Promising Phase II Trial Results for Iruplinalkib Tablets Unveiled
Phase II Clinical Trial Overview
During a recent global health conference, remarkable findings were shared regarding the Phase II clinical trial of iruplinalkib tablets, also recognized as Qixinke. This trial, referred to as the INTELLECT study, delved into the effects of the drug on patients battling anaplastic lymphoma kinase (ALK)-positive crizotinib-resistant non-small-cell lung cancer (NSCLC).
Understanding Iruplinalkib
Iruplinalkib, developed by Qilu Pharmaceutical, is an advanced ALK/ROS1 kinase inhibitor. It garnered approval in June 2023 from the NMPA for treating patients with ALK-positive locally advanced or metastatic NSCLC who demonstrated progress after crizotinib therapy or were unable to endure its side effects. Earlier this year, it also received approval for first-line treatment for ALK-positive NSCLC.
Study Leadership and Results
The study, spearheaded by Prof. Yuankai Shi from the Cancer Hospital of the Chinese Academy of Medical Sciences & Peking Union Medical College, has made significant strides. The preliminary data was initially published in BMC Medicine in 2023, presenting its findings after an extended two-year follow-up at the conference.
Trial Participants and Survival Rates
The INTELLECT study involved 146 participants, providing comprehensive insights into treatment efficacy. As of the last follow-up, participants had a median follow-up duration of 42.41 months, showcasing a median overall survival (OS) rate of 41.79 months. Furthermore, the trial reported an objective response rate (ORR) of 63.7% and an impressive disease control rate (DCR) of 94.5%. The study also highlighted median duration of response (DoR) and median progression-free survival (PFS) at 14.06 months and 14.55 months, respectively.
Impact on Patients with CNS Metastasis
A deeper analysis of 90 patients exhibiting CNS metastasis at the beginning of the study demonstrated an ORR of 55.6% and a DCR of 93.3%. Notably, median values for DoR and PFS were documented at 17.25 months, with median OS reaching 43.01 months.
Intracranial Responses and Safety Profile
The study applied RECIST v1.1 criteria, registering an 18.9% intracranial complete response (CR) among patients initially presenting with CNS metastasis. In the subgroup of 42 patients who had measurable intracranial lesions, an intracranial objective response rate (iORR) of 64.3% and an iDCR of 95.2% were reported.
On the safety front, the trial observed a high incidence of treatment-related adverse events (TRAEs) at 93.8%, with 30.8% of these classified as grade 3 or 4. Common TRAEs included elevations in aspartate aminotransferase, hypercholesterolemia, and increased alanine aminotransferase levels. Importantly, no new safety signals emerged during this study.
Long-term Benefits of Iruplinalkib
The long-term follow-up from the INTELLECT trial underlined that iruplinalkib offers significant OS benefits for patients with advanced NSCLC resistant to crizotinib while maintaining a robust safety profile.
Frequently Asked Questions
What is iruplinalkib?
Iruplinalkib is a next-generation ALK/ROS1 kinase inhibitor developed specifically for treating ALK-positive non-small-cell lung cancer.
What were the key findings from the Phase II clinical trial?
The trial reported a median overall survival of 41.79 months with high objective response and disease control rates, along with a manageable safety profile.
Who led the INTELLECT study?
The study was led by Prof. Yuankai Shi from the Cancer Hospital of the Chinese Academy of Medical Sciences & Peking Union Medical College.
Is iruplinalkib approved for use?
Yes, iruplinalkib has received approval from the NMPA for treating patients with advanced ALK-positive NSCLC.
What are treatment-related adverse events associated with iruplinalkib?
Common adverse events include elevated liver enzymes and hypercholesterolemia, but no new safety signals have been detected during the study.
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