Zymeworks(US:ZYME)2022-09-09 15:39Zanidatamab Clinical Development - Zanidatamab has Breakthrough Therapy designation by the FDA for previously-treated HER2 gene-amplified BTC[19] - HERIZON-GEA-01 study plans to enroll 714 patients across 30 countries[26] - In HER2+ First-Line GEA, Zanidatamab plus CAPOX showed a 93% confirmed objective response rate[32] - In HER2-Expressing Late-Line BTC, Zanidatamab monotherapy showed a 40% confirmed partial response rate and a 65% disease control rate[44] - In First-Line Breast Cancer, Zanidatamab in combination with Docetaxel showed a 90.5% confirmed objective response rate and a 95.2% disease control rate[49] ZW49 Clinical Development - Zanidatamab Zovodotin (ZW49) showed a 28% confirmed ORR and a 72% disease control rate in response-evaluable patients at 2.5 mg/kg Q3W[61] Partnerships and Financials - BeiGene has development and commercial rights to zanidatamab and ZW49 in Asia-Pacific (excluding Japan and India) with upfront payment of $40 million and up to $390 million in milestones[56] - BeiGene royalties are tiered up to 20% on sales in their territory[56] Strategic Priorities - Zymeworks aims to fully recruit HERIZON-BTC-01 and HERIZON-GEA-01 pivotal trials, targeting completion by YE 2023[69] - Zymeworks plans to advance two new product candidates to IND stage by YE 2024[69]