- The combination of nivolumab (NIVO) plus low-dose ipilimumab (IPI) could offer a chemotherapy-free option for first-line treatment of patients with advanced NSCLC regardless of PD-L1 status.
Why this matters
- CheckMate 227 is the first trial showing that NIVO+IPI prolongs survival as compared with chemotherapy in treatment-naïve patients with metastatic NSCLC.
- There are already several front-line treatment options but this is another chemotherapy-sparing option.
- Phase 3 CheckMate 227 study included treatment-naïve patients with stage IV or recurrent disease.
- Part 1 of this multipart study was designed to evaluate different NIVO-based regimens versus chemotherapy in two different PD-L1 subgroups.
- Both patients with PD-L1 ≥1% (n=1189) and PD-L1
- Funding: Bristol-Myers Squibb.
- OS was significantly longer with NIVO+IPI compared with chemotherapy.
- Patients with PD-L1 ≥1% treated with NIVO+IPI had a median OS of 17.1 months compared with 14.9 months in the chemotherapy group (P=0.007).
- OS benefit was also observed in patients with PD-L1
- PFS, objective response rates, and duration of response were all greater with NIVO+IPI compared to chemotherapy in all subgroups.
- Grade 3-4 treatment-related adverse events rate was 33% in those treated with NIVO+IPI, 19% with NIVO, and 36% with chemotherapy.
- The NIVO+IPI combination was not compared with the current standards of care because the study started before chemotherapy/immunotherapy or immunotherapy alone was approved for the front-line treatment of NSCLC.
- “We don’t yet know if the findings are practice-changing. CheckMate 227 was started before the introduction of current standards of care. The comparison was chemotherapy alone, but this is no longer the standard for patients with metastatic NSCLC,” said Marina Chiara Garassino, Istituto Nazionale Tumori, Milan, Italy who was not involved with the study.