70P - LIST (Lung Initiative on Sequence Therapy), a real-world study of nivolumab for advanced NSCLC in France: first effectiveness, safety, and IO-rechallenge results

Background

NSCLC treatment has evolved after approval of the 1st immunotherapy agent (IO) in 2015. The real-world LIST study of nivolumab for advanced NSCLC aims to describe patient/treatment characteristics, effectiveness, safety and rechallenge outcomes.

Methods

LIST is an ongoing longitudinal, prospective, observational study in patients (pts) with advanced NSCLC receiving nivolumab after one prior chemotherapy-based treatment alone or in combination with IO. Patient cohorts were: Cohort 1, IO-naïve patients; Cohort 2, IO-experienced patients who discontinued for non-IO-toxicity reasons; Cohort 3, IO-experienced patients who discontinued due to IO-toxicity. Descriptive interim analyses (follow-up ≥6 months) are presented.

Results

428 pts were enrolled between Sept 2020 and May 2022 at 99 centres – 278, 128 and 22 pts in cohorts 1, 2 and 3. Baseline patient characteristics were representative of advanced NSCLC: median age 65–70 years, male sex >65%, current/former smoker 22–27%/65–73%, non-squamous histology 60–75%. 41%/ 71%/ 76% of pts in cohorts 1/2/3 had PD-L1 expression (≥1%). At 6 months, respective overall survival (OS) rates were 70.0% [95% confidence interval 64.2–75.1%]/ 61.1% [51.6–69.3%]/ 61.2% [37.1–78.4%] and progression-free survival (PFS) were 33.4% [27.6–39.2%]/ 25.1% [17.2–33.8%]/ 51.0% [28.1–70.0%]. Current/former smokers and pts with tumour PD-L1 expression seem to have improved outcomes (table). All adverse events (AEs) occurred in 86%/ 78%/ 73% of pts and treatment-related grade 3/4 AEs in 11%/ 5%/ 18%, in cohorts 1/ 2/ 3. Table: 70P

Interim survival data by cohort and smoking and PD-L1 status

Conclusions

LIST interim results show nivolumab for IO-naïve pts in clinical practice has similar activity and safety as in the registrational CheckMate 017/057 trials. It shows encouraging results of rechallenge with nivolumab in pts with previous IO discontinuation, including for IO-toxicity.

Clinical trial identification

NCT04500535.

Editorial acknowledgement

We thank Sheridan Henness who provided medical writing assistance prior to submission on behalf of Springer Healthcare Communications.

Legal entity responsible for the study

The authors.

Funding

Bristol Myers Squibb.

Disclosure

B. Godbert: Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, AstraZeneca, Sanofi, MSD; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, AstraZeneca, MSD, Sanofi; Financial Interests, Personal, Expert Testimony: Bristol Myers Squibb, AstraZeneca, Sanofi, MSD. M. Zysman: Financial Interests, Institutional, Other: AVAD; Financial Interests, Personal, Speaker, Consultant, Advisor: CSL Behring, GSK, Boehringer Ingelheim, AstraZeneca, Chiesi, Sanofi; Financial Interests, Personal, Other: Chiesi, AstraZeneca, GSK. E. Gobbini: Financial Interests, Institutional, Other: BMS; Financial Interests, Personal, Other: AstraZeneca, Roche, Pfizer, Merck Sharpe and Dohm, Bristol Myers Squibb, Takeda, Janssen, Sanofi. C. Decroisette: Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, BMS, Takeda, Pfizer, Sanofi, Janssen, AstraZeneca, Amgen; Financial Interests, Personal, Other: Amgen, Janssen, Roche, MSD. H. Lena: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche AstraZeneca, MSD, Novartis, Takeda, BMS, Roche, MSD, Pfizer, Lilly, Amgen; Financial Interests, Personal, Other: BMS, Takeda, Pfizer. D. Moro-Sibilot: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Roche, AstraZeneca; Financial Interests, Personal, Other: Roche, MSD; Financial Interests, Personal, Advisory Board: BMS, Roche, MSD; Financial Interests, Institutional, Other: BMS, Roche, MSD. F. Guisier: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, MSD, Roche, Sanofi, Janssen, Pfizer, Takeda; Financial Interests, Institutional, Research Grant: Pfizer, Roche, Takeda. S. Couraud: Other, Personal, Advisory Board: Adene; Financial Interests, Personal and Institutional, Advisory Board, Institution Funding: Amgen, BMS, MSD, Novartis, Pfizer, Sanofi; Financial Interests, Personal and Institutional, Advisory Board, Institution Funding, Research Funding: AstraZeneca; Financial Interests, Institutional, Research Funding: BD, Transdiag, Volition; Financial Interests, Institutional, Funding: Celgene, Chugai, Janssen, Laidet, Lilly, Roche, Takeda; Financial Interests, Personal, Speaker, Consultant, Advisor: Health EvenT; Financial Interests, Personal, Advisory Board: MaaT Pharma. A. Caraux: Financial Interests, Personal, Affiliate: Bristol Myers Squibb. D. Reynaud: Financial Interests, Personal Boehringer Ingelheim, Affiliate: Bristol Myers Squibb. F. Breliier: Financial Interests, Personal, Affiliate: Bristol Myers Squibb; Financial Interests, Personal, Stocks or ownership: Bristol Myers Squibb. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer Ingelheim, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Personal, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Personal, Other, Family member is an employee: AstraZeneca. All other authors have declared no conflicts of interest.