- This is the first clinical trial of Lurbinectedin in treating Chinese subjects.
- Lurbinectedin at the recommended dose showed promising efficacy as second-line therapy in Chinese patients with Small Cell Lung Cancer (SCLC), with acceptable tolerability and a manageable safety profile.
- As confirmed by an Independent Review Committee (IRC), the Overall Response Rate (ORR) was 45.5% in all the subjects and over 30% in those with resistant SCLC.
Shanghai, China, June 6, 2022 -- The preliminary results from a Phase I clinical trial of Lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer (SCLC) were presented at the 2022 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 6 local time in the form of a poster. Lurbinectedin is an investigational oncology drug licensed by PharmaMar to Luye Pharma Group for clinical development in China. The Phase I clinical trial of the drug currently going on in China is led by Luye Pharma.
The ASCO annual meeting each year presents the cutting-edge research results in clinical oncology and the latest cancer therapies. It is one of the world’s most influential and prominent scientific gatherings of the clinical oncology community. This year’s ASCO annual meeting is being held in Chicago both online and in person during June 3-7, 2022.
Lurbinectedin is a selective inhibitor of oncogenic transcription. It was granted accelerated approval in 2020 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic SCLC with disease progression on or after receiving platinum-based chemotherapy. The poster presented at this year’s ASCO annual meeting is entitled “Efficacy and Safety of Lurbinectedin as Second-line Therapy in Chinese Patients with Small Cell Lung Cancer: Preliminary Results of a Phase 1 Study”. Main results of the study are as follows:
- Lurbinectedin at the Recommended Dose (3.2mg/m2, intravenous injection within 1 hour, administered once every 3 weeks) showed promising efficacy as second-line therapy in Chinese patients with SCLC. It was confirmed by an Independent Review Committee (IRC) that the Overall Response Rate (ORR) was 45.5% in all the subjects and over 30% in those with resistant SCLC, and the median Progression-Free-Survival (PFS) was 6.6 months.
- Lurbinectedin demonstrated acceptable tolerability and a manageable safety profile.
The Phase I clinical trial in China is an open-label, single-arm, and dose-escalation/expansion study, designed to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of Lurbinectedin in Chinese patients with advanced solid tumors including relapsed SCLC. The study includes two stages: a dose-escalation stage with the primary objective to determine the recommended dose for Lurbinectedin, followed by an expansion stage where patients with relapsed SCLC are treated with Lurbinectedin at the recommended dose determined during the escalation stage. This is the first clinical trial of Lurbinectedin in treating Chinese subjects.
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About Lurbinectedin
Lurbinectedin is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor.
To date, Lurbinectedin has received the accelerated approval in the U.S., and provisional marketing approval in Australia, the United Arab Emirates, Canada, and Singapore, for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after receiving platinum-based chemotherapy.
About Lurbinectedin’s Development in China
In 2019, Luye Pharma Group was exclusively licensed by PharmaMar to develop and commercialize Lurbinectedin in China, covering all indications including SCLC. In addition, Luye Pharma holds the right to request the transfer of the manufacturing technology for Lurbinectedin from PharmaMar within the valid licensing period, so that Luye Pharma can produce the drug locally in China. Luye Pharma has submitted a New Drug Application for Lurbinectedin in Hong Kong, China.
About PharmaMar
PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.
PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (Lurbinectedin), in the US and China; and Aplidin® (Plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: Lurbinectedin and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
