Basilea teams up with Roche to test bladder cancer combination

Basilea Pharmaceutica has launched a collaboration with its fellow Basel, Switzerland-based biotech—Roche—to test a combination immunotherapy in advanced urothelial cancer.

Basilea’s derazantinib, an oral FGFR kinase family inhibitor, will be given alongside Roche’s PD-L1 checkpoint inhibitor Tecentriq in patients with confirmed FGFR genomic alterations. Basilea, which spun off from Roche in 2000, will serve as the sponsor of the multicohort phase 1/2 study that is planned to begin in the middle of this year with the Big Biotech providing a clinical supply of Tecentriq.

Derazantinib was licensed to Basilea from ArQule, in April 2018 for worldwide development and commercialization outside of China, Hong Kong, Macau and Taiwan. ArQule was paid $10 million upfront but is eligible for up to $326 million in milestone payments.

The drug targets FGFR kinases, which help drive cell proliferation, differentiation and migration, and have been identified as potential therapeutic objectives for cancers of the liver, bladder, breast, lung and gastric system. According to Basilea, FGFR alterations could exist in 5% to 30% of these cancers.

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Derazantinib also inhibits colony-stimulating factor 1 receptor kinase, which in turn helps lessen numbers of tumor-promoting macrophages and boost responses to T-cell checkpoint immunotherapies, such as PD-L1/PD-1 drugs like Tecentriq, the company said.

Earlier this month, Basilea unveiled interim data from a registrational trial of derazantinib, posting an objective response rate of 21% in 29 patients with intrahepatic cholangiocarcinoma, which forms within the bile ducts of the liver.

Six participants experienced partial responses that contributed to a disease control rate of 83%, which Basilea described as a promising interim analysis. Derazantinib has also received orphan designations in the U.S. and the EU for the indication.