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.