Takeda highlights promising frontline results for ALK+ NSCLC drug Alunbrig; TGTX shares plunge on PhIII snafu
→ Takeda unveiled positive PFS data for its ALK+ NSCLC drug Alunbrig (brigatinib) today, underscoring a hazard ratio of 0.49 — a 51% drop in the risk of disease progression or death as a frontline therapy. “The ALK+ NSCLC treatment landscape has experienced tremendous change over the last decade, and the ALTA-1L trial demonstrates that brigatinib has the potential to be a key player in the first-line setting,” said Ross Camidge, the lead investigator of ALTA-1L.
→ Shares of TG Therapeutics $TGTX plunged more than 30% on Tuesday after the company tried — unsuccessfully — to explain a setback with its Phase III study of a combo of ublituximab plus umbralisib, or U2, to treat CLL. The biotech says that it can’t define the ORR right now because the data aren’t mature enough, leaving it to rely on the PFS for its marketing pitch. CEO Michael Weiss says he was disappointed he couldn’t report ORR today. So were investors.
→ San Diego-based Arena Therapeutics $ARNA is reporting positive data from its Phase IIa study of olorinab — an agonist of the cannabinoid receptor 2 for gastrointestinal pain. This is another example of the non-opioid drugs now in development.
→ As promised, Catabasis $CATB is pushing ahead into a Phase III study with its Duchenne MD drug edasalonexent, despite the fact that it failed their Phase II trial. Subsequent analyses allowed researchers to claim a victory, though that always raises doubts in R&D. Topline results are expected in Q2 2020.
→ Patrick Crutcher, a former associate of Martin Shkreli, has inked a deal to sell his company Ichorion to Cerecor $CERC for a batch of stock and $15 million in milestones. And he’s going back to BD after the buyout, according to a release Cerecor issued. The deal is valued at $26.6 million in company stock. Ichorion hasn’t had much presence in the industry. Its web face is little more than a home page with a way to send email to the company.
→ The FDA has scheduled an expert panel review for Sage’s brexanolone as a new treatment for postpartum depression for November 2.