A Phase 3B/4 Safety Trial of Nivolumab (NIVO) in Patients with Advanced or Metastatic NSCLC
Nivolumab (NIVO), a fully human IgG4 programmed death-1 (PD-1), immune checkpoint inhibitor antibody, has demonstrated durable responses and tolerability in heavily pretreated patients with advanced NSCLC. Conducted mostly in community-based oncology centers, this ongoing trial explored the safety of NIVO in previously treated NSCLC patients.1 Eligible patients were enrolled in 4 subgroups: 1) squamous cell (SQ), performance status (PS) 0–1, ?2 prior therapies; 2) SQ, PS 0–1, 1 prior therapy; 3) nonsquamous (NSQ), PS 0–1, ?1 prior therapy; and 4) SQ or NSQ, PS 2, ?1 prior therapy. Patients received NIVO 3 mg/kg IV every 2 weeks either until progressive disease (PD)/unacceptable toxicity (Cohort A), or for 1 year with the possibility of retreatment upon disease progression (Cohort B). The primary objective was to estimate the incidence of high grade (Grade 3–4 and 5) treatment-related adverse events (TRAEs); exploratory efficacy assessments include overall response rate, progression-free survival, and overall survival. A total of 226 patients were treated and 51 patients had evaluable radiographic tumor assessments at week 9. The safety and tolerability of NIVO were consistent with prior NIVO experience and no new safety signals were identified in this trial. NIVO TRAEs included interstitial nephritis, hypo- or hyperthyroidism, diarrhea, autoimmune hepatitis, pneumonitis, rash, and infusion reactions; most TRAEs were <Grade 3 and unrelated to performance status. Immune-related toxicities were manageable in a community practice setting using previously developed safety algorithms. Initial efficacy results showed an objective response rate (ORR) of 56%, with 12% partial responders and 44% with stable disease. Early data from this large multicenter trial suggests that patients with pretreated advanced NSCLC benefit from NIVO therapy, even in a community practice setting.
- Bauer TM, et al. ASCO 2015. Abstract 3013.