Long-term survival benefit of cemiplimab in recurrent/metastatic cervical cancer
Sep 12, 2022 | DelveInsight
Cancer of the Cervix is one of the most common malignancy worldwide. But, the frequency of the occurrence of cervical cancer has decreased because of cytological screening, DNA testing for high-risk human papillomavirus (HPV) types, and HPV vaccination. However, cervical cancer still remains a significant problem because of its poor prognosis and lack of treatment options mainly in the 2nd line patients. Currently, only Keytruda (pembrolizumab) is a preferred category 2A second-line option for patients with recurrent/metastatic cervical cancer as per recommendations from NCCN. The category 2A recommendations are based upon lower-level evidence there is a uniform NCCN consensus that the intervention is appropriate. But, still patients with advanced cervical cancer receive a variety of second-line treatment regimens. Researchers also evaluated the real-world treatment patterns in a cohort of patients with recurrent or metastatic cervical cancer. The results showed that most patients received standard first-line of treatment, but second-line treatment regimens varied, and around 52% of patients did not receive any second-line of treatment.
In several different studies it was also found that patients with advanced or recurrent cervical cancer who progress to first-line chemotherapy have a poor prognosis because of the overall unsatisfactory outcomes of further chemotherapy. Also, for the vast majority of patients with recurrent or advanced disease, palliative chemotherapy is the only treatment option available and cisplatin has been considered as the most effective drug
After nearly 30 months of follow-up, Libtayo (cemiplimab) continued to improve survival compared with chemotherapy for the treatment of patients with recurrent or metastatic cervical cancer after first-line treatment with platinum-based chemotherapy. In the EMPOWER study, investigators analyzed data from 608 patients with recurrent or metastatic cervical cancer after progression on first-line platinum-based chemotherapy. Patients were randomized to receive either 350 mg of cemiplimab intravenously once every 3 weeks (n = 304) or investigator’s choice of single-agent chemotherapy (n = 304). Compared with chemotherapy, the treatment with cemiplimab significantly improved overall survival (OS) (11.7 months vs 8.5 months). Cemiplimab reduced the risk of death by 34% in the overall population, and this effect was also seen in patients with squamous cell carcinoma (10.9 months vs 8.8 months), whose risk for death was reduced by 31%. In patients with adenosquamous carcinoma, cemiplimab treatment reduced the risk of death by 45%, thus increasing OS compared with chemotherapy (13.5 months vs 7.0 months). The investigators also analyzed the OS by PD-L1 status in patients enrolled in either arms. Ana Oaknin called the results from this study “very interesting” as OS at both 12- and 24-months appeared to be improved for those assigned cemiplimab. The median OS for patients in the PD-L1+ group was 12.1 months vs 7.7 months for those assigned chemotherapy, while it was 10.8 months vs 7.0 months for PD-L1- patients.
Conclusion- Cervical cancer has several treatment challenges mainly because of its poor prognosis and lack of treatment options. Also, as previously discussed, the patients on second-line of treatment receive a variety of treatment regimens. So, a proper treatment modality is urgently needed for second-line patients and this data of EMPOWER study of cemiplimab proves beneficial over the currently used investigator’s choice of drugs.
Expert Opinion: “Cemiplimab is the first immunotherapy agent to demonstrate significant and clinically meaningful overall survival [OS] benefit as a second-line monotherapy for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy but without prior immunotherapy.”