Luye Pharma Group announced the launch of its innovative drug Zepzelca® (lurbinectedin) for the treatment of SCLC in both Hong Kong and Macao, the two Special Administrative Regions of China. Lurbinectedin is a new chemical entity with a novel mechanism of action. It was approved for launch in Macao in November 2023 and in Hong Kong in December 2023 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy.

The drug was also approved by the U.S. Food and Drug Administration (FDA) through the accelerated approval process in 2020. Lurbinectedin has overcome a bottleneck in the second-line treatments of SCLC: SCLC is one of the most aggressive lung cancers, with a five-year survival rate of only 7%. Most patients would experience a relapse or develop drug resistance after the initial treatment, with an mOS (median Overall Survival) of only 4 to 5 months after receiving further chemotherapy.

Promising results for Chinese patients in a clinical study: The approval of lurbinectedin in countries and regions including the U.S., Hong Kong and Macao is mainly based on an open-label, multicenter and single-arm study (a Phase 2 basket trial) in 105 adult patients with SCLC (including both platinum-sensitive and platinum-resistant patients) who experienced disease progression after receiving platinum-based chemotherapy. In this trial, they were treated with lurbinectedin alone by receiving 1-hour intravenous infusion of the drug every 3 weeks at a dose of 3.2mg/m2. The study was published in The Lancet Oncology.

It demonstrated an ORR (Overall Response Rate) of 35.2%, an mDoR (median Duration of Response) of 5.3 months, and an mOS of 9.3 months for all patients treated with lurbinectedin. A single-arm, Phase 1 clinical study with dose escalation and expansion for lurbinectedin was conducted, to evaluate its safety, tolerability, pharmacokinetics (PK) and preliminary efficacy in Chinese patients with advanced solid tumors, including recurrent SCLC. The study showed an ORR of 45.5%, an mDoR of 4.2 months, and an mOS of 11.0 months for SCLC patients treated with lurbinectedin (at the FDA-approved dose of 3.2 mg/m2 via 1-hour intravenous infusion every 3 weeks).

Helping to make innovative drugs more accessible for patients: To date, lurbinectedin has been approved for launch in 16 countries and regions worldwide. Luye Pharma has been granted the rights to develop and commercialize lurbinectedin in Chinese mainland, Hong Kong, and Macao, to allow Chinese patients to benefit from the innovative therapy as soon as possible. In addition to being approved for launch in Hong Kong and Macao, the drug is also under review for its New Drug Application (NDA) in Chinese mainland with a priority review designation.