HUTCHMED reports 42.5% fanregratinib response rate

• HUTCHMED reported pivotal Phase II data for fanregratinib in advanced intrahepatic cholangiocarcinoma.
• The single-arm China trial showed an IRC-assessed objective response rate of 42.5%.
• HUTCHMED said the data supported a China NDA that has received priority review.

HUTCHMED (NASDAQ:HCM) reported pivotal Phase II data for fanregratinib in pretreated advanced intrahepatic cholangiocarcinoma, with an IRC-assessed objective response rate of 42.5%.

The single-arm trial was conducted across 53 sites in China and enrolled patients with FGFR2 fusions or rearrangements after at least one prior systemic therapy.

“The clinical reality for this patient population with advanced FGFR2-fusion/rearrangement ICC is highly challenging,” said HUTCHMED study lead investigator Professor Jianming Xu.

The trial also showed a disease control rate of 83.9%, median duration of response of 6.9 months, median progression-free survival of 6.9 months, and median overall survival of 16.6 months.

Following the announcement, HUTCHMED's share price was up at $10.27.

HUTCHMED said China’s National Medical Products Administration has accepted the fanregratinib New Drug Application and granted it priority review.

HUTCHMED said fanregratinib remains part of its oncology pipeline, with the company retaining worldwide rights to the FGFR 1, 2 and 3 inhibitor.