On February 7, 2018 Roivant Sciences and ArQule, Inc. (NASDAQ: ARQL) reported the initiation of a collaboration to pursue the development of derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor, in Greater China (Press release, ArQule, FEB 7, 2018, View Source [SID1234523772]). As part of the collaboration, ArQule has granted a Roivant subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, Macau, and Taiwan. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China.

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ArQule is currently conducting a registrational trial for derazantinib in the United States and Europe as a potential treatment for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer. The People’s Republic of China has one of the world’s highest incidences of iCCA, where it is the second most common form of liver cancer. Roivant intends to pursue the development of derazantinib in China for the treatment of iCCA while also pursuing further development in other tumor types with high rates of FGFR mutation.

"Intrahepatic cholangiocarcinoma is a devastating form of cancer, and there are no approved therapies globally," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "The prevalence of this disease is exceptionally high in China and we will do our part to further the development of derazantinib in that region."

"We are pleased with Roivant’s commitment to develop derazantinib in China, where the need for novel therapies is so pressing," said Paolo Pucci, CEO of ArQule. "We share their commitment to ensuring broad geographic access to new medicines, and we look forward to developing derazantinib in iCCA and other FGFR-driven cancers."

About Derazantinib

Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy. ArQule is currently conducting a registrational study with derazantinib in patients with FGFR2 fusion-positive second-line iCCA. The open-label single-arm trial is recruiting in both the United States and Europe with objective response rate as the primary endpoint. More information on that program is available here.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC).1 Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of 15% for patients diagnosed with early-stage disease.2 In China, the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and the majority of cases are intrahepatic.3