Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172).

Abstract

BACKGROUND:

Nivolumab has been widely studied in non-acral cutaneous melanoma; however, limited data are available in other melanoma subtypes. We report outcomes by melanoma subtype in patients who received nivolumab after progression on prior ipilimumab.

PATIENTS AND METHODS:

CheckMate 172 was a phase II, single-arm, open-label, multicentre study that evaluated nivolumab in patients with advanced melanoma who progressed on or after ipilimumab. Patients received 3 mg/kg of nivolumab, every 2 weeks for up to 2 years. The primary end-point was incidence of grade ≥3, treatment-related select adverse events (AEs).

RESULTS:

Among 1008 treated patients, we report data on patients with non-acral cutaneous melanoma (n = 723 [71.7%]), ocular melanoma (n = 103 [10.2%]), mucosal melanoma (n = 63 [6.3%]), acral cutaneous melanoma (n = 55 [5.5%]) and other melanoma subtypes (n = 64 [6.3%]). There were no meaningful differences in the incidence of grade ≥3, treatment-related select AEs among melanoma subtypes or compared with the total population. No new safety signals emerged. At a minimum follow-up of 18 months, median overall survival was 25.3 months for non-acral cutaneous melanoma and 25.8 months for acral cutaneous melanoma, with 18-month overall survival rates of 57.5% and 59.0%, respectively. Median overall survival was 12.6 months for ocular melanoma and 11.5 months for mucosal melanoma, with 18-month overall survival rates of 34.8% and 31.5%, respectively.

CONCLUSIONS:

The safety profile of nivolumab after ipilimumab is similar across melanoma subtypes. Compared with non-acral cutaneous melanoma, patients with acral cutaneous melanoma had similar survival outcomes, whereas those with ocular and mucosal melanoma had lower median overall survival. CLINICALTRIALS.

GOV ID:

NCT02156804.

• Authors: Paul Nathan, Paolo A Ascierto, John Haanen, Enrique Espinosa, Lev Demidov, Claus Garbe, Michele Guida, Paul Lorigan, Vanna Chiarion-Sileni, Helen Gogas, Michele Maio, Maria Teresa Fierro, Christoph Hoeller, Patrick Terheyden, Ralf Gutzmer, Tormod K Guren, Dimitrios Bafaloukos, Piotr Rutkowski, Ruth Plummer, Ashita Waterston, Martin Kaatz, Mario Mandala, Ivan Marquez-Rodas, Eva Muñoz-Couselo, Reinhard Dummer, Elena Grigoryeva, Tina C Young, Dirk Schadendorf
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 119 Pg. 168-178 (09 2019) ISSN: 1879-0852 [Electronic] England
• PMID: 31445199 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright © 2019 Elsevier Ltd. All rights reserved.

Chemical References

• Ipilimumab
• Nivolumab

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Diarrhea (chemically induced)
• Disease Progression
• Drug Administration Schedule
• Female
• Humans
• Ipilimumab (administration & dosage, adverse effects)
• Kaplan-Meier Estimate
• Male
• Melanoma (drug therapy, pathology)
• Middle Aged
• Nivolumab (administration & dosage, adverse effects)
• Skin Diseases (chemically induced)
• Skin Neoplasms (drug therapy, pathology)
• Treatment Outcome
• Young Adult