1455P - Nivolumab (nivo) resumption in patients with advanced or metastatic non-small cell lung cancer (aNSCLC): Survival outcomes based on France and Germany real-world data (RWD)

Background

Nivo as monotherapy for the treatment of aNSCLC after prior chemotherapy (chemo) was approved by EMA in 2015 and has been used in clinical practice since. In this study, we describe RW survival outcomes of patients with aNSCLC who resumed nivo after interrupting an initial nivo treatment received as 2+ line-of-therapy (LOT).

Methods

This study leverages RWD collected in 2 prospective, non-interventional studies: EVIDENS (NCT03382496; France) and ENLARGE (NCT02910999; Germany) on patients with aNSCLC treated with nivo. Data were pooled and two cohorts were defined: 1) nivo resumption cohort (patients who re-started nivo after an interruption of ≥6 weeks) and 2) chemo cohort (patients who received chemo or other systemic anti-cancer therapy after nivo). Demographics and clinical characteristics were described, and overall survival (OS) was estimated using Kaplan-Meier methods from the start of the “index treatment” (LOT following the initial nivo treatment).

Results

Among 2,266 patients (1,397 from France and 869 from Germany), 210 (9.3%) resumed nivo after an initial interruption of ≥6 weeks. 697 (30.8%) started a chemo treatment after nivo, among which 171 - from the ENLARGE study - had data required for this analysis and constituted the chemo cohort. Median age was 67 (range: 41-89) in the nivo resumption cohort and 64 (21-83) in the chemo cohort. In both cohorts, majority of patients were male and received their index treatment as third LOT. Median OS was 19.6 months (mo) [95% CI: 16.2-25.2] for the nivo resumption cohort and 9.1 mo [7.1-10.0] for the chemo cohort. Nivo-resuming patients who had received an initial nivo treatment of ≥3 mo had a median OS of 22.8 mo, compared to 10.7 mo in patients with <3 mo initial nivo treatment. In the chemo cohort, patients with a duration of initial nivo therapy of ≥3 mo had a median OS of 9.9 mo in subsequent treatment, compared with 7.1 mo in patients with <3 mo of initial nivo treatment.

Conclusions

OS data show that patients with aNSCLC who interrupted their initial nivo treatment may benefit from resuming nivo, primarily when initial exposure to nivo lasted for more than three months.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

M. Pérol: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, Janssen, GSK, Eisai, Ipsen; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Boehringer Ingelheim, Takeda, Illumina, Pfizer, Medscape; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Takeda, Boehringer Ingelheim; Financial Interests, Personal, Steering Committee Member: Roche; Financial Interests, Personal, Other, DMSB: Roche. M. Sebastian: Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen Oncology, Lilly, MSD, Novartis, Pfizer/EMD Serono, Roche/Genentech, Sanofi, Takeda; Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen Oncology, Lilly, MSD, Novartis, Pfizer, Roche/Genentech, Sanofi, Takeda; Financial Interests, Institutional, Research Funding: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer, Takeda. F. Barlesi: Financial Interests, Institutional, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi Aventis, Seattle Genetics, Takeda, AbbVie, Acea, Amgen, Eisai, Ignyta; Non-Financial Interests, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd., Innate Pharma, Mirati. C. Schumann: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal, Writing Engagement: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS, Roche; Financial Interests, Institutional, Invited Speaker: Lilly. D. Reynaud, D. Waldenberger, A. Lee, N. Varol, J.R. Penrod, F. Brellier: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.