Luye Pharma Launches Zepzelca in Regions of China

Luye Pharma Launches Zepzelca in Regions of China

By, Admin 9 March 2024

Luye Pharma Launches Zepzelca® (Lurbinectedin) in Hong Kong and Macao

Overview

In a recent symposium organized by the Hong Kong Cancer Therapy Society (HKCTS) and supported by Luye Pharma Group (Luye Pharma), a significant announcement was made regarding the treatment of Small Cell Lung Cancer (SCLC). Luye Pharma unveiled its innovative drug, Zepzelca® (lurbinectedin), for SCLC treatment in Hong Kong and Macao.

About Lurbinectedin

  • Lurbinectedin is a novel drug approved for metastatic SCLC patients who have experienced disease progression after platinum-based chemotherapy. 
  • It received approval in Macao in November 2023 and in Hong Kong in December 2023, marking a notable advancement in SCLC treatment, as it is the first new chemical entity approved by the U.S. FDA for relapsed SCLC in over two decades.

SCLC

  • SCLC is notorious for its aggressiveness and poor survival rates. 
  • Patients often experience relapse or drug resistance after initial treatment, leading to a median Overall Survival (mOS) of only 4 to 5 months.
  • Dr. Herbert Loong, from the Chinese University of Hong Kong and a council member of HKCTS, emphasized the urgent need for effective second-line treatments for SCLC. He highlighted lurbinectedin's selective inhibition of oncogenic transcription as a promising approach to improve patient survival.

Phase 2 Trial

  • Clinical studies, including an open-label Phase 2 trial, demonstrated lurbinectedin's efficacy in both platinum-sensitive and platinum-resistant SCLC patients. 
  • Notably, it showed an Overall Response Rate (ORR) of 35.2%, a median Duration of Response (mDoR) of 5.3 months, and an mOS of 9.3 months.

Praise from Expert

Dr. Antonio Calles from Hospital General Universitario Gregorio Marañón in Madrid, Spain, praised lurbinectedin's superiority over standard treatments and its potential in combination therapies to benefit SCLC patients.

Result Values

Furthermore, a Phase 1 clinical study in Chinese patients showed promising results, with an ORR of 45.5%, mDoR of 4.2 months, and mOS of 11.0 months.

Professor Sheng Ye from the First Hospital of Sun Yat-sen University highlighted lurbinectedin's potential as a valuable treatment option for Chinese SCLC patients based on its performance in local clinical trials.

Efforts for Wider Approval

  • Expanding access to innovative treatments, Luye Pharma aims to make lurbinectedin available to patients in various countries and regions worldwide. 
  • With efforts underway to secure approval in the Chinese mainland and expedite patient access, the introduction of Zepzelca in Hong Kong and Macao signifies a significant step towards improving outcomes for SCLC patients.

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