Prelinimary results a Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate being developed by Zymeworks, will be presented during the annual meeting of the European Society for Medical Oncology, being held September 9 – 13, 2022 at the Paris Expo Porte de Versailles in Paris, France.

Zanidatamab zovodotin is a novel ADC comprised of a HER2-targeting bispecific antibody (directed against 2 non-overlapping HER2 epitopes) attached to a proprietary auristatin toxin with a protease-cleavable linker.

“Treatment of HER2-expressing solid cancers remains an area with significant unmet need, and these preliminary Phase 1 clinical results for zanidatamab zovodotin (ZW49) show that it offers a manageable safety profile and encouraging single-agent anti-tumor activity in patients with advanced disease that has progressed after treatment with standard of care therapies,” said Komal Jhaveri, MD, FACP, Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC.

“We look forward to continuing enrollment in the trial and to reporting on additional data as it becomes available in the months ahead,” Jhaveri noted.

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Adverse events
In an ongoing Phase 1 study of 76 patients with HER2+ cancers including gastric (28%) and breast (22%) cancers, preliminary results show that the majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and included keratitis (42%), alopecia (25%) and diarrhea (21%). Among seven patients who experienced TRAEs of grade 3 or higher, two were grade 4 events including infusion-related reaction and decreased neutrophil count.

There were three patient discontinuations associated with TRAEs and no reported treatment-related patient deaths or cases of interstitial lung disease. Results also showed encouraging single-agent anti-tumor activity in heavily pretreated patients with HER2+ cancers, including a confirmed objective response rate of 28% and a disease control rate of 72% in 29 patients treated at a dose of 2.5 mg/kg on an every three week (Q3W) schedule.

The preliminary data will be presented by Komal Jhaveri, MD, FACP, Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation on Monday, September 12 at 5:25 pm CEST.

Clinical trials
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers – NCT03821233

460MO – Preliminary results from a phase I study using the bispecific, human epidermal growth factor 2 (HER2)-targeting antibody-drug conjugate (ADC) zanidatamab zovodotin (ZW49) in solid cancers [Program]

General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 – October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.

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