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A Melanoma Patient-Derived Xenograft Model
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Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial

Ulrich Keilholz1, Janice M Mehnert2, Sebastian Bauer3

  • 1Charité Comprehensive Cancer Center, Charitéplatz 1, 10117, Berlin, Germany. Ulrich.Keilholz@charite.de.

Journal for Immunotherapy of Cancer
|January 18, 2019
PubMed
Abstract

Insights

Avelumab demonstrated durable responses and promising survival in patients with metastatic melanoma. This immunotherapy showed an acceptable safety profile, with manageable side effects in the JAVELIN Solid Tumor trial.

Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Phase 1b data from the JAVELIN Solid Tumor trial (NCT01772004) are presented.
  • Focus on patients with unresectable stage IIIC or IV melanoma that progressed after at least one line of therapy for metastatic disease.

Purpose of the Study:

  • To evaluate the efficacy and safety of avelumab, a human anti-PD-L1 antibody, in patients with previously treated metastatic melanoma.
  • Assess objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety profile.

Main Methods:

  • 51 patients received avelumab (10 mg/kg).
  • Data collected included ORR, PFS, OS, and safety assessments.
  • Follow-up was conducted for a median of 24.2 months.

Main Results:

  • Confirmed ORR was 21.6% (95% CI, 11.3-35.3), with a complete response rate of 7.8%.
  • Median PFS was 3.1 months (95% CI, 1.4-6.3) and median OS was 17.2 months (95% CI, 6.6-not estimable).
  • Meaningful activity observed in subgroups: non-ocular melanoma (ORR 31.4%), PD-L1-positive tumors (ORR 42.1%), and post-ipilimumab therapy (ORR 30.8%).
  • 76.5% experienced treatment-related adverse events (TRAEs), most commonly infusion-related reactions and fatigue. Grade 3 TRAEs occurred in 7.8%, and immune-related TRAEs in 9.8% (all grade 1/2). No grade 4 TRAEs or treatment-related deaths.

Conclusions:

  • Avelumab demonstrates durable responses and promising survival outcomes in previously treated metastatic melanoma patients.
  • The safety profile of avelumab is acceptable, with a low incidence of severe adverse events.
  • Avelumab represents a viable treatment option for this patient population.
Keywords:
AvelumabCutaneous melanomaImmune checkpoint inhibitorOcular melanomaPD-L1

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