63: Adjuvant therapy with nivolumab versus placebo in patients with resected stage IIB/C melanoma (CheckMate 76K)

Friday, March 24, 2023

11:24 AM – 11:34 AM

Location: Veterans Memorial Auditorium

Abstract Presenter(s)

Brian Gastman, MD

Surgical Director, Melanoma & High-Risk Skin Cancer Program
Cleveland Clinic Foundation, Cleveland, OH, USA, United States

Disclosure(s): No financial relationships to disclose

First Author(s)

Brian Gastman, MD

Surgical Director, Melanoma & High-Risk Skin Cancer Program
Cleveland Clinic Foundation, Cleveland, OH, USA, United States

Disclosure(s): No financial relationships to disclose

Author(s)

GL

Georgina V. Long, AO, BSc PhD MBBS FRACP FAHMS

Co-Medical Director
Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia, United States

Disclosure information not submitted.
JK

John M. Kirkwood, MD

Professor of Medicine, Dermatology and Co-Director, Melanoma and Skin Cancer P
UPMC Hillman Cancer Center, United States

Disclosure information not submitted.
CH

Christoph Hoeller, MD, PhD

Professor of Dermatology and Head of the Skin Cancer Center
Medizinische Universität Wien, United States

Disclosure information not submitted.
JW

Jeffrey Weber, MD, PhD

Deputy director of the Perlmutter Cancer Center
NYU Langone Medical Center, United States

Disclosure information not submitted.
JG

Jean-Jacques Grob, MD, PhD

Professor of Dermatology
Hôpital de la Timone, United States

Disclosure information not submitted.
PM

Peter Mohr, MD

Dermatology Specialist
Elbe Klinikum Buxtehude, United States

Disclosure information not submitted.
SG

Stephan Grabbe, MD

Managing Director of Dermatology
University of Mainz Medical Center, United States

Disclosure information not submitted.
CD

Caroline Dutriaux, MD

Melanoma Specialist
Hôpital Saint André, United States

Disclosure information not submitted.
VC

Vanna Chiarion-Sileni, MD

Head of Melanoma & Esophageal Oncology Unit
Veneto Institute of Oncology IOV-IRCCS, Veneto, Italy, United States

Disclosure information not submitted.
JM

Jacek Mackiewicz, PhD

Academician
Poznan University of Medical Sciences, Poznan, Poland, United States

Disclosure information not submitted.
PR

Piotr Rutkowski, MD, PhD

Professor of Surgical Oncology
Maria Skłodowska-Curie National Research Institute of Oncology, United States

Disclosure information not submitted.
PA

Petr Arenberger, DrSc., MBA

Professor and Chairman at the Department of Dermatovenereology
Charles University Third Faculty of Medicine and University Hospital of Královské Vinohrady, United States

Disclosure information not submitted.
GQ

Gaelle Quereux, MD

Dermatologist and Venerologist
Nantes University Hospital, United States

Disclosure information not submitted.
TM

Tarek Meniawy, MBBS FRACP PhD

Medical Oncologist
15Sir Charles Gairdner Hospital, United States

Disclosure information not submitted.
PA

Paolo A. Ascierto, MD

Director of the Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy
Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy, United States

Disclosure information not submitted.
Av

Alexander van Akkooi, MD, PhD

A/prof
Melanoma Institute Australia, Faculty of Medicine and Health, University of Sydney and Royal Prince Alfred Hospital, United States

Disclosure information not submitted.
PD

Piyush Durani, MD

Director, Global Oncology Clinical Development
Bristol Myers Squibb, United States

Disclosure information not submitted.
FC

Federico Campigotto, MS

Statistician
Bristol Myers Squibb, United States

Disclosure information not submitted.
MD

Michele Del Vecchio, MD, PhD

Head, Unit of Melanoma Medical Oncology
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, United States

Disclosure information not submitted.

Disclosure(s):

Brian Gastman, MD: No financial relationships to disclose

Introduction: Patients (pts) with resected stage IIB/C melanoma are at high risk of recurrence with outcomes similar to pts with resected stage IIIB disease. Adjuvant nivolumab (NIVO) has shown benefit in pts with resected stage III-IV melanoma. The phase 3 CheckMate 76K (CM76K; NCT04099251) trial assessed adjuvant NIVO v placebo (PBO) in pts with stage IIB/C melanoma after complete resection and negative sentinel lymph node biopsy. The current presentation adaptation will include primary data presented at SMR in October 2022, along with additional planned analyses.

Methods: Pts aged ≥12 y were stratified by T category and randomized 2:1 to receive IV NIVO 480 mg or PBO Q4W for 12 mo. The primary endpoint (EP) was recurrence-free survival (RFS); safety was a key secondary EP.

Results: Overall, 790 pts were randomized to NIVO (526) v PBO (264); 61% of all pts had stage IIB and 39%, stage IIC disease. Pts were followed for a minimum of 8 mo (median 15.8 mo NIVO; 15.9 mo PBO); 66/526 (13%) v 69/264 (26%) had a recurrence event. At this interim analysis, CM76K met the primary EP: NIVO significantly reduced the risk of recurrence v PBO (stratified HR 0.42; 95% CI 0.30–0.59; stratified P< 0.0001); 12-mo RFS rates for NIVO v PBO were 89% (95% CI 86–92) v 79% (74–84); substage rates were 93 v 84% (IIB) and 84 v 72% (IIC). RFS benefit was observed across predefined subgroups. For NIVO, 5% of all pts had distant recurrences and 2% regional; for PBO, it was 12% and 8%. In addition to RFS, NIVO reduced the risk of distant metastases or death v PBO (stratified HR 0.47 [95% CI, 0.30-0.72]). Grade 3-4 treatment-related adverse events (TRAEs) for NIVO v PBO were 10 v 2%; any-grade TRAEs leading to discontinuation were 15 v 3%. There was one TR death (0.2%) with NIVO (heart failure and acute kidney injury). In addition to the data here, additional RFS subgroup analyses are planned, as well as data on sites of distant metastases.

Conclusions: Adjuvant NIVO significantly improved RFS v PBO and decreased the risk of recurrence or death by 58% in pts with resected stage IIB/C melanoma, with efficacy benefit across subgroups. The safety results were similar to the known anti–PD-1 monotherapy profile with no new safety signals. NIVO is an effective adjuvant treatment option with a clinically meaningful benefit in resected stage IIB/C melanoma.

Learning Objectives:

Assess overall efficacy outcomes following treatment of nivolumab in patients with completely resected stage IIB/C melanoma
Assess safety of nivolumab treatment in patients with completely resected stage IIB/C melanoma
Assess efficacy of nivolumab treatment in subgroups of patients with completely resected stage IIB/C melanoma