Jenkem Technology (688356.SH) announced on September 4th that the safety, tolerability, and preliminary efficacy of the injection-grade polyethylene glycol ilatinib (pharmaceutical code: JK1201I) developed by its wholly-owned subsidiary, Tianjin Jenkem Technology Co., Ltd., for second-line monotherapy for small cell lung cancer, has been published in the international academic journal 'Cancer Medicine' (impact factor 4.0).
Polyethylene glycol ilatinib (JK1201I) is a class 1 innovative chemical drug independently developed by the company. The drug is a novel chemical drug obtained by modifying ilatinib with polyethylene glycol. In preclinical trials, JK1201I demonstrated better efficacy and safety than commercially available ilatinib hydrochloride. Phase I clinical trials conducted in advanced solid tumor patients have also shown good safety and tolerability of JK1201I, and achieved partial relief in small cell lung cancer patients. As of the date of this announcement, there is no marketed drug with the same indication worldwide.
This trial adopts a multicenter, open-label design, including two stages of dose escalation and dose expansion. A total of 33 subjects were screened in this study, and 29 eligible subjects were successfully enrolled. All 29 enrolled subjects received the investigational drug treatment. The statistical analysis results of this study completed to date show that JK1201I is well tolerated in patients with extensive-stage small cell lung cancer in the second-line treatment. Among the 26 evaluable subjects included in the efficacy analysis set (180mg/m2 group: 24 subjects, 220mg/m2 group: 2 subjects), the median overall survival (OS) in the 180mg/m2 group reached 12.1 months, showing a tendency to prolong patient survival, and is expected to benefit patients from treatment. With encouraging research data, more detailed data on this clinical trial have been published in the international academic journal 'Cancer Medicine'. In addition, a Phase II clinical trial of JK1201I in combination with temozolomide for the treatment of glioblastoma is still ongoing.
