(Solid Tumors) Is Zanidatamab Effective?
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- 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
-
Clinical Trial Medications
- (Lung Cancer) Phase II results for Topotecan and Topotecan + Berzosertib combination.
- (Lung Cancer) Efficacy of Enhertu in HER2-mutant non-small cell lung cancer (NSCLC).
- (Lung Cancer) Clinical outcomes of anti-B7-H3 antibody-drug conjugate DS-7300.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free; an advisor will help you clarify the next steps.
Figure 1
Figure 2
Figure 3
Figure 4