China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced positive results from the Phase III ZGDD3 study for its Category 1 anti-cancer drug donafenib in locally advanced/metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC).
Study Details and Results
A total of 191 patients were enrolled in the ZGDD3 study, with 128 in the donafenib group and 63 in the placebo group. The prespecified subgroup analysis revealed that the median progression-free survival (mPFS) for patients without a history of tyrosine kinase inhibitor (TKI) therapy was 18.3 months in the donafenib group versus 7.4 months in the placebo group. For patients with a history of TKI therapy, the mPFS was 11.0 months and 3.7 months, respectively. The study met its primary and key secondary endpoints, with mPFS of 12.9 months in the donafenib group and 6.4 months in the placebo group. The objective response rates (ORRs) were 23.3% and 1.7%, respectively, showing statistically significant improvements. The safety profile of donafenib was favorable, with the most common treatment-related adverse events (TRAEs) being hypertension (13.3%) and palmoplantar erythrodysesthesia syndrome (12.5%).
Drug Background and Approvals
Donafenib, a small-molecule oral multi-kinase inhibitor, received market approval in China as a first-line treatment for advanced hepatocellular carcinoma (HCC) in June last year. It was included in the National Reimbursement Drug List (NRDL) and multiple treatment guidelines. In July, the drug gained a second approval to treat locally advanced/metastatic RAIR-DTC in China.-Fineline Info & Tech
