Abstract 15P
Background
The trial was terminated at a pre-planned interim futility analysis, after randomisation of 217 patients (242 planned) and observing 33% of expected events. No statistically significant OS benefit was noted for nivolumab-ipilimumab (NI) over platinum-based chemotherapy (PBC) in the first analysis. Here, we present updated OS data, along with additional safety and QoL findings.
Methods
This open-label, multicentre, randomised, controlled, phase III trial included stage IV NSCLC with no known oncogenic alterations judged eligible to receive PBC, without contra indications to NI, either aged ≥70 years with PS of 0–2 or < 70 years with PS of 2 to receive NI or PBC. The primary endpoint was OS, with safety and QoL as secondary endpoints.
Results
After a median follow up of 52.9 (0.03–67.7) months, median OS was 14·7 (95% CI 8·0–20.5·7) months for NI and 9·9 (7·5–12·2) months for PBC ([HR 0·92 [95% CI 0·69–1·22]). For patients PS 0–1, median OS was 23.6 (95% CI 18·2–31.6) and 11·8 (8·9–20·5) months with 24-month OS rates of 50% [38–61] for NI and 29% for PBC (HR 0·8 [95% CI 0·56–1.15]), In PS2 patients, median OS was 2·9 (95% CI 1·4–4·8) months for NI and 5.9 (3.5–29.9) months for PBC (HR 1·22 [95% CI 0·78–1.91]. Grade ≥3 AEs were most frequently neutropenia (27%) for PBC and gastrointestinal (11%), cardiac (10%), and endocrine (5%) disorders for NI. No significant differences in EQ-5D scores were observed between groups. However, perception of general health improved in the NI group, with median scores increasing from 50 at baseline to 70 atweek 18, while remaining stable in the PBC group (60 to 65).
Conclusions
The trial is still negative regarding the entire population. NI suggest a clinical signal of efficacy in patients aged ≥70 with advanced NSCLC and PS 0–1, with QoL maintained over time. Dedicated trials for geriatric and poor PS NSCLC patients must be developed.
Clinical trial identification
NCT03351361.
Legal entity responsible for the study
Groupe Francais de Pneumo Cancérologie.
Funding
Bristol Myers Squibb.
Disclosure
H. Lena: Non-Financial Interests, Personal, Other, attending meeting: Roche, Sanofi, Amgen, Takeda, Pfizer; Financial Interests, Personal, Advisory Board: Roche, MSD, Takeda, Daiichi Sankyo, Amgen, Pfizer. L. Greillier: Financial Interests, Institutional, Funding: Bristol Myers Squibb, MSD, Takeda, Pfizer, Roche, Amgen, Sanofi, Janssen, Lilly, Novartis; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, MSD, Takeda, Pfizer, Roche, Amgen, Sanofi, Janssen, Lilly, Novartis. O. Bylicki: Financial Interests, Personal, Advisory Board: Roche, Takeda, AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD, Bristol Myers Squibb, Janssen. I. Monnet: Financial Interests, Personal, Invited Speaker: Regeneron; Financial Interests, Personal, Other, attending meeting: Pfizer; Financial Interests, Personal, Other, attending meeting: MSD. A. Vergnenegre: Financial Interests, Personal, Invited Speaker: Pierre Fabre, Amgen, MSD; Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Pierre Fabre. P. Demontrond: Financial Interests, Personal, Other, attending meeting: Takeda; Financial Interests, Personal, Other, attending meeting: accord healthcare. F. Guisier: Financial Interests, Personal, Advisory Board: Roche, Takeda, AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD, Bristol Myers Squibb, Janssen. R. Corre: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb. C. Chouaid: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Sanofi, Bristol Myers Squibb, MSD, Lilly, Novartis, Pfier, Takeda, Bayer; Financial Interests, Personal, Invited Speaker: Amgen. C. Ricordel: Financial Interests, Personal, Advisory Board: Roche, Takeda, MSD, Bristol Myers Squibb, Janssen, Sanofi. All other authors have declared no conflicts of interest.