On December 11, 2017 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) ("Reata" or "the Company"), a clinical-stage biopharmaceutical company, reported the presentation of interim data from the ongoing Phase 1b portion of the REVEAL study of omaveloxolone in combination with approved checkpoint inhibitor (CI) therapies, ipilimumab or nivolumab, for the treatment of Stage III or IV unresectable or metastatic melanoma (Press release, Reata Pharmaceuticals, DEC 11, 2017, View Source;p=RssLanding&cat=news&id=2322028 [SID1234522532]). The data were presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno Oncology Congress 2017 in Geneva, Switzerland by lead author Dr. Sapna Patel, Assistant Professor, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center.
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All enrolled patients were required to have biopsy positive inducible nitric oxide synthase (iNOS), which is an independent predictor of poor survival in melanoma patients. Emerging translational data suggest that iNOS is a key mediator of myeloid-derived suppressor cells (MDSCs), whose presence has been shown to correlate with reduced activity of CIs. Of the 30 patients enrolled in REVEAL with evaluable tumor restaging, 7/30 (23%) of patients were checkpoint inhibitor-naïve, while 23/30 (77%) of patients were refractory to prior checkpoint inhibitor therapy. The overall response rate (confirmed + unconfirmed) observed in all evaluable patients was 8/30 (27%, 6 partial responses (PR) and 2 complete responses (CR)).
In CI-naïve patients, 4/7 (57%) had objective responses including 1 CR. 3/18 (17%) patients treated with omaveloxolone + nivolumab who were refractory to prior checkpoint inhibitor therapies had objective responses, including 1 CR. The majority of responses have been durable and are ongoing. Omaveloxolone treatment was associated with decreases in tumor iNOS, programmed death ligand 1 (PD-L1), and indoleamine 2,3-dioxygenase (IDO-1) expression. No serious AEs considered related to omaveloxolone have been reported to date. Commonly reported treatment-related adverse events included fatigue, nausea, pruritus, transaminase increases, and decreased appetite.
"The ongoing REVEAL trial data suggests that omaveloxolone may have activity in patients who are refractory to checkpoint inhibitors, which is an emerging and large unmet need," said Colin Meyer, M.D., Chief Medical Officer of Reata. "We are continuing with the dose escalation phase of the study to identify the optimal dose, and upon completion, we will determine the next steps in the clinical development program for omaveloxolone in melanoma."