Rationale for Correct Answer
The correct answer is: Cemiplimab
Cemiplimab is the only FDA-approved first line ICI that is not approved for patients carrying a ROS1 alteration. Cemiplimab is FDA-approved as a monotherapy (PD-L1 ≥50%) or in combination with chemotherapy in patients with advanced NSCLC whose tumors do not carry EGFR, ALK, or ROS1 alterations.
- Atezolizumab is FDA approved in patients without EGFR or ALK alterations as a first line monotherapy in patients with high PD-L1 (TC ≥50% or IC ≥10%) or in combination with chemotherapy ± bevacizumab (non-squamous only) without regard to PD-L1 status.
- Nivolumab plus ipilimumab is FDA approved in patients without EGFR or ALK alterations as a first line combination in patients with PD-L1 ≥1% or in combination with chemotherapy without regard to PD-L1 status.
- Pembrolizumab is FDA approved in patients with non-squamous disease that does not carry an EGFR or ALK alteration as a first line monotherapy (PD-L1 ≥1%) or in combination with chemotherapy without regard to PD-L1 status. Pembrolizumab is also approved for use in combination with chemotherapy in lung squamous cell carcinoma without regard to driver mutation or PD-L1 status.
Reference:
U.S. Food & Drug Administration (FDA). Oncology (Cancer) / Hematologic Malignancies Approval Notifications. Reviewed June 20, 2023. Accessed June 20, 2023. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm