European Commission Approves Pembrolizumab Plus Chemotherapy With or Without Bevacizumab for Cervical Cancer

Patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 can receive treatment with pembrolizumab plus chemotherapy with or without bevacizumab following approval by the European Commission.

The European Commission has approved pembrolizumab (Keytruda) plus chemotherapy with or without bevacizumab (Avastin) for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 and who have a combined positive score of 1 or greater, according to a press release from Merck.1

The approval was based on findings from the phase 3 KEYNOTE-826 trial (NCT03635567), which assessed pembrolizumab plus chemotherapy plus or minus bevacizumab vs chemotherapy.2 Patients had an improved overall survival (OS; HR, 0.64; 95% CI, 0.50-0.81; P = .0001), and progression-free survival (HR, 0.62; 95% CI, 0.50-0.77; P <.0001) compared with the placebo arm.

“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 [OS].” Nicoletta Colombo, MD, PhD, associate professor at the University of Milan-Bicocca, and director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy, said in a press release

Pembrolizumab plus chemotherapy with or without bevacizumab has previously been approved by the FDA in October 2021 and was based on the results from the phase 3 KEYNOTE-826 trial.3

References

  1. European Commission approved Merck’s Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, for patients with persistant, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥ 1). News Release. Merck. April 29, 2022. Accessed May 2, 2022. https://bit.ly/3kxze1D
  2. Colombo N, Dubot C, Lorusso D, et al. Pembrolizumab for persistent, recurrent, or metastatic cervical cancer. N Engl J Med. 2021;385(20):1856-1867. doi:10.1056/NEJMoa2112435
  3. FDA approves Merck’s Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, as treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥ 1). News Release. Merck. October 13, 2021. Accessed May 2, 2022. https://bit.ly/3vXoS0u