Treatment with Libtayo may improve survival over a 30-month period with no new side effects in patients with recurrent or metastatic cervical cancer, opening the doors for an immunotherapy option for these patients.
Findings from a long-term survival analysis demonstrated that patients with recurrent or metastatic cervical cancer treated with second-line Libtayo (cemiplimab) had sustained improvements in survival regardless of PD-L1 status.
Results from this study, which were presented at the 2022 ESMO Congress, showed that the use of Libtayo may provide patients with recurrent or metastatic cervical cancer with a viable treatment option if they previously underwent first-line chemotherapy.
“(Libtayo) is the first immunotherapy agent to demonstrate significant and clinically meaningful overall survival benefit as a second-line monotherapy for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy but without prior immunotherapy,” said Dr. Ana Oaknin, head of the gynecological tumor unit and full-time senior attending physician in the Medical Oncology Department at the Vall d’Hebron University Hospital in Barcelona, Spain, during the presentation.
CURE® spoke with Dr. Krishnansu S. Tewari, a division director and The Philip J. DiSaia, MD Endowed Chair in Gynecologic Oncology at the University of California, Irvine, who was also a researcher on this trial. He highlighted the importance of this specific analysis, which was performed to confirm whether the improvement in overall survival (the time a patient is still alive after treatment for cancer) at the original analysis of the data was sustained in this analysis.
“(Libtayo) is the only option for second-line therapy of women with recurrent cervical cancer that had been validated in a prospective, randomized phase 3 clinical trial,” he said.
In this EMPOWER-Cervical 1 study, the investigators analyzed data from 608 patients with recurrent or metastatic cervical cancer after progression on first-line platinum-based chemotherapy. Patients were assigned either 350 milligrams of Libtayo or single-agent chemotherapy.
The primary goal of the study was to assess overall survival. The analysis was performed after 363 overall survival events occurred over a median follow-up of 30.2 months.
Compared with chemotherapy, treatment with Libtayo significantly improved overall survival (11.7 months versus 8.5 months, respectively). The use of Libtayo also reduced the risk for death by 34% in the overall population. This effect was also seen in patients with squamous cell carcinoma (10.9 months versus 8.8 months), whose risk for death was reduced by 31%.
In patients with adenosquamous carcinoma, Libtayo treatment reduced the risk for death by 45%, thus increasing overall survival compared with chemotherapy (13.5 months versus 7 months).
Researchers also assessed overall survival by PD-L1 status in patients assigned Libtayo (304 patients) or chemotherapy (304 patients). PD-L1 is a protein that, when it binds to the PD-1 protein, can stop T cells from killing cancer cells. Treatment with a drug like Libtayo prevents PD-L1 from binding to PD-1, which then allows the immune system to destroy the diseased cells.
Oaknin called the results from this exploratory analysis of PD-L1 status “very interesting,” as 12-month and 24-month overall survival were longer for those assigned Libtayo. In particular, the median overall survival for patients in the PD-L1-positive group was 12.1 months versus 7.7 months for those assigned chemotherapy. For patients with PD-L1-negative status, the median overall survival was 10.8 months compared with 7 months, respectively.
The overall response rate (percentage of patients whose disease partially or completely responds to treatment) was 16.4% in the Libtayo group verdus 6.3% in the chemotherapy group.
“This pattern was repeated regardless of PD-L1 status,” Oaknin said during the presentation.
There were no new side effects with Libtayo compared with chemotherapy. Oaknin mentioned that the safety profile of Libtayo was consistent with other anti-PD-L1 agents.
“Anti-PD-1 therapy using (Libtayo) is tolerable and beneficial for patients in need of second-line therapy for recurrent cervical cancer,” Tewari told CURE®.
Although the findings from this study are positive, Tewari said that more research is needed in this area.
“We need to determine whether novel combinations of other medicines added to (Libtayo) can improve survival, particularly among women who have been treated in the first-line setting for recurrent cervical cancer with other anti-PD-1 therapy (i.e., pembrolizumab [Keytruda]),” he concluded.
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