Keytruda (pembrolizumab) plus chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone for advanced or recurrent endometrial carcinomas, Merck has announced.
The Phase III trial (NCT03914612) involved 591 patients with stage III-IV or recurrent endometrial carcinoma – GlobalData predicts that by 2030 there will be 65,000 diagnoses in the US. It is the sixth most common cancer in women.
“Results from this trial show that Keytruda plus chemotherapy, if approved, may represent an important new first-line immunotherapy option for patients with stage III-IV disease, and could extend the use of Keyruda to more patients earlier in their treatment journey,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories.
Keytruda was used in cominbation with a standard of care chemotherapy, then continued as a single agent every six weeks for up to 14 cycles for first-line treatment.
The Keytruda regimen demonstrated a statistically significant and clinical improvement in PFS for patients, regardless of mismatch repair status. After a median follow-up of 7.9 months, Keytruda regimen significantly reduced the risk of disease progression or death by 46%. No new safety signals were identified, and adverse events occurred in 55.1% of patients taking the regimen.
“The significant improvement in progression-free survival regardless of mismatch repair status observed in this study demonstrates the potential of this pembrolizumab regimen to benefit these patients,” said Dr. Ramez Eskander, principal investigator and gynecologic oncologist at the University of California San Diego, Moores Cancer Center.
GlobalData predicts 2030 pharmaceutical market sales for endometrial cancer treatment to be $5.3bn globally.