Daiichi Sankyo Co. Ltd.’s quizartinib met the primary endpoint of overall survival in the pivotal phase III Quantum-First study, which tested the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML).
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move izokibep into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile.
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
Shanghai Henlius Biotech Inc.’s anti-PD-1 monoclonal antibody serplulimab has generated positive data in a phase III trial as a first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC).
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
I-Mab Biopharma Co. Ltd. chief medical officer John Hayslip said the firm is “moving forward at our best speed” in tandem with partner Shanghai Junshi Biosciences Co. Ltd. to produce a diagnostic test that could be used in further clinical work with anti-CD73 antibody uliledlimab, for which results from an ongoing phase II trial were disclosed May 26.
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2.
A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants.
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