Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238

Author:

Weber Jeffrey1ORCID,Del Vecchio Michele2,Mandalá Mario3ORCID,Gogas Helen4ORCID,Arance Ana M.5,Dalle Stephane6,Cowey C. Lance7,Schenker Michael8ORCID,Grob Jean-Jacques9ORCID,Chiarion-Sileni Vanna10ORCID,Márquez-Rodas Iván11ORCID,Butler Marcus O.12ORCID,Di Giacomo Anna Maria13,de la Cruz-Merino Luis14ORCID,Arenberger Petr15ORCID,Atkinson Victoria16,Hill Andrew17,Fecher Leslie A.18ORCID,Millward Michael19ORCID,Khushalani Nikhil I.20ORCID,Queirolo Paola21,Long Georgina V.22ORCID,Lobo Maurice23ORCID,Askelson Margarita23,Ascierto Paolo A.24ORCID,Larkin James25ORCID

Affiliation:

1. Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY

2. Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

3. Papa Giovanni XIII Hospital, Bergamo, Italy

4. Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece

5. Department of Medical Oncology, Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain

6. Department of Dermatology, Hospices Civils de Lyon, Pierre Bénite, France

7. Department of Medical Oncology, Texas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX

8. Oncology Center Sf Nectarie, Craiova, Romania

9. Department of Dermatology, Aix-Marseille University, Hôpital de la Timone, Marseille, France

10. Melanoma Oncology Unit, Veneto Institute of Oncology, IOV—IRCCS, Padua, Italy

11. Department of Medical Oncology, General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain

12. Department of Medical Oncology and Hematology, Department of Medicine, Department of Immunology University of Toronto, Princess Margaret Cancer Centre, Toronto, ON, Canada

13. Center for Immuno-Oncology, University Hospital of Siena, Siena, University of Siena, Italy

14. Department of Clinical Oncology, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen Macarena/CSIC/Universidad de Sevilla, Hospital University Virgen Macarena, Seville, Spain

15. Department of Dermatology, Charles University Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic

16. Division of Cancer Services, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia

17. Department of Medical Oncology, Tasman Health Care, Southport, QLD, Australia

18. Division of Hematology-Oncology, Department of Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, MI

19. Department of Internal Medicine, University of Western Australia and Sir Charles Gairdner Hospital, Nedlands, WA, Australia

20. Department of Cutaneous Oncology, H Lee Moffitt Cancer Center, Tampa, FL

21. Medical Oncology of Melanoma, Sarcoma and Rare Tumors, IEO European Institute of Oncology IRCCS, Milan, Italy

22. Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, NSW, Australia

23. Oncology Clinical Development, Bristol Myers Squibb, Princeton, NJ

24. Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy

25. Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, United Kingdom

Abstract

PURPOSE In phase III CheckMate 238, adjuvant nivolumab significantly improved recurrence-free survival compared with ipilimumab in patients with resected stage IIIB-C/IV melanoma without a significant difference in overall survival (OS). Here, we investigate progression-free survival (PFS) and OS after postrecurrence systemic therapy. PATIENTS AND METHODS Patients 15 years or older with resected stage IIIB-C/IV melanoma were stratified by stage and tumor PD-L1 status and randomly assigned to receive nivolumab 3 mg/kg every 2 weeks, or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks for 1 year or until disease recurrence, unacceptable toxicity, or withdrawal of consent. Patients with recurrence in each group were assessed for PFS and OS from subsequent systemic therapy (SST) initiation per recurrence timing (≤12 months [early] v >12 months [late] from initial therapy). RESULTS Recurrences occurred in 198 (44%) of 453 nivolumab-treated patients (122 early, 76 late) and 232 (51%) of 453 ipilimumab-treated patients (160 early, 72 late). Median PFS on next-line systemic therapy for nivolumab-treated patients recurring early versus late was 4.7 versus 12.4 months (24-month rates, 16% v 31%); median OS was 19.8 versus 42.8 months (24-month rates: 37% v 73%). In response to subsequent therapy, patients on nivolumab with late versus early recurrence were more likely to benefit from anti–PD-1 monotherapy. Nivolumab-treated patients with either an early or late recurrence benefitted from an ipilimumab-based therapy or targeted therapy, each with similar OS. CONCLUSION Postrecurrence survival was longer for patients who recurred >12 months. Patients on nivolumab who recurred early benefitted from SST but had better survival with ipilimumab-based regimens or targeted therapy compared with anti–PD-1 monotherapy.

Publisher

American Society of Clinical Oncology (ASCO)

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