Abstract
BackgroundWe 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 methodsPatients 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.ResultsAs 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.ConclusionAvelumab showed durable responses, promising survival outcomes, and an acceptable safety profile in patients with previously treated metastatic melanoma.Trial registrationClinicalTrials.gov identifier: NCT01772004.
Highlights
Cutaneous melanoma is the 15th most prevalent cancer worldwide, with an estimated 232,000 diagnoses each year, and accounts for 1.6% of all cancers [1]
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
The median duration of response was not estimable
Summary
Cutaneous melanoma (the most common melanoma subtype) is the 15th most prevalent cancer worldwide, with an estimated 232,000 diagnoses each year, and accounts for 1.6% of all cancers [1]. Long-term survival rates for patients with metastatic disease are improving with the incorporation of novel treatment options [4, 5], such as BRAFand MEK-targeted therapies, intratumoral oncolytic herpes viral therapies, and immune checkpoint inhibitors (ICIs) targeting cytotoxic T-lymphocyte associated–protein 4 (CTLA-4) and programmed cell death-1 (PD-1) [6]. Cutaneous melanoma is typically characterized by extensive tumor infiltration by T cells, high mutational burden, and an immunosuppressive phenotype, thereby supporting a role for ICIs. In contrast, the rarer, non-cutaneous subtypes are distinct from cutaneous melanoma with respect to presentation, staging, response to treatment, and patterns of progression [7,8,9]. 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
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