Cemiplimab steps up as the first immune-based therapy to improve overall survival in patients with recurrent and/or metastatic cervical cancer

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*, 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 5‑year survival rate is 15%. For women suffering from recurrent and/or metastatic cervical cancer, whose disease has progressed on or after chemotherapy, the few second line systemic therapies available fail to demonstrate any survival benefit. This dismal outlook represents a critical, unmet clinical need.

Results from the second interim analysis of the multi-center, international Phase III EMPOWER** GOG Foundation & ENGOT trial, first authored on behalf of GOG, by Krishnansu S. Tewari Professor and Chief, Division of Gynecologic Oncology, California (USA), show great promise in responding to this need by offering this patient population a novel, more effective immune-based therapeutic avenue.

Co-led – on behalf of ENGOT- by VHIO’s Ana Oaknin, Principal Investigator of our Gynecological Malignancies Group and Senior Author of this present study, the investigators sought 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.

The data show a median 12 month increase in the OS of patients treated with cemiplimab, compared with 8.5 months for those who received chemotherapy. The EMPOWER Investigators also reported a 31% decrease in the risk of death in patients receiving treatment with cemiplimab. Remarkably, this overall survival improvement was observed in all patients irrespective of tumor histology.

Commenting for VHIO’s Global Communications, VHIO’s Ana Oaknin said, “Enrolling 477 patients with recurrent or metastatic squamous cell carcinoma and 131 with adenocarcinoma or adenosquamous 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.”

She added, “Our results show great promise in opening up new and much needed treatment avenues for these patients. Crucially, women suffering from cervical cancer are most frequently diagnosed between the ages of 35 and 44 years of age. We strive to more effectively combat this terrible disease by significantly extending the survival of these younger cancer patients.”

Reflective of the relevance of these results, the European Society for Medical Oncology (ESMO), selected EMPOWER to first outing today, Wednesday, May 12, 2021, as a Virtual Plenary Session via its recently launched web-based platform Accelerating Research to Practice. This educational program broadcasts monthly online presentations of the latest, original scientific data from randomized phase III clinical trials in oncology, or from phase II studies which demonstrate remarkable therapeutic benefit, scientific insight or significant advancement in responding to an unmet clinical need.

Submitted abstracts are reviewed by the ESMO Congress Scientific Chairs and a panel of independent experts. Upon acceptance, they are presented and discussed during live 60-minute sessions, published in ESMO’s flagship journal, Annals of Oncology, and eligible for subsequent presentation at ESMO’s annual Congresses.

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.

**EMPOWER-CERVICAL 1/GOG-3016/ENGOT-CX9: Results of Phase 3 Trial of Cemiplimab vs. Investigator’s Choice (IC) Chemotherapy in Recurrent/Metastatic (R/M) Cervical Carcinoma.