1348P - Long-term survival and health-related quality of life with nivolumab for previously-treated advanced non-small cell lung cancer (NSCLC): A wide prospective French real-world study (EVIDENS)

Background

EVIDENS is a prospective, observational and multicenter study of NSCLC patients treated with nivolumab after prior chemotherapy. Prior report showed consistent outcomes as compared with randomized clinical trials¹. We report here long-term overall survival (OS) and health-related quality of life (HRQoL).

Methods

OS and progression-free survival were estimated using the Kaplan-Meier method with their 95% confidence intervals (CIs) and longitudinal HRQoL was assessed using EQ-5D-3L questionnaire and its associated Visual Analogic Scale (VAS; range: 0 to 100).

Results

Among the 1421 enrolled patients with advanced NSCLC, the 24- and 36-month OS rates were 29.4 % (95% CI: 26.9; 32.0) and 18.5% (95% CI: 15.6-21.6), respectively. With a minimum follow-up of 29 months, 13.1 % (95% CI: 11.3; 15.1) and 7.6 % (95% CI: 5.6; 9.9) of patients were progression-free survivors. At 24 months, the EQ-5D-3L and VAS were completed by 111 and 109 patients, respectively. The proportion of patients reporting no statistically change or improvement from baseline in the five dimensions of EQ-5D-3L was: self-care: 84.1%/4.7%; mobility: 72.0%/16.5%; anxiety-depression: 70.1%/15.9%; usual activities: 66.4%/14.0%; pain: 64.5%/19.6%. Mean VAS score at baseline was 71.7 [68.2; 75.2] and 74.5 [71.1; 77.8] at 24 months corresponding to a non-significant mean improvement from baseline of +2.76 [95%CI: -0.71; +6.23].

Conclusions

This analysis of advanced NSCLC patients treated in real life with nivolumab showed long-term survival outcomes consistent with the estimates from the randomized pivotal clinical trials². Furthermore, HRQoL of patients was stable at 24 months. ¹Barlesi F et al. OncoImmunology, 9:1,1744898, https://doi.org/10.1080/2162402X.2020.1744898 ²Vokes EE et al. Ann Oncol 2018; 29: 959–65.

Clinical trial identification

NCT03382496.

Editorial acknowledgement

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

F. Barlesi: Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: Bayer; Financial Interests, Personal, Other, outside the submitted work: Boehringer Ingelheim; Financial Interests, Personal, Other, outside the submitted work: Eli Lilly Oncology; Financial Interests, Personal, Other, outside the submitted work: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Pierre Fabre; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Takeda; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. A. Dixmier: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: Roche; Non-Financial Interests, Personal, Other, outside the submitted work: Novartis; Non-Financial Interests, Personal, Other, outside the submitted work: MSD; Non-Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Non-Financial Interests, Personal, Other, outside the submitted work: Boehringer Ingelheim; Non-Financial Interests, Personal, Other, outside the submitted work: Amgen; Non-Financial Interests, Personal, Other, outside the submitted work: Eli Lilly. D. Debieuvre: Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: Chugai Pharmaceuticals; Financial Interests, Personal, Other, outside the submitted work: Eli Lilly; Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: Janssen; Financial Interests, Personal, Other, outside the submitted work: GlaxoSmithKline; Financial Interests, Personal, Other, outside the submitted work: Pierre Fabre; Financial Interests, Personal, Other, outside the submitted work: Mundipharma; Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. C. Raspaud: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. J.B. Auliac: Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board, outside the submitted work: Roche; Financial Interests, Personal, Advisory Board, outside the submitted work: AstraZeneca; Financial Interests, Personal, Advisory Board, outside the submitted work: Boehringer Ingelheim; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Amgen; Financial Interests, Personal, Other, outside the submitted work: Pfizer. B. Nicolas: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. P. Bombaron: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. D. Moro-Sibilot: Non-Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Eli Lilly; Financial Interests, Personal, Other, outside the submitted work: AbbVie; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: Boehringer Ingelheim France; Financial Interests, Personal, Other, outside the submitted work: Takeda; Financial Interests, Personal, Other, outside the submitted work: Roche; Financial Interests, Personal, Other, outside the submitted work: Pfizer. C. Audigier-Valette: Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Boehringer Ingelheim; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Novartis; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Roche; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: MSD; Non-Financial Interests, Personal, Advisory Role, outside the submitted work: AstraZeneca; Financial Interests, Personal, Advisory Role, outside the submitted work: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role, outside the submitted work: Lilly; Financial Interests, Personal, Advisory Role, outside the submitted work: Novartis; Financial Interests, Personal, Advisory Role, outside the submitted work: MSD; Financial Interests, Personal, Advisory Role, outside the submitted work: Pfizer; Financial Interests, Personal, Advisory Role, outside the submitted work: Roche; Financial Interests, Personal, Advisory Role, outside the submitted work: AbbVie; Financial Interests, Personal, Advisory Role, outside the submitted work: FoundationOne; Financial Interests, Personal, Advisory Role, outside the submitted work: Takeda; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Lilly; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Novartis; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Pfizer; Financial Interests, Personal, Speaker’s Bureau, outside the submitted work: Roche. B. Asselain: Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. J. Dumanoir: Other, Personal, Full or part-time Employment, BMS employee: Bristol Myers Squibb. F. Cotté: Other, Personal, Full or part-time Employment, BMS employee: Bristol Myers Squibb. V. Allan: Other, Personal, Ownership Interest, BMS employee: Bristol Myers Squibb. C. Calvet: Other, Personal, Full or part-time Employment, BMS employee: Bristol Myers Squibb. D. Reynaud: Other, Personal, Full or part-time Employment, BMS employee: Bristol Myers Squibb. M. Pérol: Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Roche; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Eli Lilly; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Pfizer; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: MSD; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Boehringer Ingelheim; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Novartis; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Pierre Fabre; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Takeda; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Clovis; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca.