Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, according to top-line data.
Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%.
Que Oncology Inc.’s Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, or hot flashes, in women taking endocrine therapy for breast cancer, and phase II results showed associated improvement in quality of life, compared with placebo.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free survival vs. a placebo.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
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