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Ref Type | Journal Article | ||||||||||||
PMID | (31036542) | ||||||||||||
Authors | Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE | ||||||||||||
Title | Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. | ||||||||||||
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Abstract Text | In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer. Results from a prespecified interim analysis of a phase III trial assessing NP-S + GM-CSF are reported.This multicenter, randomized, double-blind phase III study enrolled females ≥18 years with T1-T3, HER2 low-expressing (IHC 1+/2+), node-positive breast cancer in the adjuvant setting. Patients received 1,000 μg NP-S + 250 μg GM-CSF or placebo + GM-CSF monthly for 6 months, then every 6 months through 36 months. The primary objective was disease-free survival (DFS). Protocol-specified imaging occurred annually. New abnormalities were categorized as recurrence events; biopsy confirmation was not mandated. The interim analysis was conducted as specified in the protocol after 73 DFS events.A total of 758 patients (mean age 51.8 years) were randomized. Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%). There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm (P = 0.069).NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination. |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Nelipepimut-S Plus GM-CSF | Nelipepimut-S Plus GM-CSF | 0 | 1 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Nelipepimut-S Plus GM-CSF | E75 Plus GM-CSF|nelipepimut-S plus sargramostim|NeuVax Plus GM-CSF | HER2 (ERBB2) Vaccine 13 | Nelipepimut-S Plus GM-CSF comprises a ERBB2 (HER2) targeted peptide vaccine (E75) combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), which potentially results in increased immune response against ERBB2 (HER2) expressing tumor cells (PMID: 31036542). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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