China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing has been submitted to Macau’s medical products administration bureau for the company’s drug lurbinectedin (LY01017). The targeted indication is for the treatment of metastatic small-cell lung cancer (SCLC) in patients who experience tumor progression during or after platinum-based chemotherapy.
Clinical Study Results Support Filing
The filing is supported by data from two clinical studies conducted in China and overseas. A single-arm, dose-escalation, and expansion clinical study in China demonstrated significant anti-tumor efficacy and manageable safety for lurbinectedin when used in the second-line setting for Chinese SCLC patients. Among subjects with recurrent SCLC, the overall response rate (ORR), as evaluated by an independent evaluation committee, reached 45.5%. An open, multicenter, single-arm, Phase II study conducted overseas included 105 adult SCLC patients, both platinum sensitive and resistant, who had disease progression after platinum chemotherapy. This study showed an ORR of 35% and a median duration of remission (DoR) of 5.3 months for patients receiving lurbinectedin.
Lurbinectedin’s Mechanism and Rights Acquisition
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. In April 2019, Luye acquired exclusive development and commercialization rights to lurbinectedin for China through a licensing deal with Pharma Mar. The drug received conditional approval to treat SCLC in the US in 2020 and has since been approved in dozens of countries worldwide.-Fineline Info & Tech
