Abstract 1317P
Background
The real-world LIST study aims to describe patient (pt) characteristics, effectiveness, safety and IO rechallenge outcomes of NIV treatment in French pts with aNSCLC.
Methods
LIST is an ongoing longitudinal, prospective, observational study in pts with aNSCLC receiving NIV after at least one chemotherapy (CT) alone or with IO. It includes pts who are IO-naïve (Cohort 1), IO-experienced and discontinued due to reasons other than IO-toxicity (Cohort 2) and IO-experienced and discontinued due to IO-toxicity (Cohort 3). The primary endpoint is the time to treatment discontinuation (TTD). Interim results with ≥6 months (mo) follow-up are reported.
Results
At data cut-off (Dec 2023), 522 pts were enrolled (279/ 197/ 46 pts in Cohorts 1/ 2/ 3; median age 70/ 66/ 66.5 years, 68.5%/ 62.9%/ 78.3% male, 89.6%/ 88.3%/ 95.7% past/current smokers, 60.6%/ 76.1%/ 73.9% non-squamous histology, 74.2%/ 75.6%/ 67.4% Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0–1 at NIV initiation). At 6 mo, respective event-free rates for TTD were 35.3%/ 24.5%/ 31.6%; the main reason for discontinuation was disease progression. Numerically higher event-free rates were observed in pts with ECOG PS 0–1, fewer prior systemic therapy lines, longer prior IO duration, prolonged benefit with prior IO or if only prior IO (±CT) was NIV (Table). All grade treatment-related adverse events (TRAEs) were reported in 36.6%/24.5%/35.4% and grade 3/4 TRAEs in 7.5%/3.0%/12.5% of pts in Cohorts 1/ 2/ 3 respectively. Table: 1317P
Event-free rate for TTD at 6 mo, overall and by subgroup
| Cohort 1 | Cohort 2 | Cohort 3 | ||||
| n | Rate, % | n | Rate, % | n | Rate, % | |
| Overall | 279 | 35.3 | 197 | 24.5 | 46 | 31.6 |
| Subgroups | ||||||
| ECOG PS at NIV initiation | ||||||
| 0–1 | 207 | 38.9 | 149 | 29.2 | 31 | 38.7 |
| ≥2 | 72 | 25.0 | 48 | 9.6 | 15 | 15.2 |
| Last IO duration, months | ||||||
| 12 | – | – | 68 | 33.1 | 12 | 45.8 |
| Only prior IO (± CT) is NIV | – | – | 49 | 35.2 | 13 | 42.3 |
| Prior systemic therapy lines | ||||||
| 1 | 219 | 38.1 | 9 | 55.6 | 10 | 40.0 |
| 2 | 40 | 21.3 | 67 | 27.9 | 20 | 32.7 |
| ≥3 | 8 | 28.6 | 120 | 20.3 | 16 | 25.0 |
| Reason for last IO discontinuation | ||||||
| Progression | – | – | 166 | 21.5 | – | – |
| Prolonged benefit | – | – | 15 | 59.3 | – | – |
| PD-L1 expression | ||||||
ConclusionsLIST interim results show similar outcomes in IO-naïve pts as Checkmate 017/057, and promising effectiveness and safety of IO rechallenge in IO-experienced pts, especially in specific subgroups. Moreover, IO rechallenge results in pts who discontinued their prior IO due to IO-toxicity seem to be consistent with the safety profile of NIV. Clinical trial identificationNCT04500535. Editorial acknowledgementWe thank Sarah Greig, PhD, CMPP of Springer Healthcare who wrote the first draft of the congress abstract under guidance from the authors. This medical writing assistance was funded by Bristol Myers Squibb. Legal entity responsible for the studyBristol Myers Squibb. FundingBristol Myers Squibb. DisclosureB. Godbert: Financial Interests, Institutional, Advisory Board: MSD, AstraZeneca, BMS, Sanofi, Janssen; Financial Interests, Institutional, Local PI: MSD, BMS, Roche; Financial Interests, Institutional, Coordinating PI: AstraZeneca; Non-Financial Interests, Institutional, Other, Congress invitation: Pfizer. E. Gobbini: Other, Personal, Advisory Board: Janssen; Non-Financial Interests, Institutional, Local PI: Janssen; Other, Personal, Non financial benefits: Takeda, Sanofi; Non-Financial Interests, Institutional, Funding: BMS, AstraZeneca; Non-Financial Interests, Personal, Other: AstraZeneca; Non-Financial Interests, Personal, Invited Speaker: Sanofi, BMS. C. Decroisette: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Advisory Board: BMS, MSD, Takeda, Sanofi, AstraZeneca, Pfizer, Amgen. H. Lena: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. D. Moro-Sibilot: Financial Interests, Personal, Advisory Board: BMS. 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: Non-Financial Interests, Personal, Non remunerated activity: Adene; Financial Interests, Personal and Institutional, Advisory Board: Amgen, BMS, Boehringer Ingelheim, MSD, Novartis, Pfizer, Sanofi, AstraZeneca; Financial Interests, Institutional, Research Funding: BD Bioscience, Volition; Financial Interests, Institutional, Advisory Board: Celgene, Chugai, Janssen, Lilly, Roche, Takeda; Financial Interests, Personal, Advisory Role: Health Event; Financial Interests, Personal, Advisory Board: Maat Pharma, Pierre Fabre. F. Brellier: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. Y. Khalife: Financial Interests, Personal, Full or part-time Employment: 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, 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; Other, Family member is an employee: AstraZeneca. All other authors have declared no conflicts of interest. 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