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e-Poster Display Session

67P - Survival of responders to nivolumab (NIVO) + ipilimumab (IPI) as first-line treatment for advanced NSCLC in CheckMate 227, part 1

Date

09 Dec 2020

Session

e-Poster Display Session

Topics

Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Julie Brahmer

Citation

Annals of Oncology (2020) 31 (suppl_7): S1441-S1451. 10.1016/annonc/annonc392

Authors

J. Brahmer1, T. Ciuleanu2, M. Schenker3, C. Audigier-Valette4, B. Zurawski5

Author affiliations

  • 1 Johns Hopkins Kimmel Cancer Center, Baltimore/US
  • 2 Institute of Oncology Prof. Dr. Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca/RO
  • 3 SF. Nectarie Oncology Center, Craiova/RO
  • 4 Hôpital Sainte-Musse, Toulon/FR
  • 5 Ambulatorium Chemioterapii, Bydgoszcz/PL
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Abstract 67P

Background

In CheckMate 227 Part 1, first-line (1L) NIVO + IPI improved overall survival (OS) versus chemotherapy (chemo) in patients (pts) with advanced NSCLC and tumor PD-L1 ≥ 1% (a primary endpoint) and < 1% (prespecified descriptive analysis). With 3 years’ minimum follow-up, NIVO + IPI continued to provide durable responses and long-term efficacy benefits vs chemo.

Methods

CheckMate 227 Part 1 (NCT02477826) enrolled pts who were chemo-naive with stage IV / recurrent NSCLC. Pts with PD-L1 ≥ 1% (n = 1189) were randomized 1:1:1 to NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W, NIVO 240 mg Q2W, or histology-based chemo; those with PD-L1 < 1% (n = 550) were randomized 1:1:1 to NIVO + IPI, NIVO 360 mg Q3W + chemo, or chemo. Responses were assessed by blinded independent central review (BICR) using RECIST v1.1. An exploratory analysis assessed OS by best response as responders (complete or partial response [CR/PR]), or non-responders (stable disease [SD] or progressive disease [PD]) for NIVO + IPI or chemo. The impact of depth of tumor burden reduction (30–< 50%, 50–< 80%, and ≥ 80% from baseline) on OS was also investigated.

Results

After a minimum follow-up of 37.7 months (database lock, 28 Feb 2020), response rates (PD-L1 ≥ 1% and < 1%) were 33.4% with NIVO + IPI vs 28.0% with chemo. As expected, greater depth of response was associated with longer OS in both arms. The proportion of responders achieving ≥ 80% tumor burden reduction was 4x greater with NIVO + IPI vs chemo (10.8% vs 2.7%). Numerically longer median OS and higher 3-year OS rates were observed with NIVO + IPI vs chemo across tumor burden reduction categories (Table). Baseline characteristics and safety in responders will be presented. Table: 67P

OS by responsea and tumor burden reduction (PD-L1 ≥ 1% and < 1%)
Response and tumor burden reduction NIVO + IPI n = 583b Chemo n = 583b
Responder and ≥ 80%, n (%) Median OS, mo (95% CI) 3 y OS, % 63 (10.8) NR 86 16 (2.7) 41.1 (18.8–NR) 62
Responder and 50–< 80%, n (%) Median OS, mo (95% CI) 3 y OS, % 85 (14.6) 48.8 (46.0–NR) 73 68 (11.7) 28.4 (19.6–34.4) 38
Responder and 30–< 50%, n (%) Median OS, mo (95% CI) 3 y OS, % 47 (8.1) 32.5 (23.0–NR) 46 79 (13.6) 21.1 (16.5–27.6) 30
SD, n (%) Median OS, mo (95% CI) 3 y OS, % 187 (32.1) 13.7 (12.2–16.7) 20 286 (49.1) 13.0 (11.0–15.1) 17
PD, n (%) Median OS, mo (95% CI) 3 y OS, % 135 (23.2) 8.5 (6.2–11.5) 10 74 (12.7) 5.0 (4.2–6.9) 8

aPer BICR; bNot evaluable: NIVO + IPI, n = 66; chemo, n = 60. NR, not reached.

