Oral Abstract Presentation
Nivolumab (Anti-PD-1; BMS-936558, ONO-4538) in Combination With Platinum-Based Doublet Chemotherapy (PT-DC) in Advanced Non-Small Cell Lung Cancer (NSCLC): Metastatic Non-Small Cell Lung Cancer

https://doi.org/10.1016/j.ijrobp.2014.08.024Get rights and content

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Purpose/Objective(s)

Treatments that improve clinical outcomes and extend long-term overall survival (OS) beyond that of first-line PT-DC are needed for patients (pts) with NSCLC. We report updated follow-up results of a phase 1 multi-cohort study evaluating nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, in combination with PT-DC for first-line treatment of chemotherapy-naïve pts with advanced NSCLC.

Materials/Methods

Chemotherapy-naïve pts (N=56) with advanced NSCLC were assigned according to histology to 1 of 4 cohorts in a phase 1 dose de-escalation trial. Pts received nivolumab 10 mg/kg IV Q3W (N10) plus concurrent IV gemcitabine (gem) 1250 mg/m2 + cisplatin (cis) 75 mg/m2 (squamous [sq; n=12]) or pemetrexed (pem) 500 mg/m2 + cis 75 mg/m2 (non-sq; n=15), or N10 (n=15) or nivolumab 5 mg/kg IV Q3W (N5; n=14) plus IV paclitaxel (pac) 200 mg/m2 + carboplatin (carb) AUC6 (sq and non-sq). PT-DC was given for 4

Results

No dose-limiting toxicities were seen during the first 6 wks of treatment. After a median follow-up of 75 wks, grade 3-4 treatment-related (nivolumab or PT-DC) adverse events (AEs) were reported in 45% of pts (25%-73% across arms), most commonly pneumonitis (grade 4, n=1; grade 3, n=3), fatigue (grade 3, n=3) and acute renal failure (grade 3, n=3). Grade 3-4 select AEs occurred in ≤7% of pts. Overall, 11 pts (20%) discontinued any study medication due to treatment-related AEs. ORR was 33% (N10

Conclusions

Nivolumab in combination with standard PT-DC regimens used for first-line treatment of NSCLC pts demonstrated acceptable ORR, PFS, and 1-year OS rates in chemotherapy-naïve pts, with a safety profile reflecting additive nivolumab and chemotherapy toxicities. Updated data on survival, response duration, and efficacy by tumor PD-1 ligand 1 (PD-L1) status will be presented.

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Author Disclosure: S.J. Antonia: E. Research Grant; Medimmune. F. Honoraria; Bristol-Myers Squibb. G. Consultant; Bristol-Myers Squibb. J.R. Brahmer: E. Research Grant; Bristol-Myers Squibb. G. Consultant; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. S. Gettinger: G. Consultant; Bristol-Myers Squibb. K. Advisory Board; Bristol-Myers Squibb. L.Q. Chow: E. Research Grant; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. R. Juergens: E. Research Grant; Bristol-Myers Squibb. F.A. Shepherd: F. Honoraria; Bristol-Myers Squibb. G. Consultant; Bristol-Myers Squibb. S.A. Laurie: None. D.E. Gerber: None. J. Goldman: E. Research Grant; Bristol-Myers Squibb, Genentech. Y. Shen: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. C. Harbison: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. A.C. Chen: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. H. Borghaei: E. Research Grant; Pfizer, Arisaph, Millenium. F. Honoraria; Genentech. G. Consultant; Genentech, Bristol-Myers Squibb. N.A. Rizvi: F. Honoraria; Bristol-Myers Squibb, Genentech/Roche, Medimmune. G. Consultant; Bristol-Myers Squibb.

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