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Polaris lung cancer clinical trial phase III analysis reached the highest standard, and drug certification is imminent

Polaris Group (TW:6550) released its interim analysis report for the Phase III clinical trial of pleural mesothelioma (a type of lung cancer) in the United States on February 25 (U.S. time). Based on the current interim data, the estimated probability of overall trial success is projected to exceed 80% (between 80% and 100%). Experts explain this indicates that upon completing patient enrollment for the Phase III trial, there is over an 80% probability that the overall survival rate in the ADI PEG-20 treatment group will demonstrate statistically significant superiority over the control group. This would constitute strong evidence of ADI efficacy, a necessary condition for obtaining drug approval. This clinical trial is a multinational, multicenter Phase II/III combination study evaluating Polaris Pharmaceuticals’ investigational drug ADI-PEG 20 in combination with first-line therapy (Pemetrexed + Cisplatin) for the treatment of mesothelioma. Enrollment is taking place across 41 hospitals in five countries: the United States, the United Kingdom, Australia, Taiwan, and Italy. The Phase II trial enrolled 176 patients, with a total target enrollment of 386 patients for both phases. By the end of February, 232 patients had been enrolled, and an interim analysis was conducted by an independent expert panel on the 25th. Polaris stated that while patient enrollment slowed significantly over the past year due to the pandemic, the encouraging interim results have motivated the company to accelerate enrollment efforts as the pandemic eases. The company aims to expedite patient recruitment and secure regulatory approval as soon as possible.

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