The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186) lurbinectedin (LY01017), an RNA polymerase II inhibitor, is set to obtain priority review status for the treatment of metastatic small cell lung cancer (SCLC) with tumor progression during or after platinum-based chemotherapy.
Development and Mechanism of Action
Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), selectively inhibits oncogenic transcription, promoting tumor cell death and normalizing the tumor microenvironment. Pharma Mar secured its first approval for lurbinectedin in the US in June 2020, marketed as Zepzelca, and has received temporary approvals in Australia, the United Arab Emirates, Canada, and Singapore for use in recurrent SCLC.
Clinical Trial Results and Luye’s Acquisition
In clinical trials, the overall response rate (ORR) of patients treated with lurbinectedin was as high as 35%, with a median duration of response (DoR) of 5.3 months. Luye Pharma acquired exclusive development and commercialization rights to lurbinectedin for China through a licensing deal with Pharma Mar in April 2019. A new drug application (NDA) was filed in Hong Kong in March 2022, and a Named Patient Program (NPP) was initiated in January this year. The drug was also approved in Hainan in July last year for urgent clinical use.
Phase I Study Results
Luye published the results of a Phase I study for lurbinectedin in advanced solid tumors, including SCLC, at the American Society of Clinical Oncology (ASCO) annual meeting in June last year. The study showed an objective response rate (ORR) of 45.5% in the second-line treatment of Chinese SCLC with lurbinectedin as a monotherapy, and the ORR for the drug-resistant relapse population also exceeded 30%. The median duration of remission (mDOR) was 4.0 months, the median progression-free survival (mPFS) was 6.6 months, and the median overall survival (mOS) had not yet been achieved. Additionally, lurbinectedin exhibited good tolerability and a controllable safety profile.-Fineline Info & Tech
