Abstract CT075: Overall survival (OS) results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naïve patients with advanced melanoma (CheckMate 067)
Bibliographic record
Abstract
Abstract Background: NIVO plus IPI improved progression-free survival (PFS) and objective response rate (ORR) vs IPI alone in the phase II CheckMate 069 and phase III CheckMate 067 trials of treatment-naive patients (pts) with advanced melanoma (MEL). Here, we report the first OS results from CheckMate 067. Methods: Treatment-naïve patients (N=945) were randomized 1:1:1 to NIVO 1 mg/kg + IPI 3 mg/kg Q3W for 4 doses followed by NIVO 3 mg/kg Q2W, NIVO 3 mg/kg Q2W + placebo, or IPI 3 mg/kg Q3W for 4 doses + placebo, until progression or unacceptable toxicity. Pts were stratified by PD-L1 status (<5% vs ≥5%), BRAF mutation status, and M-stage. Co-primary endpoints are PFS and OS in the NIVO-containing arms vs IPI. Results: At a minimum follow-up of 28 months, median OS has not been reached in the NIVO+IPI or NIVO groups, and was 20.0 months for IPI (hazard ratio [HR]: NIVO+IPI vs IPI, 0.55; P<0.0001; NIVO vs IPI, 0.63; P<0.0001). In descriptive analyses, the relative risk of death in the NIVO+IPI group was reduced by 12% compared with the NIVO group (HR=0.88); 2-year OS rates were 64%, 59% and 45% for NIVO+IPI, NIVO, and IPI, respectively. Consistent OS results favoring NIVO+IPI over NIVO were observed across subgroups (HR ~0.88, including M1c and LDH). In pts with tumor PD-L1 expression ≥5%, median OS appeared comparable between NIVO+IPI and NIVO. Median duration of response has not yet been reached with NIVO+IPI, and was 31.1 months for NIVO and 18.2 months for IPI. The safety profile remained similar to the initial report, with grade 3-4 treatment-related AEs in the NIVO+IPI, NIVO, and IPI groups of 58%, 21% and 28%, respectively.NR=not reached. Conclusions: Both NIVO+IPI and NIVO significantly improved OS vs IPI alone. In descriptive analyses, NIVO+IPI appeared to provide favorable survival outcomes over NIVO alone, including across clinically relevant subgroups. Median OS, mo (95% CI)NIVO+IPINIVOIPIITTNRNR (29.1-NR)20.0 (17.1-24.6)M1c30.5 (19.4-NR)23.4 (16.5-32.3)15.0 (11.5-17.7)LDH >ULN17.4 (10.7-NR)15.0 (11.7-23.4)10.9 (8.4-13.1)BRAF MutantNRNR (26.4-NR)24.6 (17.9-31.0)PD-L1 ≥5%NRNR28.9 (18.1-NR)PD-L1 <5%NR (31.8-NR)NR (23.1-NR)18.5 (13.7-22.5) Citation Format: James Larkin, Vanna Chiarion-Sileni, Rene Gonzalez, Piotr Rutkowski, Jean-Jacques Grob, C. Lance Cowey, Christopher D. Lao, Dirk Schadendorf, Pier Francesco Ferrucci, Michael Smylie, Reinhard Dummer, Andrew Hill, John Haanen, Michele Maio, Grant McArthur, Dana Walker, Linda Rollin, Christine Horak, F. Stephen Hodi, Jedd D. Wolchok. Overall survival (OS) results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naïve patients with advanced melanoma (CheckMate 067) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr CT075. doi:10.1158/1538-7445.AM2017-CT075
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".