Astrazeneca plc’s Tagrisso (osimertinib) seems poised to become standard of care in the adjuvant setting for early stage (IB, II and IIIA) EGFR-mutated non-small-cell lung cancer (NSCLC), thanks to phase III data from the study called Adaura, made public at the American Society of Clinical Oncology (ASCO) meeting.
The impact of COVID-19 is being felt at the American Society of Clinical Oncology (ASCO) annual meeting as much as anywhere else, typically held at McCormick Place in Chicago but this year conducted virtually because of the pandemic.
Arcus Biosciences Inc. “brings the milk without [Gilead Sciences Inc.] having to buy the whole cow” is the way one analyst characterized the pair’s 10-year cancer immunotherapy deal, which could be worth as much as $2 billion, and some may have detected downside for Arcus, as shares (NYSE:RCUS) closed May 27 at $27.05, down $6.49, or 19%. Foster City, Calif.-based Gilead is paying Arcus, of Hayward, Calif., $175 million up front, shelling out a $200 million equity investment, and pledging potentially $1.6 billion or more in the form of R&D support, opt-in cash and milestone payments.
Argenx SE’s later-stage effort with antibody fragment efgartigimod in generalized myasthenia gravis (gMG) was designed with guidance from the phase II trial that showed 75% of patients had a durable response of at least six weeks.
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection.
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it.
Due to launch in the second half of this year, Rallybio Inc.’s phase I/II study testing RLYB-211 for prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) will begin with experiments in men, said Steve Uden, one of the company’s three founders. “The good news is, we can confirm the safety and the pharmacology of this concept in male volunteers before having to start a clinical trial in pregnant mothers,” he told BioWorld.
Moderna Inc.’s chief medical officer, Tal Zaks, said that the results in hand “give us great confidence that we've got the right dose range for phase III” work slated to begin this summer with COVID-19 vaccine prospect mRNA-1273. A regulatory filing could come as early as 2021.
