(Vienna, 22 March 2024) Since 1999, the standard treatment for locally advanced cervical cancer has consisted of external radiotherapy followed by chemotherapy and brachytherapy. As the prognosis for patients is still poor in many cases despite these measures, intensive research is being conducted into new options. In a large-scale clinical trial, an international team involving MedUni Vienna has shown that the immunotherapeutic agent pembrolizumab in combination with chemoradiotherapy leads to a statistically significant improvement compared to chemoradiotherapy alone. The study results were recently published in the leading journal "The Lancet".
The randomised, double-blind, placebo-controlled phase 3 clinical trial was carried out at 176 medical centres in 30 countries, including Vienna General Hospital under the coordination of study co-author Stephan Polterauer (MedUni Vienna's Department of Obstetrics and Gynecology, Gynecologic Cancer Unit/CCC and Gynecologic Oncology Working Group) in collaboration with the Department of Radiation Oncology. Adults with newly diagnosed, locally advanced high-risk cervical cancer were randomly selected as test subjects. The 1060 participants were also randomly assigned to treatment between June 2020 and December 2022, 529 of them to the pembrolizumab chemoradiotherapy group and 531 to the placebo chemoradiotherapy group. As the researchers' observations showed, the combination of pembrolizumab and chemoradiotherapy significantly improved progression-free survival in the patients. Overall survival also increased with the addition of the monoclonal antibody and was 87 per cent in the pembrolizumab chemoradiotherapy group (compared to 81 per cent in the placebo chemoradiotherapy group).
"There is an urgent need for effective, targeted treatment options for patients with locally advanced cervical cancer. All data indicate that the effect of chemoradiotherapy can be enhanced by the immunostimulatory properties of pembrolizumab," reports Stephan Polterauer on the key finding from one of the largest studies in patients with cervical cancer. According to Polterauer, the research work is likely to change the current standard of treatment. "Approval of the new combination therapy is expected."
Publication: The Lancet
Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial
Domenica Lorusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leiva, Pier Ramos-Elias, Alejandro Acevedo, Vladyslav Sukhin, Noelle Cloven, Andrea J Pereira de Santana Gomes, Fernando Contreras Mejía, Ari Reiss, Ali Ayhan, Jung-Yun Lee, Valeriya Saevets, Flora Zagouri, Lucy Gilbert, Jalid Sehouli, Ekkasit Tharavichitkul, Kristina Lindemann, Roberta Lazzari,Chih-Long Chang, Rudolf Lampé, Hong Zhu, Ana Oaknin, Melissa Christiaens, Stephan Polterauer, Tomoka Usami, Kan Li, PhD, Karin Yamada, Sarper Toker, Stephen M Keefe, Sandro Pignata, Linda R Duska on behalf of theENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
DOI: https://doi.org/10.1016/S0140-6736(24)00317-9