LBA59 - First-line nivolumab (NIVO) + ipilimumab (IPI) combined with 2 cycles of platinum-based chemotherapy (chemo) vs 4 cycles of chemo in advanced non-small cell lung cancer (NSCLC): Patient-reported outcomes (PROs) from CheckMate 9LA

Background

CheckMate 9LA (NCT03215706), a phase III randomized study, met its primary endpoint of improved overall survival with NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + 2 cycles of chemo (n = 361) vs 4 cycles of chemo (n = 358) in patients (pts) with treatment-naive, stage IV/recurrent NSCLC and no known sensitizing EGFR/ALK alterations. We present PROs from the study.

Methods

PROs were exploratory endpoints; disease-related symptoms were evaluated using the Lung Cancer Symptom Scale average symptom burden index and 3-item global index (LCSS ASBI/3-IGI); health-related quality of life (HRQoL) was evaluated using EQ-5D-3L visual analog scale and utility index (EQ-5D-3L VAS/UI). Analyses included mean changes from baseline, mixed-effect model repeated measures (MMRM) of longitudinal changes, and time to deterioration.

Results

PRO completion rates were > 80% across arms for most on-treatment assessment time points in which there were ≥ 10 pts (up to week 90 for NIVO + IPI + chemo and week 78 for chemo). A trend for improvement in LCSS ASBI and 3-IGI was seen in both treatment arms, though the minimally important difference was not reached. In both arms, mean EQ-5D-3L VAS scores approached UK population norms after ∼30 weeks. MMRM analyses showed similar improvement across arms in overall LCSS ASBI when there was a sufficient number of patients in both study arms for assessment (up to week 78). There was a decreased risk of, and delayed time to, definitive deterioration with NIVO + IPI + chemo vs chemo (Table).

Conclusions

Pts with advanced NSCLC treated with NIVO + IPI + chemo (2 cycles) maintained their quality of life as compared with chemo (4 cycles). Pts in the NIVO + IPI + chemo arm had decreased risk of definitive deterioration in HRQoL and symptoms vs chemo. Table: LBA59

Time to deterioration with NIVO + IPI + chemo (2 cycles) vs chemo (4 cycles)

Includes on-treatment and follow-up. ^aHR < 1 favors NIVO + IPI + chemo over chemo. ^bTime from randomization to when change in PRO score first meets/exceeds deterioration threshold. ^cIn addition to initial assessment, all subsequent assessments must meet/exceed the threshold. ^dBased on UK norms.

Clinical trial identification

NCT03215706.

Editorial acknowledgement

Professional writing assistance was provided by Laura Yee, of Caudex, funded by Bristol-Myers Squibb Company.

Legal entity responsible for the study

Bristol-Myers Squibb Company.

Funding

Bristol-Myers Squibb Company.

