Eli Lilly and Loxo: A Robust Oncology Pipeline for Future Years
Eli Lilly’s acquisition of Loxo has added the FDA approved asset VITRAKVI and the early- and mid-stage oncology pipeline assets LOXO-305, LOXO-195, and LOXO-292.
Jan. 9 2019, Updated 7:31 a.m. ET
Robust oncology pipeline
Eli Lilly and Company’s (LLY) acquisition of Loxo Oncology has added the FDA approved asset VITRAKVI and the early- and mid-stage oncology pipeline assets LOXO-305, LOXO-195, and LOXO-292.
According to Eli Lilly’s press release, the deal is expected to strengthen Eli Lilly’s position in the precision medicine market by adding selective medicines that target genomically defined cancers.
LOXO-195
According to LLY’s presentation, Loxo Oncology and Bayer are currently codeveloping the Phase 1/2 asset and TRK (tyrosine kinase) inhibitor LOXO-195 for patients who have acquired a resistance and aren’t responding to other TRK inhibitors. The asset is currently being studied in a Phase 1/2 trial, which started in July 2017.
Additionally, according to Eli Lilly’s M&A (mergers and acquisitions) conference call, LOXO-195 was granted an orphan drug designation by the FDA in October 2018. The company is expected to announce data from its Phase 1 trial in the first half of 2019.
According to Eli Lilly’s investor presentation, a new drug application for LOXO-195 is expected to be submitted in 2021, while a regulatory decision is expected in 2022.
LOXO-292
According to Eli Lilly’s investor presentation, investigational asset and selective oral RET inhibitor LOXO-292 has been granted a breakthrough therapy designation by the FDA in three indications: RET fusion-positive non-small cell lung cancer, RET mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer.
According to Eli Lilly’s M&A conference call, data from the ongoing registrational Phase 2 trial for LOXO-292 is expected in the second half of 2019, while a regulatory filing in the United States is expected in late 2019. According to the call, a regulatory decision and a commercial launch of LOXO-292 are expected in 2020.
LOXO-305
According to Eli Lilly’s investor presentation, Loxo Oncology has started a Phase 1/2 trial to evaluate non-covalent Bruton’s tyrosine kinase inhibitor LOXO-305 in B-cell leukemia and lymphoma indications.