Phase III
Agios Pharmaceuticals, headquartered in Cambridge, Mass., announced that its Tibsovo (ivosidenib) hit its primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 (IDH1) mutation.
The trial evaluated margetuximab in patients with HER2-positive metastastic breast cancer who had already been treated with anti-HER2-targeted therapies.
The 96-Week data showed continued efficacy of GS010 two years after injection, with best-corrected visual acuity (BCVA) holding a clinically meaningful improvement over baseline.
The FDA told the company that the results from the trial didn’t meet its primary endpoint under the pre-specified statistical analysis plan and the data around the secondary endpoints couldn’t be used to support an accelerated approval application.
The trial, B7451012, evaluated abrocitinib as a monotherapy for 12 weeks. The top-line data indicated that by week 12 the proportion of patients who hit each co-primary efficacy endpoint and each key secondary endpoint with either dose, 100 mg or 200 mg, were statistically significantly higher than placebo.
Data Safety Monitoring Board (DSMB) recommends the continuation of the RESOLVE-IT clinical trial without any modifications, based on the pre-planned review of safety data
Myovant Sciences announced positive data from LIBERTY 1, one of its two Phase III trials of once daily relugolix combination therapy in uterine fibroids. The trial met its primary endpoint and six key secondary endpoints.
The trial showed that the company’s auto-injector administered treatment delivered the same results as a previous trial using a pre-filled syringe.
Polarean Imaging plc announces an update regarding the Company’s Phase III Clinical Trials.
The company said that its lead product was creating greater-than anticipated kidney injuries in trial patients.
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