Aduro Biotech Announces Presentation of Results from First-in-Human Phase 1 Study of Anti-CD27 Agonist as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors at the Society for Immunotherapy of Cancer 34th Annual Meeting
November 08, 2019 at 16:05 PM EST
BERKELEY, Calif., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today announced that its license partner, Merck & Co., Inc. (known as MSD outside the United States and Canada), presented data from an ongoing Phase 1 clinical trial of MK-5890, an anti-CD27 agonist. MK-5890 is being evaluated as monotherapy and in combination with KEYTRUDA® (pembrolizumab), an approved anti-PD-1 antibody, in adults with advanced solid tumors. The findings were accepted as a late-breaking abstract and presented by Dr. Ronnie Shapira-Frommer as an oral presentation at the Society for Immunotherapy of Cancer 34th Annual Meeting (SITC 2019) in National Harbor, MD (Abstract #O83).
“We are pleased with the clinical progress Merck has made to date in the development of MK-5890, a candidate selected with the same proprietary B-select monoclonal antibody technology at Aduro that created BION-1301, an anti-APRIL antibody in development for IgA nephropathy,” said Andrea van Elsas, Ph.D., chief scientific officer of Aduro. “We are encouraged by the early antitumor activity observed in patients with advanced solid tumors in both the MK-5890 monotherapy and combination therapy arms. We look forward to Merck’s further exploration of MK-5890’s potential in expansion cohorts, including an arm of MK-5890 administered with pembrolizumab, pemetrexed and carboplatin in patients with non-squamous non-small cell lung cancer.”
Study Design and Findings for MK-5890 (Database cutoff date: May 30, 2019)
In this Phase 1, open-label, multi-arm, multicenter, dose-escalation clinical trial (see www.clinicaltrials.gov, identifier NCT03396445), MK-5890 was administered to patients with advanced solid tumors by intravenous (IV) infusion every three weeks. Dose escalations for MK-5890 were 2 – 700 mg and pembrolizumab was administered as an IV injection at a dose of 200 mg every three weeks. Patients receiving MK-5890 as monotherapy who progressed while on therapy were eligible for crossover to the MK-5890-pembrolizumab combination arm. Study objectives included evaluation of safety, tolerability, pharmacodynamics, pharmacokinetics and tumor responses evaluated using RECIST v1.1 criteria.
Interim data presented at SITC 2019 were based on findings from 25 patients enrolled in the MK-5890 monotherapy arm and 19 patients enrolled in the combination arm with pembrolizumab. Fourteen patients had crossed over from monotherapy to receive the combination regimen. In the monotherapy arm, one patient achieved a confirmed partial response with MK-5890. In the combination arm, one patient achieved a confirmed partial response with MK-5890 and pembrolizumab. In the crossover phase, two patients achieved confirmed complete responses and two patients achieved confirmed partial responses with MK-5890 and pembrolizumab. At the time of analysis, two of the confirmed partial responses that crossed over were ongoing and had lasted six months or longer.
In the initial phase, dose-limiting toxicities, all of which were associated with infusion-related adverse events, were reported in 12 percent (n=3/25) and 5.3 percent (n=1/19) of patients in monotherapy and combination arms, respectively. Maximum tolerated dose was defined as 200 mg every three weeks. Treatment with MK-5890, alone and in combination with pembrolizumab, demonstrated an acceptable safety profile. Grade 3 – 4 treatment-related adverse events (TRAEs) were reported in 24 percent (n=6/25) and 21.2 percent (n=4/19) of patients in monotherapy and combination arms, respectively. The most common TRAEs (occurring in ≥10% of patients) in both study arms included: fatigue, infusion-related reaction, nausea, pruritus, rash, myalgia and vomiting. In the combination arm, additional TRAEs occurring in ≥10% of patients included: chills, diarrhea, pyrexia, dry mouth, influenza-like illness and increased amylase.
About CD27 and MK-5890
In 2014, Merck, through certain affiliates, entered into a worldwide license agreement with Aduro for the development and commercialization of anti-CD27 agonists, including MK-5890, which was identified with Aduro’s proprietary B-select monoclonal antibody technology.
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