Keytruda + chemotherapy with or without bevacizumab reduced risk of death by one-third versus chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent or metastatic cervical cancer.

These data were also simultaneously published in the New England Journal of Medicine.

This is the first combination regimen with an anti-PD-1/PD-L1 therapy to improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to chemotherapy with or without bevacizumab as a first-line treatment of persistent, recurrent or metastatic cervical cancer.

Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab (Keytruda plus chemo ± bev) reduced the risk of death by one-third, or 33% (HR=0.67 [95% CI, 0.54-0.84]; p<0.001), versus chemotherapy with or without bevacizumab (chemo ± bev). median os for keytruda plus chemo ± bev was 24.4 months (95% ci, 19.2-not reached [nr]) compared to 16.5 months (95% ci, 14.5-19.4) for chemo ± bev. for the dual primary endpoint of pfs, median pfs (hr="0.65" [95% ci, 0.53-0.79]; p><0.001) was 10.4 months (95% ci, 9.1-12.1) in those treated with keytruda plus chemo ± bev and 8.2 months (95% ci, 6.4-8.4) among those treated with chemo ± bev. in the trial, keytruda plus chemo ± bev showed an orr of 65.9% (95% ci, 60.3-71.2), and chemo ± bev showed an orr of 50.8% (95% ci, 45.1-56.5). median duration of response (dor) was 18.0 months (range, 1.3+ to 24.2+) in the keytruda plus chemo ± bev arm and 10.4 months (range, 1.5+ to 22.0+) in the chemo ± bev arm. the results were consistent with or without bevacizumab use.></0.001)></0.001),>

“Cervical cancer continues to be the second leading cause of cancer-related death in young women between 15 and 44 years of age, and historically women have faced a poor prognosis when diagnosed at later stages,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, European Institute of Oncology in Milan, Italy. “These important survival results support Keytruda plus chemotherapy with or without bevacizumab as a potential new treatment option in the first-line setting for patients with persistent, recurrent or metastatic cervical cancer.”

Treatment-related adverse events (TRAEs) Grade, greater than 3 ,occurred in 68.4% of patients in the Keytruda plus chemo ± bev arm and 64.1% of patients in the chemo ± bev arm. Patients in the Keytruda plus chemo ± bev arm had a longer duration of treatment than those in the chemo ± bev arm. In the Keytruda plus chemo ± bev arm, TRAEs led to discontinuation of any treatment in 31.3% of patients and of all treatment in 3.3% of patients. In the chemo ± bev arm, TRAEs led to discontinuation of any treatment in 22.3% of patients and of all treatment in 1.9% of patients.

See- "Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer"-_Nicoletta Colombo, M.D., Ph.D., Coraline Dubot, M.D., Domenica Lorusso, M.D., Ph.D., M. Valeria Caceres, M.D., Ph.D., Kosei Hasegawa, M.D., Ph.D., et al., for the KEYNOTE-826 Investigators.September 18, 2021 DOI: 10.1056/NEJMoa2112435.