Nivolumab monotherapy has shown survival benefit in patients (pts) with different tumors, including melanoma, lung cancer, renal cell carcinoma and head and neck cancer. The experience of pts and physicians in routine clinical practice is often different from that in a controlled clinical trial setting. Here, we report efficacy and safety of nivolumab monotherapy in pts with non-squamous non-small cell lung cancer (NSCLC) treated in the nivolumab Expanded Access Programme in Italy.
Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Squamous NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events.
In total, 1588 Italian pts participated in the EAP across 168 centers. Baseline characteristics of pts were representative of the population with non-squamous NSCLC, in the advanced disease setting. With a median follow-up of 7.8 months (1-21.9) and a median of 7 doses, the overall response rate (ORR) was 18%, including 10 pts (
To date, this is the largest clinical experience with nivolumab in a real-world setting. These preliminary EAP data confirm that nivolumab seems to be an effective and safe therapy for pre-treated patients with non-squamous NCSLC, supporting its use in current clinical practice.
Clinical trial identification
Legal entity responsible for the study
Prof. Lucio Crinò
F. Grossi: Consulting or Advisory Role: Bristol-Myers Squibb, Boehringer Ingelheim, Merck Sharp & Dohme, Pierre Fabre, AstraZeneca, Roche. F. De Marinis: Consulting or Advisory Role: Bristol-Myers Squibb, AstraZeneca, Roche. H.J. Soto Parra: Consulting or Advisory Role: Bristol-Myers Squibb, Lilly. F. Cappuzzo: Consulting or Advisory Role: Bristol-Myers Squibb, Pfizer, AstraZeneca, Roche. M. Tiseo: Consulting or Advisory Role: Bristol-Myers Squibb, Boehringer Ingelheim, Lilly, Merck Sharp & Dohme, Otsuka, Pierre Fabre, AstraZeneca, Novartis Pharma. M.R. Migliorino: Honoraria: Bristol-Myers Squibb, Boehringer Ingelheim, AstraZeneca Consulting or Advisory Role: Bristol-Myers Squibb, Boehringer Ingelheim, AstraZeneca. G. Tonini: Consulting or Advisory Role, Pierre Fabre, Molteni Farmaceutici, Novartis Pharma KK, Roche. F. Cognetti: Consulting or Advisory Role: AMtene Research Funding: Company: Genomic Health A. Scoppola: Travel, Accommodations, Expenses: IBSA. E. Cortesi: Honoraria: Janssen Corp Consulting or Advisory Role: Sirtex Medical. All other authors have declared no conflicts of interest.