Survival was 12.0 months versus 8.5 months among women who received the investigator's choice of chemotherapy (P<0.001), researchers report in the New England Journal of Medicine.
"The survival benefit with cemiplimab was observed in patients with squamous-cell carcinoma and in those with adenocarcinoma or adenosquamous carcinoma," Dr. Krishnansu Tewari of the University of California, Irvine, and colleagues write.
The median progression-free survival among the 304 patients who received cemiplimab was 2.8 months versus 2.9 months for the 304 volunteers in the control group, a non-significant difference.
An objective response was seen in 18% of cemiplimab patients with PD-L1 expression greater than or equal to 1%, 11% with PD-L1 expression of less than 1%, 16.4% overall, and 6.3% in the chemotherapy group.
The findings apply to patients in whom first-line platinum-containing chemotherapy failed.
Side effects rated grade-3 or higher were seen in 45.0% of cemiplimab patients and 53.4% who got chemotherapy.
Regeneron Pharmaceutical and Sanofi paid for the study.
The drug, sold under the brand name Libtayo, is approved in the U.S. for patients with non-small cell lung cancer, basal-cell carcinoma and advanced cutaneous squamous-cell carcinoma.
The results were initially released in May at the annual meeting of the European Society of Medical Oncology.
SOURCE: https://bit.ly/3GshQ6Y The New England Journal of Medicine, online February 9, 2022.
By Reuters Staff
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