Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and Zymeworks Inc. (Nasdaq: ZYME) today announced that Jazz has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks' zanidatamab in key markets, including the U.S., Europe and Japan, pursuant to the license and collaboration agreement entered into in October 2022.
The decision to exercise this option follows positive top-line clinical data from HERIZON-BTC-01, a pivotal trial in previously treated HER2-amplified biliary tract cancers (BTC), which demonstrated that 41.3% (95% CI: 30.4, 52.8) of enrolled patients with HER2-amplified and expressing (IHC2+ and 3+) disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months (95% CI: 5.95 to not reached). The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified.
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