% of patients in the Keytruda arm and 45.3% of patients in the placebo arm experienced this range of side effects, respectively.
READ MORE: Chemo Plus Tecentriq Shows Improvements in Endometrial Carcinoma
“If approved, Keytruda would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of mismatch repair status,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are committed to working closely with the FDA to bring Keytruda to these patients who are in need of additional treatment options, and we thank our collaborators for their partnership on this study.”
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