Conclusions

In 1L advanced NSCLC, pts treated with NIVO + IPI had a higher chance of achieving deeper responses than those treated with chemo. Responders with greater tumor burden reduction had greater long-term OS benefit; this correlation was more pronounced with NIVO + IPI treatment than chemo.

Clinical trial identification

NCT02477826.

Editorial acknowledgement

Janaki Iyer, PhD, of Caudex, funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

J.R. Brahmer: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Bristol Myers Squibb; Advisory/Consultancy: Merck; Advisory/Consultancy, Other: Data & Safety Monitoring Board/Committee: GlaxoSmithKline; Advisory/Consultancy, Other: Data & Safety Monitoring Board/Committees: Sanofi; Advisory/Consultancy: Regeneron. T-E. Ciuleanu: Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis/GSK; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Servier. M. Schenker: Research grant/Funding (self), Fees for clinical trial activities : Amgen; Research grant/Funding (self), Fees for clinical trial activities : Astellas; Research grant/Funding (self), Fees for clinical trial activities : AstraZeneca; Research grant/Funding (self), Fees for clinical trial activities : Bayer; Research grant/Funding (self), Fees for clinical trial activities : Bristol Myers Squibb; Research grant/Funding (self), Fees for clinical trial activities : Eli Lilly; Research grant/Funding (self), Fees for clinical trial activities : Gilead; Research grant/Funding (self), Fees for clinical trial activities : GlaxoSmithKline; Research grant/Funding (self), Fees for clinical trial activities: Merck; Research grant/Funding (self), Fees for clinical trial activities : MSD; Research grant/Funding (self), Fees for clinical trial activities : Mylan; Research grant/Funding (self), Fees for clinical trial activities : Novartis; Research grant/Funding (self), Fees for clinical trial activities : Pfizer; Research grant/Funding (self), Fees for clinical trial activities : Pharma Mar; Research grant/Funding (self), Fees for clinical trial activities : Regeneron; Research grant/Funding (self), Fees for clinical trial activities : Roche; Research grant/Funding (self), Fees for clinical trial activities : Serono. C. Audigier-Valette: Advisory/Consultancy: AbbVie; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche. B. Zurawski: Research grant/Funding (self): Amgen; Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Bristol Myers Squibb; Research grant/Funding (self): GlaxoSmithKline; Research grant/Funding (self): Janssen-Cilag; Research grant/Funding (self): MSD; Research grant/Funding (self): Roche. H. Linardou: Advisory/Consultancy: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: MSD; Advisory/Consultancy: Merck; Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy: Pfizer. S-W. Kim: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Lilly; Advisory/Consultancy: Norvasc. G.A. Otterson: Advisory/Consultancy, Research grant/Funding (self): Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy: Guardant Health; Advisory/Consultancy: Gilead; Research grant/Funding (self): Genentech; Research grant/Funding (self): Merck; Research grant/Funding (self): Pfizer; Research grant/Funding (self): Astellas. F. Barlesi: Honoraria (self): AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Bristol Myers Squibb; Honoraria (self): Boehringer-Ingelheim; Honoraria (self): Eli Lilly Oncology; Honoraria (self): F. Hoffmann-La Roche Ltd; Honoraria (self): Novartis; Honoraria (self): Merck; Honoraria (self): MSD; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Takeda. K. Feeney: Speaker Bureau/Expert testimony, Research grant/Funding (self): Bristol Myers Squibb. N. Frickhofen: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Roche Pharma; Research grant/Funding (institution), Documentation fee Clinical Trials incl CM227: ClinicalTrials.gov; Full/Part-time employment: University Cancer Center at the University Medical Center in Mainz, Germany. A. Li: Full/Part-time employment: Bristol Myers Squibb. P. Sun: Full/Part-time employment: Bristol Myers Squibb. M. Hellmann: Advisory/Consultancy: Merck; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Nektar; Advisory/Consultancy: Syndax; Advisory/Consultancy: Mirati; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Shattuk Labs; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Immunai; Advisory/Consultancy: Blueprint Medicines; Advisory/Consultancy: Achilles; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Arcus; Licensing/Royalties, Patent - institution. Use of TMB to predict response to immunotherapy (PCT/US2015/062208).: PGDx. All other authors have declared no conflicts of interest.

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