China-based innovative drug company Chipscreen Biosciences (SHA: 688321) has announced the completion of the analysis of results from the Phase III clinical trial for its drug candidate chiauranib, used as a monotherapy for third-line and above small cell lung cancer (SCLC). The independent review committee (IRC) has assessed the trial’s outcomes, providing valuable insights into the drug’s efficacy and safety profile.
IRC Assessment and mPFS Results
The IRC evaluation revealed that in the overall population post extensive anti-tumor immune therapy, chiauranib demonstrated a significant extension in median progression-free survival (mPFS) compared to the placebo group, reducing the risk of disease progression by over 70% (HR=0.289, P<0.001). This indicates a substantial benefit in delaying disease progression for patients treated with chiauranib.
mOS Results and Post-Treatment Analysis
However, in terms of the other primary endpoint, median overall survival (mOS), there was no significant difference observed between the chiauranib group and the placebo group in the overall population (HR=1.174, P=0.410). After excluding the interference of subsequent anti-tumor drug treatments as per the predefined analysis requirements, a significant trend towards extended mOS was observed in the chiauranib group (HR=0.394, P<0.05).
Decision Not to Pursue Market Approval
Following pre-communication with the National Medical Products Administration (NMPA) Drug Evaluation Center regarding the marketing application for this indication of chiauranib, and considering the clinical trial results and current changes in clinical practice, Chipscreen Biosciences has decided not to submit a marketing application for this indication.
Financial Impact of Asset Impairment
In light of this decision, Chipscreen Biosciences will fully provide for asset impairment on the development expenses related to the Phase III clinical trial of chiauranib monotherapy for third-line and above SCLC, which will correspondingly reduce the company’s profit total for the year 2024 by RMB 8847.59 million (unaudited).-Fineline Info & Tech
