Loxo Oncology unveiled updated data from its trial of a drug targeted to genetic markers rather than specific tumor types Saturday, showing an improvement over data from an abstract that sent its shares up last month.
The Stamford, Connecticut-based firm announced the presentation of interim data from its Phase I study of LOXO-292, a drug that targets alterations of a gene known as RET.
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The data showed 77 percent of 49 patients with RET fusions responding, including 74 percent confirmed responses, according to a press release Saturday. Meanwhile, 45 percent of 29 patients with RET mutation-positive medullary thyroid cancer (MTC) responded, though 33 percent of patients had a confirmed response. Patients with RET fusions included those with thyroid cancer, non-small cell lung cancer and pancreatic cancer.
In terms of depth of response, one MTC patient had a complete response – meaning total disappearance of the tumor – while another had an unconfirmed complete response. All the other responses were confirmed or unconfirmed partial remissions. With 90 percent of patients with RET fusions and 93 percent of those with RET mutations remaining on therapy, the company said the drug showed early evidence of durability at the time of data cutoff, which was April 2.
Last month, an abstract for the study data released prior to the conference showed a 22 of 32 evaluable patients responding, yielding a 69 percent overall response rate, though 11 of those responses at the time were unconfirmed. Nevertheless, by the time markets closed the day after the abstract dropped, Loxo’s shares had risen 20 percent.
Another company developing a RET inhibitor is Blueprint Medicines, whose drug, BLU-667, is also targeted toward patients with
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Loxo’s lead product is larotrectinib, or LOXO-101, which targets NTRK fusions and is being developed under a partnership with German drugmaker Bayer. The company said Tuesday that the Food and Drug Administration had accepted its application for the drug’s approval based on Phase II clinical trial data. Data presented at the ASCO meeting last year showed a confirmed 76 percent response rate in children and adults with NTRK fusions. If approved, larotrectinib would be the second drug to win a so-called “tissue-agnostic” label, after Merck’s immunotherapy drug Keytruda, which received FDA accelerated approval last year in tumors with microsatellite instability-high and mismatch repair deficiency.
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