Merck (MSD) has reported that its Keytruda (pembrolizumab) along with chemotherapy (carboplatin and paclitaxel) met the primary endpoint of progression-free survival (PFS) in the Phase III NRG-GY018 trial.
The blinded, randomised, placebo-controlled Phase III NRG-GY018 trial was designed to assess the combination of Keytruda and standard of care chemotherapy (paclitaxel and carboplatin) against a placebo and chemotherapy alone to treat measurable stage III, IVA, IVB, or recurrent endometrial carcinoma, regardless of mismatch repair status patients.
In the trial, 819 participants were randomised to receive Keytruda along with chemotherapy every three weeks for approximately six cycles, and then Keytruda alone every six weeks for up to 14 cycles, or a placebo along with chemotherapy.
The findings showed that the combination of Keytruda and chemotherapy significantly improved PFS compared to chemotherapy alone in patients whose endometrial carcinoma was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR).
Keytruda’s safety profile was also found to be consistent with that observed in previous studies, with no new safety signals reported in the trial.
Merck Research Laboratories senior vice-president, chief medical officer, and global clinical development head Dr. Eliav Barr said: “In certain patients with advanced endometrial cancer who have progressed following prior systemic therapy and are not candidates for surgery or radiation, Keytruda has become an important treatment option, both as a monotherapy and in combination.
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“These latest results in the first-line setting are very encouraging and show the potential of Keytruda plus chemotherapy for patients with stage III to IV or recurrent disease regardless of mismatch repair status.”
The US National Cancer Institute (NCI), a part of the National Institutes of Health, sponsored the trial.