The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer.
Phase I/II Clinical Study Results
The Phase I/II clinical study of IBI354 as a monotherapy for patients with advanced solid tumors, including breast cancer, ovarian cancer, colorectal cancer, and other cancers, demonstrated good overall safety. No dose-limiting toxicity (DLT) was observed during the dose escalation phase, and treatment-related adverse events (TRAE) were found to be controllable. Preliminary efficacy results showed an impressive overall objective response rate (ORR) of 40.2% in platinum-resistant ovarian cancer patients and an 81.6% disease control rate (DCR), indicating the potential effectiveness of IBI354 in this patient population.
Implications for Cancer Treatment
The breakthrough therapy designation for IBI354 underscores its potential as a significant treatment option for patients with platinum-resistant ovarian cancer, a group that often faces limited therapeutic options. The positive results from the clinical study highlight the drug’s safety and efficacy, offering hope for improved treatment outcomes in this challenging disease setting.-Fineline Info & Tech
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