Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion session - Melanoma and other skin tumours

4311 - Initial results from a phase 3b/4 study evaluating two dosing regimens of nivolumab (NIVO) in combination with ipilimumab (IPI) in patients with advanced melanoma (CheckMate 511)

Date

20 Oct 2018

Session

Poster Discussion session - Melanoma and other skin tumours

Presenters

Celeste Lebbé

Authors

C. Lebbé1, N. Meyer2, L. Mortier3, I. Marquez-Rodas4, C. Robert5, P. Rutkowski6, A.M. Menzies7, T. Eigentler8, P.A. Ascierto9, M. Smylie10, M. Ajaz11, I. Svane12, R. Gonzalez13, L. Rollin14, A. Saci15, E. Grigoryeva16, J. Pigozzo17

Author affiliations

  • 1 Ap-hp Dermatology Cic Departments, Hôpital Saint-Louis, 75010 - Paris/FR
  • 2 Dermatology Department, Université Paul Sabatier-Toulouse III, Institut Universitaire du Cancer and CHU de Toulouse, Toulouse/FR
  • 3 Dermatology Department, Université de Lille, Lille/FR
  • 4 Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid/ES
  • 5 Department Of Dermatology, Gustave Roussy, Villejuif/FR
  • 6 Department Of Soft Tissue/bone Sarcoma And Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw/PL
  • 7 Medical Oncology, Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney/AU
  • 8 Dermatooncology, University Hospital Tubingen, Tubingen/DE
  • 9 Unit Of Melanoma, Cancer Immunotherapy And Innovative Therapy, Istituto Nazionale Tumori Fondazione G. Pascale, Naples/IT
  • 10 Department Of Oncology, Cross Cancer Institute, Edmonton/CA
  • 11 Department Of Microbial And Cellular Sciences, Royal Surrey County Hospital, University of Surrey, Guildford/GB
  • 12 Department Of Oncology, Herlev Hospital, University of Copenhagen, Herlev/DK
  • 13 Division Of Medical Oncology, University of Colorado, Denver/US
  • 14 Global Biometric Sciences, Bristol-Myers Squibb, Princeton/US
  • 15 Clinical Biomarkers, Bristol-Myers Squibb, Princeton/US
  • 16 Global Clinical research, Bristol-Myers Squibb, Princeton/US
  • 17 Melanoma And Esophageal Cancer Unit, Veneto Institute of Oncology IOV – IRCCS, Padua/IT
More

Resources

Abstract 4311

Background

Combined inhibition of PD-1 and CTLA-4 with NIVO and IPI has demonstrated increased antitumor activity across several tumor types at various doses. In melanoma (MEL), NIVO 1 mg/kg plus IPI 3 mg/kg (NIVO1+IPI3) is the approved dose based on the CheckMate 067 trial, in which NIVO1+IPI3 and NIVO 3 mg/kg showed a higher objective response rate (ORR), longer progression-free survival (PFS), and improved overall survival (OS) vs IPI alone in patients (pts) with treatment-naive advanced MEL. CheckMate 511 was conducted to determine if NIVO 3 mg/kg plus IPI 1 mg/kg (NIVO3+IPI1) improves the safety profile of the combination.

Methods

Eligible pts were ≥18 years of age with unresectable stage III or IV MEL, an ECOG performance status of 0 or 1, no prior systemic therapy, and measurable disease by RECIST v1.1. Pts (N=360) were randomized 1:1 to NIVO3+IPI1 or NIVO1+IPI3 Q3W x 4; after combination therapy, pts in both groups received NIVO at 480 mg Q4W until progression or unacceptable toxicity. The primary objective was to compare the incidence of treatment-related grade 3-5 adverse events (AEs) between groups. Secondary objectives included descriptive analyses of efficacy endpoints, including ORR, PFS, and OS.

Results

At a minimum follow-up of ~12 months, the incidence of treatment-related grade 3-5 AEs among treated pts was significantly lower with NIVO3+IPI1 vs NIVO1+IPI3 (Table). One treatment-related grade 5 AE was reported in the NIVO3+IPI1 group and none in the NIVO1+IPI3 group. While ORR numerically favored NIVO1+IPI3, there were no significant differences in ORR, PFS or OS (Table).

NIVO3+IPI1
(N=180)

NIVO1+IPI3
(N=178)

Safety

Treatment-related grade 3-5 AEs, % (95% CI)

33.9 (27.0–41.3)

48.3 (40.8–55.9)

P value

0.0059

Efficacy

Investigator-assessed ORR, % (95% CI)

45.6 (38.1–53.1)

50.6 (43.0–58.1)

Difference in ORR, % (95% CI)

-4.9 (-15.2–5.3)

P value

0.3451

Median PFS, months (95% CI)

9.9 (6.0–20.0)

8.9 (6.0–NR)

Hazard ratio (95% CI)

1.06 (0.79–1.42)

12-month PFS rate, %

47.2

46.4

Median OS, months

NR

NR

Hazard ratio (95% CI)

1.09 (0.73–1.62)

12-month OS rate, %

79.7

81.0

Conclusions

CheckMate 511 met its primary endpoint, demonstrating a significantly lower incidence of treatment-related grade 3-5 AEs with NIVO3+IPI1 compared with NIVO1+IPI3 in MEL. Similar efficacy outcomes were observed between the two groups; however, longer follow-up may help to better evaluate outcomes.

Clinical trial identification

ClinicalTrials.gov, NCT02714218

Editorial Acknowledgement

Professional medical writing and editorial assistance were provided by Ward A. Pedersen, PhD, and Cara Hunsberger at StemScientific, an Ashfield Company, funded by Bristol-Myers Squibb.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.