556P - Results from the phase I study on efficacy and safety of iruplinalkib (WX-0593) for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) patients who received prior second-generation ALK tyrosine kinase inhibitors (TKIs)

Background

Iruplinalkib (WX-0593) is a novel ALK TKI. Here, we report the results from the phase 1 study on efficacy and safety of iruplinalkib for ALK-positive NSCLC patients who received prior second-generation ALK TKIs.

Methods

ALK- or ROS1-positive advanced NSCLC patients were enrolled in the phase 1 study. In the dose-escalation phase, patients received iruplinalkib 30–300 mg orally once daily. In the dose-expansion phase, patients received iruplinalkib 120 or 180 mg orally once daily with or without a 7-day lead-in at 60 mg. Efficacy and safety were assessed by investigators. ALK-positive patients previously treated with second-generation ALK TKIs were included in this analysis.

Results

Totally, 153 patients were enrolled in the phase 1 study, among which 11 patients (five [45%] in the dose-escalation phase and six [55%] in the dose-expansion phase) who received prior second-generation ALK TKIs were eligible for this analysis. Median age was 52 years old. Six (55%) were male. There were one (9%), four (36%), four (36%) and two (18%) patients in 90 mg, 120 mg, 180 mg, and 240 mg orally once daily group of iruplinalkib, respectively. Brain metastasis and prior treatment were summarized in the table. As of the data cut-off date on July 31, 2023, median follow-up was 53.3 months. Six patients (55%, 95% confidence interval [CI] 23%–84%) had objective response. Median progression-free survival (PFS) was 8.1 months (95% CI 2.2–30.2). Nine (82%) and three (27%) patients experienced any grade and grade ≥ 3 treatment-related adverse event (TRAE), respectively. Other endpoints were shown in the table. Table: 556P

Conclusions

Iruplinalkib demonstrated promising efficacy and acceptable toxicity in ALK-positive advanced NSCLC patients previously treated with second-generation ALK TKIs.

Clinical trial identification

NCT03389815.

Editorial acknowledgement

We thank Yunjie Yu (Qilu Pharmaceutical Co., Ltd., Jinan, China) for providing medical writing support.

Legal entity responsible for the study

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs.

Funding

Qilu Pharmaceutical Co., Ltd. (Jinan, China) and China National Major Project for New Drug Innovation (2017ZX09304015).

Disclosure

M. Wang, M. Si, Y. Sang, X. Kang: Financial Interests, Personal, Full or part-time Employment: Qilu Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.