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Cervical Cancer: Immunotherapy for All?
Despite recent improvements in clinical outcomes for women with advanced cervical cancer, which is now routinely treated with a combination of platinum-based agents, taxanes, and bevacizumab, recurrences are inevitable and treatment options remain limited. Few chemotherapy agents have modest activity in the recurrent setting and the anti–PD-1 antibody pembrolizumab was approved only for patients with PD-L1 positive tumors. However, the clinical activity of immune checkpoint inhibitors has not been compared to that of chemotherapy. This gap in knowledge was addressed in the phase 3, industry-sponsored EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial, which compared single-agent chemotherapy to cemiplimab in women with recurrent cervical cancer (cemiplimab is not yet FDA approved for use in this setting).
In the trial, 608 women were randomized to receive either cemiplimab (350 mg intravenously every 3 weeks) or physician's choice of single-agent chemotherapy (gemcitabine, topotecan, pemetrexed, irinotecan, or vinorelbine). Roughly 60% of patients had received a single prior line of chemotherapy and 40% had received more than one prior regimen. Half the patients had received prior bevacizumab.
Overall survival, the primary endpoint, was significantly longer in the cemiplimab group than the chemotherapy group (median, 12.0 vs. 8.5 months; P<0.001). A survival benefit with cemiplimab was observed irrespective of histological type (adenocarcinoma vs. squamous cell carcinoma) or PD-L1 expression status. Serious adverse events occurred in roughly 30% of patients in both treatment groups.
These results support inclusion of cemiplimab in the standard of care for treating recurrent cervical cancer. Outperforming physician's-choice chemotherapy irrespective of PD-L1 expression, this new agent changes the clinical approach for this deadly cancer. However, given the recently reported results from KEYNOTE-826 demonstrating superiority of a four-drug regimen (cisplatin, paclitaxel, bevacizumab, pembrolizumab) for women with metastatic PD-L1–positive cervical cancer, one question looms large over the field: Should immune checkpoint inhibitors be used upfront or reserved for the time of recurrence?
Daniela Matei, MD, is Chief of Reproductive Science in Medicine, Department of Obstetrics and Gynecology, and Diana, Princess of Wales Professor of Cancer Research, Feinberg School of Medicine, Northwestern University.
Tewari KS et al.
Title: Survival with cemiplimab in recurrent cervical cancer.
Source: N Engl J Med 2022 Feb 10; [e-pub]. (Abstract/FREE Full Text)