Is Yervoy Approved for Lung Cancer?
Yervoy (ipilimumab), from Bristol Myers Squibb, is FDA-approved for non-small cell lung cancer (NSCLC) in combination with Opdivo (nivolumab). The approval covers first-line treatment of metastatic NSCLC with no EGFR or ALK mutations, using the Opdivo-Yervoy regimen plus chemotherapy. It received accelerated approval in 2020 based on the CheckMate 227 trial, which showed improved overall survival versus chemotherapy alone.[1][2]
How Does Yervoy Work in Lung Cancer Treatment?
Yervoy is a CTLA-4 inhibitor that boosts T-cell activation against cancer cells. In NSCLC, it pairs with Opdivo (a PD-1 inhibitor) to enhance immune response. The dual immunotherapy approach targets different immune checkpoints, showing 4-year survival rates around 20-30% in trials for PD-L1-positive patients, outperforming chemo in certain subgroups.[3]
Which Lung Cancer Patients Qualify?
Eligible patients have advanced or metastatic NSCLC without targetable mutations (EGFR, ALK, ROS1). It's not approved for small cell lung cancer (SCLC). Dosing is intravenous: Yervoy 1 mg/kg every 6 weeks with Opdivo 360 mg every 3 weeks, for up to 2 years or progression.[1][4]
What Trial Data Supports This?
CheckMate 227 (phase 3) enrolled 1,739 patients; the combo improved survival (17.1 months median vs. 14.9 months for chemo). CheckMate 9LA added chemo and extended survival to 15.8 months vs. 11.0 months. Benefits were consistent across PD-L1 levels.[2][3]
Common Side Effects and Risks
Immune-related adverse events occur in over 90% of patients, including fatigue, rash, diarrhea, and severe issues like colitis, hepatitis, or pneumonitis (up to 10% grade 3-4). Monitoring and steroids are standard for management. Discontinuation happens in about 30%.[1][4]
How Does It Compare to Other Lung Cancer Immunotherapies?
Versus Keytruda (pembrolizumab) plus chemo, Opdivo-Yervoy shows similar survival but higher toxicity. It's an alternative for PD-L1-low patients where Keytruda monotherapy fails. No head-to-head trials exist.[3]
Off-Label Use or Ongoing Trials?
No FDA approval for SCLC or adjuvant NSCLC, but trials explore Yervoy in earlier stages (e.g., neoadjuvant with CheckMate 77T) and combinations. Off-label use is rare due to strong approved options.[5]
[1]: FDA Label for Yervoy
[2]: CheckMate 227 Results
[3]: CheckMate 9LA Data
[4]: NCCN NSCLC Guidelines
[5]: ClinicalTrials.gov Search for Ipilimumab NSCLC