Idera Pharmaceuticals Present Positive Phase I Data for their Drug candidate IMO-2125
Idera Pharmaceuticals announced final results from the dose-selection phase of an ongoing Phase 1/2 trial investigating IMO-2125 in combination with ipilimumab (Yervoy). The combination dose-selection phase included 18 patients, all but one of whom had progressed on nivolumab or pembrolizumab. Patients were treated with up to 6 doses of intratumoral IMO-2125 at doses ranging from 4 to 32 mg, along with standard dosing of ipilimumab. No dose-limiting toxicities were seen and the maximum tolerated dose (MTD) was not reached. No previously unreported immune-related toxicities were observed. The 8 mg IMO-2125 dose was selected for further development in combination with ipilimumab based upon acceptable safety, clinical activity, and evidence of target engagement on serial biopsies of the injected tumor and a distant (non-injected) metastasis.
DelMar Pharmaceuticals Initiates Phase 2 Trial for VAL-083 in GlioblastomaMultiforme
DelMar Pharmaceuticals announced the initiation of Phase 2 clinical trial for its lead agent VAL-083 in newly diagnosed MGMT-unmethylatedglioblastomamultiforme (GBM). The biomarker-driven clinical trial will explore safety and efficacy of chemoradiation with VAL-083 as an alternative to standard-of-care temozolomide in patients with MGMT-unmethylated GBM. The trial, which is being funded under the terms of DelMar’s collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma), is being conducted at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China. The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population.
Novartis Phase III study demonstrates reduced risk of disease recurrence by 53%
Novartis has published positive Phase III results of an 870 patient study with stage III BRAF V600E/K mutation-positive melanoma. The trial saw reduced recurrence rate of 53% after treatment with the combination of Tafinlar(dabrafenib) + Mekinist (trametinib). The trial met its primary endpoint by observing a reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo. Adverse events (AEs) were consistent with other Tafinlar + Mekinist studies, and no new safety signals were reported.
Humira gets EC approval for anterior uveitis
The European Commission has approved AbbVie’s Humira for the treatment of chronic non-infectious anterior uveitis in children aged two years or older who have had an inadequate response to or are intolerant to conventional therapy. Humira is now the only approved biologic treatment option for chronic non-infectious anterior uveitis in children aged two years and older in the European Union. Uveitis is an inflammation of the iris, choroid and the ciliary body in the eye. If left untreated, the disease can cause severe vision loss.