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Seven provinces have agreed to reimburse cemiplimab for the treatment of patients with advanced non–small cell lung cancer and basal cell carcinoma.
Cemiplimab-rwlc (Libtayo) is now reimbursed by public drug programs in Ontario, British Columbia, Saskatchewan, Nova Scotia, Newfoundland and Labrador, and New Brunswick for adults with advanced non–small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC).1
The exact reimbursement indications in lung cancer specify cemiplimab as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC and a PD-L1 tumor proportion score (TPS) of 50% or greater, as determined by a validated test, with no EGFR, ALK, or ROS1 aberrations, and who are not candidates for surgical resection or definitive chemoradiation; and in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have no EGFR, ALK, or ROS1 aberrations, and who are not candidates for surgical resection or definitive chemoradiation.2
Cemiplimab may also be reimbursed when used for the treatment of adult patients with locally advanced BCC with prior exposure to a hedgehog pathway inhibitor.3
“It’s incredibly meaningful that [cemiplimab] is now available to eligible patients with advanced NSCLC and locally advanced BCC through public drug programs in these provinces,” Jayne Paterson, Oncology Country Manager of Regeneron Canada, said in a news release.1 “We look forward to working with the remaining public drug programs to secure access to [cemiplimab] for all Canadians who could benefit from it.”
In addition, cemiplimab is also now reimbursed in Alberta for the NSCLC combination therapy indication and locally advanced BCC indication. Cemiplimab is also now able to be reimbursed in Québec by Régie de l’assurance maladie du Québec for adults with advanced NSCLC in the single-agent and combination therapy indications.
“NSCLC is a devastating disease that affects many Canadians and their families. The availability of [cemiplimab] provides an additional, much-needed therapeutic option for those whose disease is at an advanced stage,” Barbara Melosky, MD, FRCP(C), clinical professor of medicine at the University of British Columbia in Vancouver, added in the news release.
The reimbursements for cemiplimab in advanced NSCLC and locally advanced BCC are based on data from the phase 3 EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614), and phase 2 EMPOWER-BCC 1 (NCT03132636) trials, respectively.4-6
Key findings from EMPOWER-Lung 1, which evaluated first-line cemiplimab (n = 357) vs investigator’s choice of chemotherapy (n = 355) in patients with advanced NSCLC and PD-L1 TPS of 50% or greater, showed that with 35 months of follow-up, those with a PD-L1 expression of at least 50% experienced a median overall survival (OS) of 26.1 months (95% CI, 22.1-31.8) with cemiplimab vs 13.3 months (95% CI, 10.5-16.2) with chemotherapy (HR, 0.57; 95% CI, 0.46-0.71; P < .0001). The median progression-free survival (PFS) was 8.1 months (95% CI, 6.2-8.8) with cemiplimab vs 5.3 months (95% CI, 4.3-6.1) with chemotherapy (HR, 0.51; 95% CI, 0.42-0.62; P < .0001).4 Updated findings from the trial, which were analyzed with median follow-up of 59.6 months, indicated that the median OS (HR, 0.59; 95% CI, 0.48-0.72) and PFS (HR, 0.50, 95% CI, 0.41-0.61) remained unchanged.5
Long-term data from EMPOWER-Lung 3, which compared cemiplimab plus chemotherapy (n = 312) vs chemotherapy alone (n = 154) in treatment-naive patients with advanced NSCLC, showed that with median follow-up of 60.9 months, those who received cemiplimab plus chemotherapy experienced a median OS of 21.1 months (95% CI, 15.9-23.9) vs 12.9 months (95% CI, 10.6-16.1) in the chemotherapy alone arm (HR, 0.662; 95% CI, 0.531-0.825; P = .0002). The median PFS with cemiplimab was 8.2 months (95% CI, 6.5-9.0) vs 5.5 months (95% CI, 4.3-6.2) with chemotherapy alone (HR, 0.579; 95% CI, 0.467-0.718; P < .0001).6
Key findings from EMPOWER-BCC 1 showed that with median follow-up of 8.4 months, treatment with cemiplimab led to an objective response rate per independent central review (ICR) of 24.1% (95% CI, 13.5%-37.6%) in patients with metastatic BCC who progressed on or were intolerant to hedgehog inhibitors (n = 54). The median OS was not reached and the median PFS per ICR was 8.3 months (95% CI, 4.2-15.9).7
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