China-based QiLu Pharmaceutical has announced positive data from a Phase III trial investigating iruplinalkib in patients with non-small cell lung cancer (NSCLC).

The data analysis showed that the primary endpoint of progression-free survival (PFS) met the pre-defined criteria. Additionally, PFS in the treatment group was significantly improved compared to the comparator cohort, with a median PFS of 27.7 months and 14.62 months, respectively.

Iruplinalkib also showed superior results compared to crizotinib, which was a comparator in this trial, in the secondary endpoints such as duration of response (DoR) and control of intracranial disease. Iruplinalkib retained its safety profile that was established in previous studies.

Iruplinalkib inhibits anaplastic lymphoma kinase (ALK), which is highly expressed in cancer cells leading to uncontrollable proliferation.

INSPIRE trial design

The open-label randomised INSPIRE trial (CTR20191231) enrolled 292 patients with ALK-positive NSCLC who had not been previously treated with ALK tyrosine kinase inhibitors.

The trial evaluated the safety and efficacy of oral 180mg once-daily dose of iruplinalkib versus oral 250mg twice-daily dose of crizotinib. The treatment cohort had a seven-day lean-in phase of 60mg once-daily dose of iruplinalkib.

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By GlobalData

The trial was conducted across 40 hospitals in China and led by investigator Yuankai Shi, a professor at the Cancer Hospital Chinese Academy of Medical Sciences.

On 28 June, the China National Medical Products Administration (NMPA) approved QiLu’s oral iruplinalkib for market launch to treat patients with metastatic ALK-positive NSCLC who had progressed or are intolerant to crizotinib.

QiLu has already submitted a new drug application for iruplinalkib as a first-line treatment for the same patient population. The application has been accepted by the NMPA’s Center for Drug Evaluation.

QiLu’s NSCLC pipeline

QiLu has two other ongoing Phase III clinical trials in NSCLC that are investigating QL1706. QL1706 is a bifunctional antibody for immunotherapy that is a combination of iparomlimab and tuvonralimab.

The DUBHE-L-304 (NCT05487391) is a randomised, double-blind, placebo-controlled trial. QiLu plans to enrol 632 patients with completely resected stage II-IIIB NSCLC without EGFR-sensitive mutations and ALK fusion genes.

Participants will receive 16 cycles of QL1706 or placebo in combination with two to four cycles of adjuvant chemotherapy. The primary endpoints are measuring investigator-assessed disease-free survival (DFS).

The double-blind, randomised, active-controlled DUBHE-L-303 (NCT05690945) trial plans to enol 650 patients with PD-L1-negative, stage IIIB-IV NSCLC without EGFR/ALK mutations.

Patients will receive either four cycles of QL1706 or tislelizumab plus chemotherapy. This will be followed by maintenance treatment with QL1706 or tislelizumab. The primary endpoints are evaluating PFS and overall survival.

Both DUBHE trials are conducted in research centres across China.