(Solid Tumors) Is Zanidatamab Effective?

• November 25, 2022
• 1 min read

On November 15, 2022, Dr. Funda Meric-Bernstam and colleagues from the University of Texas MD Anderson Cancer Center published results in The Lancet Oncology from the Phase 1 clinical trial (NCT02892123) evaluating the efficacy and safety of Zanidatamab in patients with HER2-expressing or overexpressing locally advanced or metastatic solid tumors.

This Phase 1 trial was a multi-center dose-escalation study administering Zanidatamab (5 mg/kg to 30 mg/kg, every 1–3 weeks) to patients with HER2-expressing or overexpressing locally advanced or metastatic solid tumors. Part 1 primary endpoint was maximum tolerated dose (MTD); Part 2 primary endpoint was safety.

Results:

Part 1 enrolled 46 patients. No MTD or dose-limiting toxicities were identified. The recommended Phase 2 dose was determined to be 20 mg/kg every 2 weeks. Part 2 enrolled 86 patients. Most common adverse events included diarrhea (43%, N=37/86) and infusion-related reactions (34%, N=29/86). Grade 3 adverse events occurred in 3% (N=4/132). Of the 83 patients evaluable for efficacy in Part 2, 31 had confirmed objective responses.

Conclusion: Based on the Phase 1 trial results, Dr. Meric-Bernstam and colleagues concluded that Zanidatamab may demonstrate efficacy in HER2-expressing or overexpressing locally advanced or metastatic solid tumors, including biliary tract cancer, colorectal cancer, and other tumor types.

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00621-0/fulltext

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