The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for monotherapy with the drug in these two advanced cancers, and approval usually follows in about 6 weeks.
Cemiplimab is the first immunotherapy to receive a positive CHMP opinion for BCC, according to the companies developing the drug, Regeneron and Sanofi, which sponsored the trial.
Cemiplimab has been available since 2018 in the European Union and US for the treatment of certain patients with advanced cutaneous squamous cell carcinoma.
Details of NSCLC Indication
The NSCLC indication that was greenlit in Europe is for first-line monotherapy for patients with locally advanced or metastatic disease who are not candidates for definitive chemoradiotherapy and whose tumors have a high expression of programmed cell death–ligand-1 (PD-L1; tumor proportion score > 50) with no EGFR, ALK, or ROS1 aberrations.
It is based on results that showed a survival benefit in the phase 3, open-label EMPOWER-Lung 1 trial, which randomized 710 patients with previously untreated metastatic NSCLC (stage IV) or locally advanced NSCLC (stage IIIB/C) to receive either cemiplimab or platinum-doublet chemotherapy.
Patients in the experimental group received cemiplimab 350 mg intravenously every 3 weeks.
Median overall survival (OS) was 22.1 months with cemiplimab vs 14.3 months with chemotherapy (hazard ratio [HR], 0.68; P = .0022).
Median progression-free survival (PFS) was 6.2 months vs 5.6 months with chemotherapy (HR, 0.59; P < .0001).
In 2020, the trial was stopped early due to the significant improvement in OS.
The confirmed overall response rate was 37% for the cemiplimab group versus 21% for the chemotherapy group.
The most common adverse reactions (> 10%) with cemiplimab were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.
Details of BCC Indication
The European panel also recommended approval of cemiplimab for the treatment of patients with locally advanced or metastatic BCC who have progressed on or are intolerant to a hedgehog pathway inhibitor.
The positive opinion is based on response rate results from an open-label, single-arm, phase 2 trial in 38 outpatient clinics in Canada, Europe, and the United States. Data from the study, known as EMPOWER-BCC 1, were published this month in Lancet Oncology.
An objective response, which was the study's primary endpoint, was observed in 26 (31%) of the 84 enrolled patients. Median duration of follow-up was 15 months.
Grade 3-4 treatment-emergent adverse events occurred in 40 (48%) patients. The most common were hypertension in four patients (5%) and colitis in four (5%). Serious treatment-emergent adverse events occurred in 29 (35%). There were no treatment-related deaths.
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Cite this: EU Panel Likes Monotherapy Cemiplimab for Two Cancers - Medscape - May 25, 2021.