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
| Factor | Model value vs reference value | Hazard/odds ratio (95% CI) | P value |
|---|---|---|---|
| PFS | |||
| Treatment | NIVO+IPI vs NIVO | 0.65 (0.50, 0.83) | 0.0006 |
| LDH | ≤ULN vs >ULN | 0.56 (0.41, 0.77) | 0.0003 |
| OS | |||
| Treatment | NIVO+IPI vs NIVO | 0.65 (0.47, 0.90) | 0.0354 |
| LDH | ≤ULN vs >ULN | 0.44 (0.29, 0.67) | <0.0001 |
| ECOG PS | 0–1 vs 2–5 | 0.48 (0.31, 0.75) | 0.0016 |
| Response | |||
| Treatment | NIVO+IPI vs NIVO | 2.13 (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.