Iruplinalkib Phase III INSPIRE Study Outcomes in Thoracic Oncology Journal

A groundbreaking clinical trial has brought a new hope to patients battling non-small cell lung cancer (NSCLC). Qilu Pharmaceutical's innovative drug, iruplinalkib, has been recognized for its potential to transform first-line treatment for locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive NSCLC. The findings of this Phase III INSPIRE study have been published in a reputable journal, highlighting the drug's significant clinical value.

Iruplinalkib, a novel ALK receptor tyrosine kinase inhibitor (TKI), has shown remarkable efficacy in targeting both the wild-type and mutant ALK fusion genes. The trial, which was conducted across 40 centers in China under the leadership of Prof. Shi Yuankai, revealed that iruplinalkib not only extended the progression-free survival (PFS) of patients but also exhibited superior intracranial anti-tumor activity.

This multicenter Phase III clinical trial was a randomized, open-label study that compared iruplinalkib with crizotinib in treating patients with ALK-positive NSCLC who had not been previously treated with an ALK inhibitor. The study enrolled 292 patients, including those with central nervous system (CNS) metastases, from September 2019 to December 2020.

The study's results, as published in the Journal of Thoracic Oncology and reviewed by an Independent Review Committee, indicated that iruplinalkib significantly outperformed crizotinib in terms of median PFS, showing a 66% reduction in the risk of disease progression or death. The median PFS for the iruplinalkib group was 27.7 months, compared to 14.6 months for the crizotinib group.

Further analysis showed that iruplinalkib led to a longer duration of tumor response and a higher intracranial objective response rate (ORR) in patients with CNS metastases. The intracranial ORR for the iruplinalkib group was 57.9%, significantly higher than the control group's 25.6%. Moreover, the intracranial complete response rate was notably higher in the iruplinalkib group.

In terms of safety, the frequency of severe adverse reactions was similar between the two groups, despite the iruplinalkib group receiving treatment for a longer period.

The success of the INSPIRE study has led to the approval of iruplinalkib by the China National Medical Products Administration for use as a single-agent therapy in treating ALK-positive NSCLC. The ongoing study will continue to provide valuable insights, with updated results expected to be shared at future academic events. This development marks a significant step forward in the fight against lung cancer, offering patients a more effective treatment option.