Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization, for Vitrakvi (larotrectinib) and BAY 2731954 (LOXO-195). Both compounds are being developed globally for the treatment of adult and pediatric patients with advanced solid tumors harboring NTRK gene fusions. The option was triggered by the acquisition of Loxo Oncology by Eli Lilly and Company, which became effective today. As a result of this exercise, the joint co-promotion agreement in the U.S. between Bayer and Loxo Oncology is being converted to full commercialization in the U.S. by Bayer.
"Bayer is dedicated to improving the lives of cancer patients, and precision oncology is a promising area that has the potential to redefine the way cancer patients are treated. Our collaboration with Loxo Oncology was an important milestone and with the opportunity to exercise our option on Vitrakvi and BAY 2731954, we are taking the next step in our efforts to advance the future of cancer care and strengthen our leadership in this field," said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "With the first-ever approved TRK inhibitor with activity against TRKA, TRKB and TRKC, Vitrakvi, and BAY 2731954 progressing through clinical development, we have two compounds in our precision oncology portfolio and we are committed to expanding this portfolio by bringing forward highly differentiated and promising additional projects."
In November 2017, Bayer and Loxo Oncology entered into a global collaboration for the joint development and commercialization of the TRK inhibitors Vitrakvi and BAY 2731954 (LOXO-195). Following the change of control, Bayer will be solely responsible for the global development and commercialization of both Vitrakvi and BAY 2731954. Bayer is already leading ex-U.S. regulatory activities, and worldwide commercial activities. When the new exclusive licensing arrangement takes effect, the co-promotion in the U.S. will be converted into an exclusive commercialization by Bayer and the sharing of commercial costs and profits on a 50/50 basis for the U.S. market will be replaced by royalties to be paid by Bayer. Bayer will continue to pay royalties on future net sales outside the U.S.
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In addition, in connection with Bayer's exercise of the option, certain licenses granted by Loxo Oncology to Bayer will become exclusive following anti-trust clearance in the U.S.
Vitrakvi is an oral TRK inhibitor for the treatment of adult and pediatric patients with solid tumors with an NTRK gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Research suggests that the NTRK genes can become abnormally fused to other genes, producing a TRK fusion protein that can act as an oncogenic driver, leading to cancer cell growth and survival.
BAY 2731954 is an oral investigational new drug in clinical development rationally designed for the treatment of patients with cancers that have acquired resistance to initial TRK therapy. In July 2017, a multi-center Phase I/II trial in patients with TRK fusion cancers who have progressed while receiving another TRK inhibitor or are intolerant to another TRK inhibitor was initiated.
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer, regardless of where it originates in the body. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including lung, thyroid, GI cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (mammary analogue secretory carcinoma) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma).