NewLink Genetics Corporation Announces Interim Phase 2 Data Demonstrate Robust Response Rate with Indoximod
April 04, 2017 at 08:36 am EDT
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NewLink Genetics Corporation reported interim results from NLG2103, a Phase 2 study evaluating its IDO pathway inhibitor, indoximod, in combination with checkpoint inhibitors for the treatment of patients with advanced melanoma. These data report on a cohort of 60 evaluable patients (including patients with ocular melanoma) who received the combination of indoximod plus pembrolizumab which demonstrated a 52% (31/60) ORR and a 73% (44/60) DCR. Patients with non-ocular melanoma achieved a 59% (30/51) ORR and an 80% (41/51) DCR. The combination was generally well tolerated with low rates of Grade 3 or higher adverse events. These data will be presented in the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) 2017 Annual Meeting in Washington, D.C. NLG2103 is a Phase 2 study evaluating the addition of indoximod to the standard of care checkpoint inhibitors approved for patients with advanced melanoma (pembrolizumab, ipilimumab, or nivolumab). The interim data represent a cohort of 60 evaluable patients who received indoximod plus pembrolizumab. Evaluable patients were defined as those having at least one on-treatment imaging study. The primary outcome measure of the trial is objective response rate (ORR) and secondary outcome measures include disease control rate (DCR) and evaluation of safety and tolerability.
Lumos Pharma, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in advancing its clinical program and focused on identifying, acquiring, developing, and commercializing products and new therapies for people with rare diseases. Its pipeline is focused on the development of an orally administered small molecule, LUM-201, which is a growth hormone (GH) secretagogue, also called ibutamoren, for rare endocrine disorders that require injectable recombinant human growth hormone (rhGH). LUM-201 is a tablet formulation that is intended to be administered once daily. LUM-201 stimulates GH via the GH secretagogue receptor (GHSR1a), also known as the ghrelin receptor, and also suppresses the release of somatostatin, thus providing a differentiated mechanism of action to treat some rare endocrine disorders (involving a deficiency of GH) by increasing the amplitude of endogenous, pulsatile GH secretion. Lumos Pharma Sub, Inc. (Private Lumos) is its subsidiary.