Cemiplimab, in combination with platinum-based chemotherapy, has been approved for patients with advanced non–small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
On November 8th, the FDA approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for patients with advanced non–small cell lung cancer (NSCLC).1 The recommended dose is 350 mg intravenously (IV) for a course of 30 minutes every 3 weeks, and the agent comes in a single-dose vial. 2
Patients receiving cemiplimab should not have EGFR, ALK, or ROS1 aberrations. They must also be ineligible for surgery, or definitive chemoradiation, or they must have metastatic disease.
The approval was backed by data from the 16113 trial (NCT03409614), which randomly assigned 466 treatment naïve patients with advanced NSCLC 2:1 to receive either immunochemotherapy or chemotherapy plus placebo. Overall survival (OS), progression-free survival (PFS), and overall response rates (ORR) represented the key outcomes. The median OS was 21.9 months (95% CI, 15.5-not evaluable [NE]) with immunochemotherapy and 13.0 months (95% CI, 11.9-16.1) with chemotherapy plus placebo. The median PFS between the 2 cohorts was 8.2 months (95% CI, 6.4-9.3) and 5.0 months (95% CI, 4.3-6.2), respectively (HR, 0.56; 95% CI, 0.44-0.70; P <.0001). The confirmed ORR was 43% (95% CI, 38%-49%) and 23% (95% CI, 16%-30%), respectively.
Study 16113 was a randomized, multicenter, multination, double-blind active controlled trial. PD-L1 status was not considered in eligibility criteria, however those with EGFR, ALK, or ROS1 harboring tumors, patients who required systemic immunosuppression, or patients with ongoing or recent autoimmune disease, were excluded from the research.
Patients randomized to the experimental arm received cemiplimab plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by a combination of cemiplimab and maintenance chemotherapy. Patients in the control arm received platinum-based chemotherapy plus placebo every 3 weeks for cycles, followed by maintenance with chemotherapy and placebo.
Chemotherapy consisted of any of the following combinations:
In the trial, the most common adverse events (AEs) included alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
Patients who receive cemiplimab may be at risk of immune-mediated AEs, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic AEs, nephritis and renal dysfunction, or solid organ transplant rejection. Liver enzymes creatinine, and thyroid function should be assessed at baseline and periodically throughout treatment.2 Infusion-related reactions may also occur with treatment. In this case, the rate of infusion should be slowed, interrupted, or permanently discontinued, depending on severity.
In addition, patients who undergo allogeneic hematopoietic stem cell transplantation and PD-1/PD-L1 blocking antibodies are at risk of serious complications.
The prescribing label does not offer a recommended dose reduction for cemiplimab. However, in general, grade 3 irAEs warrant holding treatment, and grade 4 irAEs warrant permanent discontinuation. Patients with recurring grade 3 irAEs, or those who are unable to reduce their corticosteroids dose to 10 mg or less within 12 weeks of initiating steroids, will generally need to discontinue treatment.
Cemiplimab injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles. It should be stored in a refrigerator in the original carton. Nurses should not freeze or shake the solution.