The FDA delayed a decision for tislelizumab, until a site inspection of BeiGene’s Chinese manufacturing facility can be completed. Travel issues related to COVID-19 have prevented the FDA from inspecting the plant.
Announced Research Updates
Pluristem announced that in a 26-week, 240 patient, Phase III trial, treatment with PLX-PAD did not improve the Short Physical Performance Battery (SPPB) test score compared to placebo in patients undergoing hip arthroplasty following fracture.
Sesen Bio voluntarily paused development of oportuzumab monatox and is seeking financial partners to help fund further development.
Published Research Updates
In the 16-week, 666 patient, Phase III, POETYK PSO-1 trial, 58.4% of patients treated with deucravacitinib achieved PASI 75 and 53.6% achieved a Physician's Global Assessment (sPGA) score of 0 to 1 compared to 35.1% and 32.1% with apremilast and 12.7% and 7.2% with placebo in patients with moderate to severe psoriasis.
In the 112 patient cohorts of the Phase II, KRYSTAL-1 trial, treatment with adagrasib resulted in an ORR of 42.9% in patients with non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation, who had been treated with platinum-based chemotherapy and anti-programmed death 1 or programmed death ligand 1 therapy.
In a 100 patient, Phase 1b trial, treatment with zandelisib resulted in an objective responses of 92% with 60 mg and 120 mg, and 83% with 180 mg in patients with relapsed or refractory B-cell malignancy.
In the 20-week, 139 patient, Phase II ELEKTRA trial, treatment with soticlestat resulted in a 50% reduction in convulsive and drop seizure frequencies in Dravet syndrome patients compared to placebo. The decrease in seizures in Lennox-Gastaut syndrome patients was not significantly better than placebo.
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