1325P - Long-term survival and health-related quality of life in patients treated with nivolumab for advanced non-small cell lung cancer: 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 a-long-term survival benefit consistent with the estimates from _randomized clinical trials². Furthermore, HRQoL of patients was stable at 24 months. References ¹Barlesi F et al. OncoImmunology:1,1744898,doi: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 France.

Funding

Bristol-Myers Squibb France.

Disclosure

F. Barlesi: Honoraria (self), Non-remunerated activity/ies, outside the submitted work.: Bristol-Myers Squibb; Honoraria (self), outside the submitted work. : AstraZeneca; Honoraria (self), outside the submitted work. : Bayer; Honoraria (self), outside the submitted work. : Boehringer Ingelheim; Honoraria (self), outside the submitted work. : Eli Lilly Oncology; Honoraria (self), outside the submitted work. : F. Hoffmann–La Roche Ltd,; Honoraria (self), outside the submitted work. : Novartis; Honoraria (self), outside the submitted work. : MSD; Honoraria (self), outside the submitted work. : Pierre Fabre; Honoraria (self), outside the submitted work. : Pfizer; Honoraria (self), outside the submitted work. : Takeda. C. Raspaud: Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : Bristol-Myers Squibb. J.B. Auliac: Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : Bristol-Myers Squibb; Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : AstraZeneca; Non-remunerated activity/ies, outside the submitted work. : Roche; Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : MSD; Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : Boehringer; Honoraria (self), outside the submitted work. : Amgen. N. Benoit, P. Bombaron: Honoraria (self), Non-remunerated activity/ies, outside the submitted work. : Bristol-Myers Squibb. D. Moro-Sibilot: Honoraria (self), outside the submitted work. : Bristol-Myers Squibb; Honoraria (self), outside the submitted work. : MSD; Honoraria (self), outside the submitted work. : Roche; Honoraria (self), outside the submitted work. : AstraZeneca; Honoraria (self), outside the submitted work. : Pfizer. C. Audigier-Valette: Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, outside the submitted work. : Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, outside the submitted work. : AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, outside the submitted work. : Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, outside the submitted work. : Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, outside the submitted work. : Roche; Advisory/Consultancy, Non-remunerated activity/ies, outside the submitted work. : MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, outside the submitted work. : Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, outside the submitted work. : Pfizer; Advisory/Consultancy, outside the submitted work. : AbbVie; Advisory/Consultancy, outside the submitted work. : FoundationOne; Advisory/Consultancy, outside the submitted work. : Takeda. B. Asselain: Honoraria (self), Advisory/Consultancy, outside the submitted work. : Bristol-Myers Squibb. J. Dumanoir: Full/Part-time employment: Bristol-Myers Squibb. F-E. Cotte, V. Allan, N. Ozan, C.Y. Calvet, D. Reynaud: Full/Part-time employment, BMS employee: Bristol-Myers Squibb. M. Pérol: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Non-remunerated activity/ies, outside the submitted work. : Takeda. All other authors have declared no conflicts of interest.