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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3613 - Assessment of real-world effectiveness of first-line (1L) nivolumab (NIVO) plus ipilimumab (IPI) or NIVO monotherapy for advanced melanoma: a retrospective cohort study

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Morganna Freeman

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

M. Freeman1, K. Gupte-Singh2, M. You3, T..K. Le3, C. Ritchings4, S. Rao2, S. Jang5

Author affiliations

  • 1 Department Of Medical Oncology & Therapeutics Research, City of Hope, 91010 - Duarte/US
  • 2 Health Economics Outcomes Research, Bristol-Myers Squibb, Princeton/US
  • 3 Center For Observational Research & Data Sciences, Bristol-Myers Squibb, Princeton/US
  • 4 Melanoma, Bristol-Myers Squibb, Princeton/US
  • 5 Hematology Oncology, Inova Melanoma and Skin Cancer Center, Fairfax/US
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Resources

Abstract 3613

Background

NIVO+IPI and NIVO are approved for 1L treatment of patients with unresectable or metastatic (advanced) melanoma. This study assessed real-world outcomes (objective response rate [ORR], progression-free survival [PFS], and overall survival [OS]) with NIVO+IPI or NIVO alone in patients with advanced melanoma using the US Flatiron Health electronic health record database from January 2011 to June 2017.

Methods

Eligible patients were aged ≥18 years, diagnosed with advanced melanoma, and treated with 1L NIVO+IPI or NIVO (index date). Outcomes were assessed based on an in-depth review of patient charts. Patients were followed until death, database discontinuation, or end of the study period. Factors associated with ORR, PFS, and OS were evaluated using logistic and Cox proportional hazards regression models. An evaluation of safety outcomes is ongoing.

Results

463 patients were eligible (NIVO+IPI, n = 254; NIVO, n = 209), with a mean follow-up of 9.2 months (range 1.0-31.6). Of those with data available, 39% of patients had elevated LDH, 35% had ECOG PS 1, and 33% were BRAF mutant. Compared with NIVO patients, NIVO+IPI patients were younger (71 vs 61 years) and a higher proportion were treated in academic centers (7.7% vs 18.9%). For NIVO+IPI and NIVO, ORR was 51% and 41%, median PFS was 12.2 and 5.4 months (1-year PFS rate 51% and 37%), and median OS was not reached and 20.1 months (1-year OS rate 71% and 60%), respectively. After adjusting for patient characteristics, NIVO+IPI patients were twice as likely to respond within 3 months, had a 35% lower likelihood of progression, and had a 35% lower likelihood of death compared with NIVO (Table).Table: 1281P

FactorModel value vs reference valueHazard/odds ratio (95% CI)P value
PFS
TreatmentNIVO+IPI vs NIVO0.65 (0.50, 0.83)0.0006
LDH≤ULN vs >ULN0.56 (0.41, 0.77)0.0003
OS
TreatmentNIVO+IPI vs NIVO0.65 (0.47, 0.90)0.0354
LDH≤ULN vs >ULN0.44 (0.29, 0.67)<0.0001
ECOG PS0–1 vs 2–50.48 (0.31, 0.75)0.0016
Response
TreatmentNIVO+IPI vs NIVO2.13 (1.27, 3.56)0.0039

Conclusions

In this real-world clinical practice database, 1L NIVO+IPI was associated with improved efficacy outcomes compared with NIVO alone in patients with advanced melanoma.

Clinical trial identification

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Editorial Acknowledgement

Editorial assistance was provided by StemScientific, funded by Bristol-Myers Squibb.

Disclosure

M. Freeman: Consulting role: Merck, Merck Serono, Novartis, Amgen; Speakers' bureau: Bristol-Myers Squibb. K. Gupte-Singh, M. You, T.K. Le, C. Ritchings, S. Rao: Employee: Bristol-Myers Squibb. S. Jang: Personal fees: Bristol-Myers Squibb.

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