Phase 1 ARROW clinical trial results showed that Chinese trial participants with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) demonstrated an objective response rate of 73.1% to treatment with pralsetinib (Gavreto®), according to CStone Pharmaceuticals.
Pralsetinib had a 9-month duration of response rate of 100%, and the drug was tolerated well among these individuals. The participants also had no detected new safety signals that would negatively impact the safety profile.
The principal investigator of the ARROW study and president of Tianjin Union Medical Center, Gao Ming, commented, “The incidence rate of thyroid cancer has increased over the past several decades. There are limited treatments options available for patients with RET-mutant MTC.”
Following the presentation of the data at the 90th Annual Meeting of the American Thyroid Association, he added, “Gavreto had robust and durable anti-tumor activity and [a] well-tolerated safety profile. These results may be a promising advancement for patients with RET-mutant advanced MTC.”
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Three participants achieved a complete response, and 16 participants achieved a partial response, with an overall disease control rate of 84.6%. Investigators observed responses to pralsetinib regardless of the participant’s RET mutation genotype. These responses included reduction of calcitonin and carcinoembryonic antigen levels.
CStone Pharmaceuticals along with partner Blueprint Medicines discovered, researched, developed, and manufactured pralsetinib, a selective RET inhibitor. The National Medical Products Administration of China accepted the application of this supplemental new drug in April of 2021 for the treatment of advanced or metastatic RET-mutant MTC or RET fusion-positive thyroid cancer. Pralsetinib is approved by the US Food and Drug Administration for the treatment of certain types of cancer, including advanced or metastatic RET-mutant MTC.
CStone presents ARROW study data for GAVRETO® (pralsetinib) in Chinese patients with RET-mutant medullary thyroid cancer (MTC) for the first time in a late breaking oral abstract session at the 90th Annual Meeting of the American Thyroid Association 2021. News Release. CStone Pharmaceuticals; October 2, 2021.