Disclosure

M. Reck: Advisory/Consultancy, Travel/Accommodation/Expenses: Abbvie; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Boehringer-Ingelheim; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: Merck; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Samsung. T-E. Ciuleanu: Advisory/Consultancy, Travel/Accommodation/Expenses: Astella Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Serono; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: AD Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis. M. Schenker: Research grant/Funding (self, related to the current clinical trial), Research grant/Funding (institution, related to the current clinical trial): Bristol Myers Squibb; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): MSD; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): AstraZeneca; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Pfizer; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Regeneron; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Novartis; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Roche; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Astellas; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): AbbVie; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Bayer; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Eli Lilly; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Merck Serono; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Gilead; Research grant/Funding (self, not related to the current clinical trial), Research grant/Funding (institution, not related to the current clinical trial): Amgen. B. Zurawski: Honoraria (self), Speaker Bureau/Expert testimony: Bayer; Honoraria (self), Speaker Bureau/Expert testimony: Astellas; Honoraria (self), Speaker Bureau/Expert testimony: MSD; Honoraria (self), Speaker Bureau/Expert testimony: Bristol Myers Squibb; Honoraria (self): Janssen Cilag; Honoraria (self): AstraZeneca. J. Bennouna: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Servier; Honoraria (self), Advisory/Consultancy: Bayer. L. Paz-Ares: Honoraria: Adacap; Honoraria: Amgen; Honoraria, Research grant/Funding: AstraZeneca; Honoraria: Bayer; Honoraria, Blueprint Medicines; Honoraria, Boehringer Ingelheim; Honoraria, Research grant/Funding: Bristol Myers Squibb; Honoraria: Celgene; Honoraria: Eli Lilly; Honoraria: Incyte; Honoraria: Ipsen; Honoraria, Research grant/Funding: Merck Sharp and Dohme; Honoraria: Novartis; Honoraria, Research grant/Funding: Pfizer; Honoraria: PharmaMar; Honoraria: Roche; Honoraria: Sanofi; Honoraria: Servier; Honoraria: Sysmex; Honoraria: Takeka; Leadership role: Altum sequencing; Officer/Board of Directors: Genómica. S. Lu: Advisory/Consultancy, Speaker bureau/Expert testimony, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Research grant/Funding (self): Bristol Myers Squibb; Research grant/Funding (self): Heng Rui; Advisory/Consultancy, Research grant/Funding (self): Hutchison Medipharma; Advisory/Consultancy: Simcere; Advisory/Consultancy: ZaiLab; Advisory/Consultancy: GenomiCare; Advisory/Consultancy, Speaker bureau/Expert testimony, Research grant/Funding (self): Roche; Speaker bureau/Expert testimony: Hansoh. T. John: Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Bayer; Advisory/Consultancy: Takeda; Honoraria (institution): Specialised Therapeutics; Honoraria (institution): Pfizer; Honoraria (institution): Novartis. B. Padilla, X. Sun, A. Moisei: Full-time employment: Adelphi Values. J. Yan, Y. Yuan: Full-time employment: Bristol Myers Squibb. S.I. Blum: Full-time employment, Stockholder: Bristol Myers Squibb. D.P. Carbone: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/ Expenses: AstraZeneca; Honoraria (self): Nexus Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Advisory/ Consultancy, Travel/Accommodation/Expenses: AbbVie; Leadership role: The Ohio State University; Leadership role: ASCO and AACR; Leadership role: NCI; Leadership role: Eastern Cooperative Oncology Group and the Thoracic Core committees for both the Alliance and ECOG/ACRIN; Leadership role, Past president: International Association for the Study of Lung Cancer (IASLC); Leadership role: Damon Runyon, K08, ASCO, AACR, CDA, LIFE and IDEA; Leadership role, Leader: Vanderbilt CCC’s Host-Tumor Interactions and Thoracic/Head and Neck Programs; Leadership role: Vanderbilt Lung Cancer SPORE, and an NCI U01 consortium; Officer/ Board of Directors: IASLC, LCFA, LUNGevity, ALCMI, Joan’s Legacy Foundation, Lance Armstrong Foundation, Wendy Wyrick Foundation, Wendy Will Case Foundation, Jack Roth Foundation; Full/ Part-time employment, Professor of Medicine: The Ohio State University Comprehensive Cancer Center; Advisory/Consultancy, Travel/Accommodation/Expenses: EMD Serono; Advisory/Consultancy, Travel/Accommodation/Expenses: Inviata; Advisory/Consultancy, Travel/Accommodation/Expenses: Inovio; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Loxo Oncology; Advisory/Consultancy, Travel/Accommodation/ Expenses: Merck, Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/ Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/ Genentech; Advisory/Consultancy, Travel/Accommodation/Expenses: Takeda Oncology; Advisory/ Consultancy, Travel/Accommodation/Expenses: Trinity; Advisory/Consultancy, Travel/Accommodation/ Expenses: Incyte; Advisory/Consultancy, Travel/Accommodation/Expenses: Kyowa Kirin; Advisory/ Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/ Accommodation/Expenses: Gritstone Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: GlaxoSmithKline; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche China; Advisory/Consultancy, Travel/Accommodation/Expenses: GenePlus; Advisory/Consultancy, Travel/ Accommodation/Expenses: Daiichi Sankyo Inc; Advisory/Consultancy: Seattle Genetics, GI Therapeutics (Intellisphere), Gloria Biosciences. All other authors have declared no conflicts of interest.