Qilu Pharmaceutical's First Innovative Drug Irualkib (WX-0593) Approved for ALK-Positive NSCLC

On June 28, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical's Class 1 innovative drug, Iruac kinase inhibitor, has been approved for marketing. It is indicated for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after prior treatment with crizotinib or are intolerant to crizotinib. This marks the first innovative drug developed by Qilu Pharmaceutical to be approved for market.

Iruac (R&D code: WX-0593) is a novel ALK/ROS1 inhibitor independently developed by Qilu Pharmaceutical. It can inhibit the activity of ALK kinase in wild-type and different fusion types, as well as ALK inhibitor-resistant mutations, while effectively inhibiting the activity of ROS1 kinase with different fusion types. Studies have shown that WX-0593 exhibits antitumor activity in ALK-positive or ROS1-positive NSCLC, with acceptable safety. Dose regimens within 180mg demonstrate excellent pharmacokinetic parameters and safety.

This approval for marketing is based on a single-arm, multi-center Phase II clinical study aimed at evaluating the efficacy and safety of Irulak in ALK mutation-positive advanced non-small cell lung cancer patients previously treated with crizotinib. The trial enrolled a total of 146 patients, with a median follow-up time of 9.3 months; 90 patients had brain metastases, including 41 with measurable intracranial lesions, and 20 patients had previously received brain radiotherapy; 56 patients had previously undergone chemotherapy.

The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1; secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), time to progression (TTP), and safety.

The results showed that, as assessed by IRC, the ORR of the Iruac treatment group was 67.8%, and the DCR was 96.6%. As assessed by investigators, the ORR of the Iruac treatment group was 61.6%, the DCR was 94.5%, the median DoR was 13.1 months, the median PFS/TTP was 14.4 months, and the 18-month overall survival rate was 81.9%.

Subgroup analysis found that the ORR assessed by IRC was slightly higher in patients without brain metastasis (79% vs 61%) and in those who had previously received brain radiotherapy (66% vs 45%); it was also slightly higher in patients who had or had not previously received chemotherapy (71% vs 66%); the iORR (intracranial objective response rate) for patients with measurable intracranial lesions was 63%; OS data are not yet mature.

Among the enrolled patients, 134 (91.8%) experienced treatment-related adverse events, the most common being elevated aspartate aminotransferase, alanine aminotransferase, and creatine phosphokinase levels.

Notably, in early April this year, the new indication application for Iruka tablets for ROS1-positive NSCLC was also accepted by the pharmaceutical regulatory authority. Previously published research results for this indication showed that, in 50 patients who had not previously used crizotinib,Iruac's ORR was 74% (37/50), and DCR was 96% (48/50).The median duration of response was 14.51 months. Iruac showed efficacy signals in patients resistant to crizotinib, with 2 out of 9 patients achieving partial response and a 6-month response rate of 100%.

According to the PharmaCube database, as of now, 8 ALK inhibitor drugs have been approved for marketing in China. Apart from Iruac, Pfizer's Crizotinib, Novartis/AstraZeneca's Ceritinib, Takeda’s Brigatinib, Roche's Entrectinib, Betta Pharmaceuticals' Ensartinib, Pfizer/CStone’s Lorlatinib, and Chugai's Alectinib have all been approved for marketing.

According to the official press release, Qilu Pharmaceutical has a total of 129 products that have passed the consistency evaluation, of which 51 are the first in China. It is undoubtedly a leading player in the first-to-market generics sector. Nowadays, innovative products are also bearing fruit one after another. In addition to Iruka, which took the lead, Qilu’s product pipeline includes more than 50 innovative drugs. Among them, EGFR antibody QL1203, PD-1/CTLA-4 bispecific antibody QL1706, Moxetumomab, and PD-1 antibody have all entered Phase III clinical trials, with several others in Phase I~II.

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