![]() The sellside should take heart in today’s data, since it had previously not assigned any value to Loxo-305. The plan is to gun for late-stage approval first before challenging covalent BTKs broadly, and to this end a randomised programme going head to head against approved BTK inhibitors is to start next year. It has yet to be determined how much data Lilly needs to take Loxo-305 to regulators. He reckons Loxo-305's only real competitor is ARQ 531, which “has a very narrow therapeutic index and is not really a selective kinase inhibitor I feel confident about our standing relative to that drug”. “A key differentiating feature of Loxo-305, in addition to the fact it doesn’t bind covalently, is that the pharmacology of the drug is excellent there is very high oral exposure,” Jacob Van Naarden, chief operating officer at Lilly’s Loxo division, told Evaluate Vantage. This raises an obvious question: how do patients relapse if not via C481S? Lilly’s hypothesis is that this is due to pharmacology failure. There is no analysis for the C481S mutation here, as it is rare in lymphoma. Saturday’s lymphoma cohort showed a 52% ORR in all-comers and in the 52 post-BTK patients alike. The case for Loxo-305 is broader, however, encompassing mutants and wild-type subjects alike, as well as those who have relapsed for unknown reasons.īacking this are the Ash data: the response rate was 63% in the 139 evaluable CLL patients, 62% in the subset of those who had failed a BTK inhibitor, and 71% in those who had failed specifically via the C481S mutation. This had been the pitch for ARQ 531, which yielded remissions in seven of eight C481S mutants before Merck pulled the acquisition trigger. It now includes 139 evaluable CLL patients, detailed today, while a 56-strong cohort in mantle cell lymphoma was presented on Saturday.Ī key reason for developing non-covalent BTK inhibitors is that patients given the covalent variety like Imbruvica can relapse via the C481S mutation. The Ash results are the first glimpse at Loxo-305’s Bruin trial since a year ago, when the dataset comprised just 13 chronic lymphoblastic leukaemia (CLL) and eight lymphoma subjects. ![]() As a non-covalent BTK inhibitor it now rivals Arqule’s ARQ 531, and investors will be well aware that based on a much smaller dataset Arqule was sold to Merck & Co for $2.7bn. Loxo-305 had been originated by Redx Pharma, but was sold off with no royalty obligation to Loxo for just $40m, before Loxo got bought by Lilly. However, through a bizarre set of circumstances the UK no longer has any stake in Loxo-305 – even though the project was invented in England. Success comes rarely to UK biotech, so when something as momentous as the data just reported at Ash with Loxo-305 happens it deserves to be celebrated.
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