The biotech company announced data from its Phase I/II study of pralsetinib in RET fusion-positive non-small cell lung cancer and kicked off a rolling submission for FDA approval. Eli Lilly Oncology announced data for its own RET inhibitor in September.
The trial is the second Phase III study of the RET inhibitor selpercatinib, which Lilly acquired when it bought Loxo Oncology at the beginning of this year for $8 billion.
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Data showed LOXO-305 was broadly effective in patients resistant to BTK inhibitors regardless of whether they harbored a putative mechanism of resistance to the widely used blood cancer drugs.
Lilly, which acquired Loxo in January for $8 billion, said the new organization, dubbed Loxo Oncology at Lilly, would have responsibility for discovery research across therapeutic modalities, clinical development and regulatory affairs.
Bayer said Monday that the European Medicines Agency had approved Vitrakvi for NTRK fusion-positive cancers. The drug won U.S. Food and Drug Administration accelerated approval in November.
Analysts nevertheless wrote that with each data update, Lilly's RET inhibitor LOXO-292 (selpercatinib) appears less differentiated on efficacy as well as tolerability from Blueprint Medicines' BLU-667 (pralsetinib).
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On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
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Among 29 patients, the drug - designed for patients who become resistant to TRK inhibitors like Vitrakvi - showed a 34 percent response rate, according to Phase I data.
The agency set an August PDUFA date for entrectinib, which it gave priority review. It did the same for another Roche drug, polatuzumab vedotin, for high-grade lymphoma.
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Loxo's shares were up 65 percent on the news. The company won FDA accelerated approval on Nov. 26 for its tissue-agnostic cancer drug, Vitrakvi.
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That the drug will only be given to patients shown through testing to harbor a genetic anomaly that increases the odds of a response makes its approval an important milestone in the evolution of value-based care.
An oncologist compared NTRK fusion patients to a needle in a haystack, but had some clues of how to find them. Still, drugs like Vitrakvi call for genomic sequencing of all cancer patients, he said.