Nivolumab ± Ipilimumab in Patients With Pretreated Advanced Neuroendocrine Carcinoma: The GCO-001 NIPINEC Randomized Phase II Trial - PubMed
4 hours ago
- #nivolumab
- #neuroendocrine carcinoma
- #ipilimumab
- The GCO-001 NIPINEC trial investigated nivolumab ± ipilimumab as second-/third-line therapy for advanced neuroendocrine carcinoma (NEC) after platinum-based chemotherapy failure.
- 185 patients were enrolled (91 in nivolumab arm, 94 in nivolumab-ipilimumab arm), with 169 analyzed (median age 64.5, 71% male, 91% PS 0-1).
- Primary tumor locations included lungs (50%), colorectal (15%), gastroesophageal (14%), and pancreatic (13%) regions.
- Objective response rate (ORR) at 8 weeks was 7.2% for nivolumab and 14.0% for nivolumab-ipilimumab.
- Best ORR was 9.6% (nivolumab) and 20.9% (nivolumab-ipilimumab), with median progression-free and overall survival around 2 and 6 months in both arms.
- One treatment-related death occurred in the nivolumab arm.
- Grade 3-4 adverse events (≥5%) in the nivolumab-ipilimumab arm included asthenia (13%), gamma-glutamyl transferase increase (10%), alkaline phosphatase increase (9%), dyspnea (7%), and anemia (6%).
- Nivolumab-ipilimumab could be a treatment option for NECs, but further studies are needed to evaluate its use earlier or combined with chemotherapy due to limited benefit.