EU approves Keytruda cervical cancer in adults whose tumors express PD-L1
Merck Inc announced that the European Commission has approved Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] at least 1).
This approval is based on results from the Phase III KEYNOTE-826 trial, in which Keytruda plus chemotherapy with or without bevacizumab (the Keytruda regimen) demonstrated a statistically significant improvement in overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy with or without bevacizumab in this patient population. additionally, more patients responded to the keytruda regimen, with an objective response rate (orr) of 68% (95% ci, 62-74) versus 50% (95% ci, 44-56), respectively. the safety of keytruda in combination with chemotherapy has been evaluated in 3,123 patients with non-small cell lung cancer (nsclc), head and neck squamous cell carcinoma (hnscc), esophageal carcinoma, triple-negative breast cancer (tnbc) or cervical cancer receiving keytruda 200 mg, 2 mg kg bodyweight (bw) or 10 mg kg bw every three weeks (q3w) in clinical studies.></0.0001)>
"After many years of limited progress in developing new treatment options for persistent, recurrent or metastatic cervical cancer, we saw notable improvements in overall survival in KEYNOTE-826, with a 36% reduction in the risk of death,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “With today’s approval, healthcare providers in the EU will be able to offer certain patients with advanced cervical cancer a long-awaited immunotherapy option that has shown significant improvement in overall survival.
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