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Item 8.01 Other Events.
On January 19, 2023, Zymeworks Inc. (“Zymeworks”) and Jazz Pharmaceuticals plc (“Jazz”) released new data from an ongoing, open-label Phase 2 study (NCT03929666) evaluating zanidatamab in combination with chemotherapy as first-line treatment for patients with advanced HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA). The data were presented at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI).
The data demonstrated zanidatamab combined with standard chemotherapy is a highly active treatment regimen for first-line therapy for HER2-positive mGEA.
In 42 patients evaluable for overall survival (OS) receiving zanidatamab in combination with chemotherapy, the 18-month OS rate was 84% [95% CI: 68%, 93%], the 12-month OS rate was 88% [95% CI: 73%, 95%], and the median overall survival had not yet been reached (with 26.5 months median duration of study follow-up).
Treatment with zanidatamab resulted in a confirmed objective response rate (cORR) of 79% [95% CI: 63-90%], a disease control rate (DCR) of 92% (95% CI: 79-98%), with three patients achieving complete response among 38 response-evaluable patients.
The median duration of response was 20.4 months (95% CI: 8.3-NE) with a median progression-free survival (mPFS) of 12.5 months (95% CI: 7.1-NE) with 17 patients having an ongoing response at the time of data cutoff.
The regimen was manageable, tolerable, and consistent with the observed safety profiles for other standard combination regimens for patients with locally advanced or metastatic HER2-positive GEA.
A total of 46 patients with mGEA were enrolled from 15 sites across the United States, Canada and South Korea, and patients were administered zanidatamab with physician’s choice of chemotherapy treatment (standard first-line combination therapy).
Data were presented in a poster session entitled Zanidatamab + Chemotherapy as First-Line Treatment for HER2-expressing Metastatic Gastroesophageal Adenocarcinoma (mGEA) during the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) taking place in San Francisco.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Date: January 19, 2023||By:|
President and Chief Operating Officer