The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a reflection of the drug candidate’s previous breakthrough therapy designation (BTD) and its potential for conditional approval.
Zanidatamab’s Mechanism of Action and Clinical Performance
Zanidatamab is a bispecific antibody (BsAb) originally developed by Zymeworks (NASDAQ: ZYME), designed to bind in a trans fashion to two non-overlapping extracellular domains of HER2. This unique mechanism results in more potent effector function and multiple actions, including dual blockade of HER2 signaling, enhanced binding and removal of cell surface HER2 protein, and potent antibody effector function to enhance antitumor activity in patients. A Phase I clinical study demonstrated that zanidatamab produced a 47% objective response rate (ORR), 65% disease control rate, and a 6.6-month median response, with moderate adverse events, mostly level 1 or 2.
BeiGene’s Licensing Deal and Global Reach
In November 2018, BeiGene struck a USD 430 million licensing deal with Zymeworks, securing exclusive development and commercialization rights to the BsAbs ZW25 and ZW49 for the territories of Asia (excluding Japan), Australia, and New Zealand. This strategic move expanded BeiGene’s portfolio and global reach in the field of oncology.
Regulatory Recognition and Designations
In February of this year, zanidatamab was awarded breakthrough therapy designation (BTD) status in China for the treatment of HER2-positive locally advanced unresectable or metastatic biliary tract cancer (BTC) that has failed previous systemic chemotherapy. The drug has also received BTD status from the US FDA for BTC, orphan drug designations (ODDs) in biliary, gastric, and ovarian cancer, as well as fast-track status in refractory BTC and first-line gastroesophageal adenocarcinoma.-Fineline Info & Tech
