- Published in the New England Journal of Medicine, results of the phase III EMPOWER trial show improved survival with the PD-1 blocking antibody cemiplimab in recurrent cervical cancer.
- Overall survival was strikingly longer with cemiplimab immunotherapy than with single-agent chemotherapy among patients with disease progression after first-line platinum-containing therapy.
- Showing significant and clinically meaningful survival benefits, this study could potentially ring in cemiplimab immunotherapy as a new treatment option for patients with recurrent/metastatic cervical cancer after platinum failure.
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women globally. The GLOBOCAN 2020 report on cancer incidence and mortality (1), produced by the International Agency for Research on Cancer (IARC), estimates that there were 604,000 new cases of cervical cancer and 342,000 deaths from this disease worldwide in 2020.
Patients with cervical cancer who have been diagnosed early and received standard therapy, have an excellent prognosis with an overall survival (OS) rate of 90-95%. In patients with advanced disease, however, the prognosis is poor with a 5‑year survival rate of 15%. For women suffering from recurrent and/or metastatic cervical cancer, whose disease has progressed on or after platinum-based chemotherapy, the few second line systemic therapies available fail to demonstrate any survival benefit. Improving outcomes for these patients therefore represents a critical, unmet clinical need.
Now, results from the multi-center, international Phase III EMPOWER Gynecologic Oncology Group (GOG) & European Network for Gynaecological Oncological Trial groups (ENGOT) study, published as an original article in The New England Journal of Medicine (2), show promise in improving survival and could potentially ring in the PD-1 blocking antibody cemiplimab as a more effective treatment option for this particular patient population.
First authored on behalf of GOG, by Krishnansu S. Tewari Professor and Chief, Division of Gynecologic Oncology, California (USA), and co-led on behalf of ENGOT by VHIO’s Ana Oaknin, Principal Investigator of our Gynecological Malignancies Group, this study was designed to assess the efficacy of PD-1 inhibitor, cemiplimab, as monotherapy, compared with physician-choice chemotherapy in improving clinical outcomes, measured by overall survival (OS) as the primary endpoint.
“Cemiplimab, approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in patients with relapsed cervical cancer. We therefore sought to establish the survival benefit of this immune-based contender over treatment with single agent chemotherapy,” observed Ana Oaknin, a Senior Author of this present study.
In this phase III open-label trial, 608 women with recurrent/metastatic cervical cancer were randomly assigned to receive cemiplimab or the investigator’s choice of single agent chemotherapy. In the overall trial population median OS was longer in the cemiplimab group than in the chemotherapy group – 12 months versus 8.5 months. Strikingly, the data show that the OS benefit was consistent in both histologic subgroups; squamous-cell carcinoma (177 patients) and adenocarcinoma (131 patients).
As compared with chemotherapy, the GOG-ENGOT Investigators also report a 31% lower risk of death in the overall population patients receiving cemiplimab, and a 27% lower risk of death in patients with squamous-cell carcinoma.
“This study is the largest clinical trial to-date in this patient population. Furthermore, cemiplimab is the first immune-based therapy to show an improvement in overall survival in patients whose disease progressed on first line treatment with platinum-based chemotherapy,” added Ana Oaknin.
She concluded, “Our results point to the promise of cemiplimab as a new and much needed treatment option for some of these patients. Considering that women suffering from cervical cancer are most frequently diagnosed between the ages of 35 and 44 years, we must collectively strive to extend the survival of these younger patients.”
###
References:
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4. doi: 10.3322/caac.21660. Epub ahead of print. PMID: 33538338.
- Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, Kim YM, Lisyanskaya A, Samouëlian V, Lorusso D, Damian F, Chang CL, Gotovkin EA, Takahashi S, Ramone D, Pikiel J, Maćkowiak-Matejczyk B, Guerra Alía EM, Colombo N, Makarova Y, Rischin D, Lheureux S, Hasegawa K, Fujiwara K, Li J, Jamil S, Jankovic V, Chen CI, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Mathias M, Fury MG, Oaknin A; Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555.
