The FDA has approved Keytruda with chemotherapy in certain patients with advanced or recurrent endometrial cancer.
The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) plus carboplatin and paclitaxel, followed by Keytruda-only for adults with primary advanced or recurrent endometrial carcinoma, according to a press release from the agency.
The approval was based off findings from the KEYNOTE-868/NRG-GY018 trial, which included 810 patients with advanced or recurrent endometrial carcinoma. A total of 222 patients’ disease was mismatch repair deficient (dMMR; meaning that there is a mutation that interferes with the way cells copy their DNA, leading to cancer) and 588 patients were mismatch repair proficient (pMMR).
The patients in the study were randomly assigned to one of two treatment groups. The first group received Keytruda every three weeks and paclitaxel and carboplatin for six cycles, followed by Keytruda every six weeks for up to 14 cycles. The other group received a placebo (inactive drug) every three weeks, and paclitaxel plus carboplatin for six cycles, followed by six weeks of placebo for up to 14 cycles.
The main goal of the trial was to determine if there was a difference in progression-free survival (PFS), which is the time patients live before their disease worsens.
In the dMMR cohort, the median PFS was not reached for those who received Keytruda, meaning that not enough patients experienced disease worsening at the time of data collection for the researchers to determine an average. Meanwhile, it was 6.5 months for patients with dMMR disease who received a placebo plus chemotherapy.
In the pMMR group, the median PFS was 11.1 months in the Keytruda group compared with 8.5 months in the placebo group.
Keytruda is a type of immunotherapy drug called a checkpoint inhibitor. It works by binding to the PD-1 immune pathway, thereby helping the immune system to find and attack the cancer cells.
The Keytruda-related side effects observed in KEYNOTE-868/NRG-GY018 aligned with side effects that were commonly observed with Keytruda in previous studies, with the exception of a higher incidence of rash, according to the press release.
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