Immunotherapy has been shown to improve prognosis

(Vienna, March 22, 2024) Since 1999, the standard treatment for locally advanced cervical cancer consists of external beam radiotherapy with concurrent chemotherapy and subsequent brachytherapy. Since the prognosis of patients remains poor in many cases despite these measures, extensive research is being conducted into new options. An international team including MedUni Vienna showed in a large-scale clinical study that the immunotherapy agent pembrolizumab in combination with chemotherapy results in a statistically significant improvement compared with chemotherapy alone. The results of the study were recently published in the prestigious journal The Lancet.

The phase III, randomized, double-blind, placebo-controlled clinical study was conducted in 176 medical centers in 30 countries, including the Vienna General Hospital and was coordinated by study co-author Stefan Bolterauer (University Clinic of Gynecology at MedUni Vienna, Gynecology Cancer Unit /CCC and Gynecologic Oncology Working Group) in collaboration with the University Radiation Oncology Clinic. Adults with newly diagnosed, locally advanced, and high-risk cervical cancer were randomly selected as subjects. 1,060 participants were also randomly assigned to treatment between June 2020 and December 2022, including 529 to the pembrolizumab chemotherapy group and 531 to the placebo chemotherapy group. As the researchers' observations showed, the combination of pembrolizumab and chemotherapy significantly improved progression-free survival in patients. Overall survival also increased with the addition of monoclonal antibodies, and was 87% in the pembrolizumab chemotherapy group (versus 81% in the placebo group).

“There is an urgent need for effective and targeted treatment options for patients with locally advanced cervical cancer. All data indicate that the effect of chemotherapy can be enhanced by “Immune-stimulating properties of pembrolizumab.” Bolterauer says the research will likely change the current standard of care. “The new combination therapy is expected to be approved.”

Publication: The Lancet
Pembrolizumab or placebo with chemotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomized, double-blind, phase 3 clinical trial
Domenica LoRusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leyva, Pierre Ramos Elias, Alejandro Acevedo, Vladislav Sukhin, Noel Klöven, Andrea J. Pereira de Santana Gomez, Fernando Contreras Mejía, Ari Reyes, Ali Ayhan, Jong-Yun Lee, Valeria Sivits, Flora Zagori, Lucy Gilbert, Jaled Siholi, Ekasit Tharavhitkul, Christina Lindemann, Roberta Lazzari, Chih-Lung Chang, Rudolf Lampe, Hong Zhou, Anna Oknen, Melissa Christians, Stefan PolterauerTomoka Usami, Kan Lee, PhD, Karen Yamada, Sarber Tucker, Steven M. Keefe, Sandro Pignata, Linda R. Duska on behalf of the ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators.
Digital ID: https://doi.org/10.1016/S0140-6736(24)00317-9