Macao, August 21, 2023 – Luye Pharma today announced that it has filed a New Drug Application (NDA) in Macao for Lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.
Lurbinectedin is a selective inhibitor of oncogenic transcription. Its unique dual-action mechanism allows it to regulate the microenvironment for tumors while inhibiting oncogenic transcription and causing the apoptosis of cancer cells. In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the above-mentioned indication.
The NDA filed in Macao is based on data from two clinical studies of Lurbinectedin conducted in China and overseas. The study conducted overseas is an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC (including platinum-sensitive and platinum-resistant ones) whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an overall response rate(ORR) of 35% and a median Duration of Response (DoR) of 5.3 months.
The study conducted in China is a single-arm, dose-escalation, and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced tumors including relapsed SCLC. This study shows a promising efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients. An Independent Review Committee confirmed that the ORR was 45.5% in subjects with relapsed SCLC.
Lung cancer is one of the malignancies with high morbidity and mortality rates worldwide, and SCLC accounts for 13%-17% of all lung cancer cases. SCLC is highly likely to metastasize to distant sites within the body in early stages, and patients are often already in an advanced stage upon diagnosis, resulting in poor prognosis1. Meanwhile, there has been limited progress in treating SCLC. For over 20 years prior to the Accelerated Approval of Lurbinectedin, the FDA approved only one new chemical entity for the treatment of metastatic SCLC in 1996.
“SCLC is a type of lung cancer that is highly malignant and relatively difficult to treat, characterized by poor prognosis and a high relapse rate,” said Yang Rongbing, President of Luye Pharma Group. “The main challenge in treating this disease today is the lack of new drugs to treat it after a relapse. We’re excited to file an NDA for Lurbinectedin in Macao. An approval there would potentially allow the drug to be used in the entire Guangdong-Hong Kong-Macao Greater Bay Area. Meanwhile, the drug’s NDA is also under review in Hong Kong and the Chinese mainland. We hope that this innovative therapy will be made available to more patients in need as soon as possible, to improve their survival.”
Lurbinectedin was originally developed by Luye Pharma’s partner PharmaMar. Luye Pharma was granted the exclusive rights to develop and commercialize the drug in China.
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About Lurbinectedin
Lurbinectedin is an analog of the marine compound ET-736 isolated from 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 tumors.
Lurbinectedin has also been approved in over 10 other countries and regions, in addition to its Accelerated Approval by the U.S. FDA for the treatment of metastatic SCLC. The drug has been recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (published in 2021), the NCCN Guidelines for Small Cell Lung Cancer (2022), and the 2023 Chinese Society of Clinical Oncology Guidelines for Small Cell Lung Cancer. Luye Pharma owns the rights to develop and commercialize Lurbinectedin in China.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
Macao, August 21, 2023 – Luye Pharma today announced that it has filed a New Drug Application (NDA) in Macao for Lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.
Lurbinectedin is a selective inhibitor of oncogenic transcription. Its unique dual-action mechanism allows it to regulate the microenvironment for tumors while inhibiting oncogenic transcription and causing the apoptosis of cancer cells. In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the above-mentioned indication.
The NDA filed in Macao is based on data from two clinical studies of Lurbinectedin conducted in China and overseas. The study conducted overseas is an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC (including platinum-sensitive and platinum-resistant ones) whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an overall response rate(ORR) of 35% and a median Duration of Response (DoR) of 5.3 months.
The study conducted in China is a single-arm, dose-escalation, and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced tumors including relapsed SCLC. This study shows a promising efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients. An Independent Review Committee confirmed that the ORR was 45.5% in subjects with relapsed SCLC.
Lung cancer is one of the malignancies with high morbidity and mortality rates worldwide, and SCLC accounts for 13%-17% of all lung cancer cases. SCLC is highly likely to metastasize to distant sites within the body in early stages, and patients are often already in an advanced stage upon diagnosis, resulting in poor prognosis1. Meanwhile, there has been limited progress in treating SCLC. For over 20 years prior to the Accelerated Approval of Lurbinectedin, the FDA approved only one new chemical entity for the treatment of metastatic SCLC in 1996.
“SCLC is a type of lung cancer that is highly malignant and relatively difficult to treat, characterized by poor prognosis and a high relapse rate,” said Yang Rongbing, President of Luye Pharma Group. “The main challenge in treating this disease today is the lack of new drugs to treat it after a relapse. We’re excited to file an NDA for Lurbinectedin in Macao. An approval there would potentially allow the drug to be used in the entire Guangdong-Hong Kong-Macao Greater Bay Area. Meanwhile, the drug’s NDA is also under review in Hong Kong and the Chinese mainland. We hope that this innovative therapy will be made available to more patients in need as soon as possible, to improve their survival.”
Lurbinectedin was originally developed by Luye Pharma’s partner PharmaMar. Luye Pharma was granted the exclusive rights to develop and commercialize the drug in China.
###
About Lurbinectedin
Lurbinectedin is an analog of the marine compound ET-736 isolated from 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 tumors.
Lurbinectedin has also been approved in over 10 other countries and regions, in addition to its Accelerated Approval by the U.S. FDA for the treatment of metastatic SCLC. The drug has been recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (published in 2021), the NCCN Guidelines for Small Cell Lung Cancer (2022), and the 2023 Chinese Society of Clinical Oncology Guidelines for Small Cell Lung Cancer. Luye Pharma owns the rights to develop and commercialize Lurbinectedin in China.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
