December 3, 2024，the innovative drug Zepzelca (lurbinectedin for injection) has been approved for marketing by China’s National Medical Products Administration (NMPA) through the priority review program. The drug is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Zepzelca is a selective inhibitor of oncogenic transcription. While inhibiting oncogenic transcription, it regulates the microenvironment for tumors and leads to the apoptosis of tumor cells. The drug was also approved by the U.S. Food and Drug Administration (FDA) through its Accelerated Approval Program in 2020. For 27 years, it has been the only new chemical entity approved by the FDA for the treatment of relapsed SCLC since 1997.
The approval of Zepzelca by the NMPA was based on the results of two clinical studies. One of them was a pivotal study conducted overseas, an open-label, multicenter, and single-arm study (a Phase 2 basket trial) in adult patients with SCLC (including both platinum-sensitive and platinum-resistant patients) who experienced disease progression after receiving platinum-based chemotherapy. In this study, they were treated with Zepzelca alone through intravenous infusion of the drug every 3 weeks at a dose of 3.2 mg/m2. The study was published in The Lancet Oncology, which demonstrated an overall response rate (ORR) of 35.2%, a median duration of response (mDoR) of 5.3 months, a median progression-free survival (mPFS) of 3.5 months, and an mOS of 9.3 months for all patients treated with Zepzelca . The other study was a single-arm, bridging clinical study with dose escalation and expansion for Zepzelca 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, an mPFS of 5.6 months and an mOS of 11.0 months for SCLC patients treated with Zepzelca through intravenous infusion every 3 weeks at a dose of 3.2 mg/m2.
The two studies above demonstrated significant antitumor activity for Zepzelca as a second-line treatment for SCLC with a manageable safety profile. In addition, the study conducted in the Chinese population demonstrated better patient outcomes.
Additionally, Zepzelca is also being investigated in multiple international clinical trials. In a Phase 1/2 study, Zepzelca in combination with atezolizumab demonstrated an ORR of 66.67%, an mPFS of 4.7 months, and an mOS of 14.5 months when used as a second-line treatment for patients with extensive-stage SCLC. In another Phase 1/2 study, Zepzelca combined with pembrolizumab showed an ORR of 46.4%, an mPFS of 5.3 months, and an mOS of 11.1 months as a second-line treatment for patients with relapsed SCLC. Furthermore, clinical studies involving Zepzelca in combination with an immune checkpoint inhibitor as the first-line maintenance therapy for SCLC, in combination with chemotherapy for the treatment of relapsed SCLC, and for the treatment of leiomyosarcoma are also underway. These studies are designed to continue exploring the clinical application and therapeutic potential of the drug.
To date, Zepzelca has been approved for marketing in 17 countries and regions worldwide. Luye Pharma has been granted the rights to develop and commercialize this drug in the Chinese mainland, Hong Kong, and Macao, and has received marketing approval for the drug in these three regions.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.2024年12月03日药品批准证明文件送达信息 (nmpa.gov.cn)
2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® （注射用芦比替定）获得国家药品监督管理局上市批准 – 新闻动态 – 绿叶 – 绿叶制药集团 (luye.cn)
Post time: Jan-14-2025