Avelumab in patients with previously treated metastatic melanoma: Phase 1b results from the JAVELIN Solid Tumor trial

Ulrich Keilholz, Janice M. Mehnert, Sebastian Bauer, Hugues Bourgeois, Manish R. Patel, Donald Gravenor, John J. Nemunaitis, Matthew H. Taylor, Lucjan Wyrwicz, Keun Wook Lee, Vijay Kasturi, Kevin Chin, Anja Von Heydebreck, James L. Gulley

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    8 Scopus citations

    Abstract

    Background: We report phase 1b data from patients enrolled in the JAVELIN Solid Tumor clinical trial (NCT01772004) with unresectable stage IIIC or IV melanoma that had progressed after ≥1 line of therapy for metastatic disease. Patients and methods: Patients received avelumab (10 mg/kg) - a human anti-PD-L1 antibody. Assessments included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Results: As of December 31, 2016, 51 patients were treated and followed for a median of 24.2 months (range, 16.1-31.5). Most patients had cutaneous (n = 28 [54.9%]) or ocular (n = 16 [31.4%]) melanoma and had received a median of 2 prior lines of therapy (range, 0-4), including ipilimumab (n = 26 [51.0%]). The confirmed ORR was 21.6% (95% CI, 11.3-35.3; complete response, 7.8%; partial response, 13.7%). The median duration of response was not estimable (95% CI, 2.6 months-not estimable). Median PFS and OS were 3.1 months (95% CI, 1.4-6.3) and 17.2 months (95% CI, 6.6-not estimable), respectively. Subgroup analyses suggested meaningful clinical activity (ORR [95% CI]) in patients with non-ocular melanoma (31.4% [16.9-49.3]), PD-L1-positive tumors (42.1% [20.3-66.5]), or prior ipilimumab therapy (30.8% [14.3-51.8]). Thirty-nine patients (76.5%) had a treatment-related adverse event (TRAE), most commonly infusion-related reaction (29.4%), fatigue (17.6%), and chills (11.8%); 4 patients (7.8%) had a grade 3 TRAE. Five patients (9.8%) had an immune-related TRAE (all were grade 1/2). No grade 4 TRAEs or treatment-related deaths were reported. Conclusion: Avelumab showed durable responses, promising survival outcomes, and an acceptable safety profile in patients with previously treated metastatic melanoma. Trial registration: ClinicalTrials.gov identifier: NCT01772004.

    Original languageEnglish (US)
    Article number12
    JournalJournal for immunotherapy of cancer
    Volume7
    Issue number1
    DOIs
    StatePublished - Jan 16 2019

    Keywords

    • Avelumab
    • Cutaneous melanoma
    • Immune checkpoint inhibitor
    • Ocular melanoma
    • PD-L1

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Immunology
    • Molecular Medicine
    • Oncology
    • Pharmacology
    • Cancer Research

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  • Cite this

    Keilholz, U., Mehnert, J. M., Bauer, S., Bourgeois, H., Patel, M. R., Gravenor, D., Nemunaitis, J. J., Taylor, M. H., Wyrwicz, L., Lee, K. W., Kasturi, V., Chin, K., Von Heydebreck, A., & Gulley, J. L. (2019). Avelumab in patients with previously treated metastatic melanoma: Phase 1b results from the JAVELIN Solid Tumor trial. Journal for immunotherapy of cancer, 7(1), [12]. https://doi.org/10.1186/s40425-018-0459-y