medwireNews: The EMPOWER-Cervical 1 trial findings demonstrate a significant survival advantage with cemiplimab versus investigator’s choice of chemotherapy for women with recurrent or metastatic cervical cancer that has progressed after treatment with platinum-containing chemotherapy.
Patients given the PD-1 inhibitor in the phase 3 study “showed a benefit with respect to overall survival [OS] that was significant and clinically meaningful”, say Krishnansu Tewari (University of California, Irvine, USA) and co-authors in The New England Journal of Medicine.
The trial recruited patients with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma who had previously received bevacizumab and paclitaxel but not PD-1 or PD-L1 inhibitor therapy.
At the planned interim analysis, median OS was 12.0 months for the 304 women who were randomly assigned to receive cemiplimab 350 mg every 3 weeks. This was significantly longer than the 8.5 months achieved by the 304 women who instead were given single-agent pemetrexed, topotecan, irinotecan, gemcitabine or vinorelbine, with a hazard ratio (HR) for death of 0.69.
Median OS was also significantly longer for the cemiplimab-treated patients than controls when assessing subgroups of patients with squamous cell carcinoma (11.1 vs 8.8 months; HR=0.73) and adenocarcinoma/adenosquamous carcinoma (13.3 vs 7.0 months; HR=0.56).
Median progression-free survival appeared to be comparable for cemiplimab and chemotherapy in the full study population (2.8 vs 2.9 months), the squamous cell carcinoma subgroup (2.8 vs 2.9 months) and the adenocarcinoma/adenosquamous subgroup (2.7 vs 2.8 months).
However, the HRs for the full population and the squamous cell carcinoma group were a significant 0.75 and 0.71 in favour of the PD-1 inhibitor and this “was driven by durable separation of the curves after median progression-free survival was reached”, the researchers explain.
Tewari et al also investigated the impact of PD-L1 tumour expression on clinical outcome in 126 cemiplimab-treated patients and 128 controls, noting that expression of 1% or higher was more common among the squamous cell carcinoma patients than those with adenocarcinoma or adenosquamous carcinoma (70.7 vs 32.6%).
Among patients with PD-L1 expression of at least 1%, median OS was significantly higher with cemiplimab than chemotherapy (13.9 vs 9.3 months; HR=0.70), whereas no significant difference was found between the treatment groups for those with less than 1% expression (7.7 vs 6.7 months).
Nevertheless, the investigators emphasize that cemiplimab achieved objective responses in both patients with and without PD-L1 tumour expression (18% of 82 vs 11% of 44 patients), indicating “that some PD-L1–negative patients may nevertheless have a response to cemiplimab.”
Patients given cemiplimab had a longer median duration of treatment than their chemotherapy-treated counterparts (15.2 vs 10.1 weeks) and experienced fewer adverse events at any grade (88.3 vs 91.4%) and at grade 3 or higher (45.0 vs 53.4%).
Tewari and co-authors therefore conclude “that some women with recurrent cervical cancer may benefit from therapy with cemiplimab.”
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This independent news story was supported by an educational grant from L’Institut Servier, Suresnes, France.