- Published in The Lancet, results of the randomized phase III BEATcc academic trial (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030) show that adding immune checkpoint inhibitor atezolizumab to standard of care with bevacizumab and chemotherapy significantly improves progression-free survival and overall survival in patients with metastatic or recurrent cervical cancer who are not candidates for curative-intent surgery and/or radiotherapy.
- This present study is the first to add a PD-L1 inhibitor to standard of care with bevacizumab plus platinum-based doublet chemotherapy in this setting.
- Presented by VHIO’s Ana Oaknin, Principal Investigator and first author of this international study, as an ESMO Virtual Plenary, data show a median overall survival of 32.1 months in patients who received atezolizumab plus standard of care vs. 22.8 months in patients treated with bevacizumab combined with chemotherapy alone.
Patients with metastatic or recurrent cervical cancer not amenable to curative surgery and/or radiotherapy have a poor prognosis with limited treatment options. First-line treatment in this setting consists of combination cisplatin/paclitaxel chemotherapy plus antiangiogenic agent bevacizumab. This therapeutic strategy was approved based on the results of the previous phase III Gynecologic Oncology Group (GOG) 240 trial that showed a median overall survival (OS) of 17 months and progression-free survival (PFS) of 8.2 months.
Directed by Ana Oaknin, Principal Investigator of the Vall d’Hebron Institute of Oncology’s (VHIO) Gynecological Malignancies Group, Medical Oncologist at the Vall d’Hebron University Hospital (HUVH) and an investigator of the Spanish Ovarian Cancer Research Group (GEICO), the open-label phase III BEATcc academic trial (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030) was designed to evaluate the addition of PD-L1 checkpoint inhibitor atezolizumab to standard of care with first-line chemotherapy plus bevacizumab—irrespective of PD-L1 status—versus standard therapy alone.
This international study, results of which have now published in The Lancet (1), included 410 previously untreated patients with metastatic (stage IVB) or recurrent cervical cancer not amenable to curative surgery/radiation who were randomized 1:1 to standard therapy or the combination with the addition of atezolizumab.
“At a median follow-up of 35 months, median overall survival in patients treated with the combination of atezolizumab plus standard therapy was 32.1 months versus 22.8 months in the control arm. This significant improvement is unprecedented in this setting,” says Ana Oaknin, lead author and Principal Investigator of this present study.
She continues, “While the approval of the current standard of care was based on the results of the previous GOG 240 study, the two-year survival rate was less than 40%. Interim OS results of this present study show a two-year survival rate of 60% in patients who received atezolizumab plus bevacizumab and the chemotherapy doublet.”
The BEATcc study investigators also observed significantly improved PFS results. Median PFS was 13.7 months in patients treated with the experimental combination and 10.4 months in the control arm.
“In view of the impact on overall survival, and upon evaluation by the different regulatory authorities and healthcare reimbursement systems, the addition of atezolizumab to standard therapy with bevacizumab and chemotherapy should be considered as a new first line treatment option for patients with metastatic or recurrent cervical cancer,” concludes Oaknin.
Results of the BEATcc study were initially selected as late-breaking data at the 2023 Congress of the European Society for Medical Oncology (ESMO), 20-24 October in Madrid, and subsequently presented by Ana Oaknin as an ESMO Virtual Plenary (2).
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References:
- Ana Oaknin, Laurence Gladieff, Jerónimo Martínez-García, Guillermo Villacampa, Munetaka Takekuma, Ugo De Giorgi, Kristina Lindemann, Linn Woelber, Nicoletta Colombo, Linda Duska, Alexandra Leary, Ana Godoy-Ortiz, Shin Nishio, Antoine Angelergues, Maria Jesús Rubio, Lorena Fariñas-Madrid, Satoshi Yamaguchi, Domenica Lorusso, Isabelle Ray-Coquard, Luis Manso, Florence Joly, Jesús Alarcón, Philippe Follana, Ignacio Romero, Coriolan Lebreton, J Alejandro Pérez-Fidalgo, Mayu Yunokawa, Hanna Dahlstrand, Véronique D’Hondt, Leslie M Randall for the ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG 3030 Investigators. The Lancet, Dec 1 2023 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02405-4/fulltext
- * A. Oaknin, L. Gladieff, J. Martinez-Garcia, G. Villacampa, M. Takekuma, U.F.F. De Giorgi, K. Lindemann, L. Woelber, N. Colombo, L.R. Duska, A. Leary, A. Godoy Ortiz, S. Nishio, A. Angelergues, M.J. Rubio Perez, L. Fariñas Madrid, S. Yamaguchi, D. Lorusso, V. D’Hondt, L. Randall. Primary results from BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030), a randomised phase III trial of first-line atezolizumab (atezo) combined with a platinum doublet and bevacizumab (bev) for metastatic (stage IVB), persistent or recurrent cervical cancer (R/M CC). Published: November 06, 2023DOI:https://doi.org/10.1016/j.annonc.2023.10.694
