Shanghai, July 17, 2022 — Luye Pharma Group today announced that Lurbinectedin, an innovative anticancer drug, has been approved by the Hainan Medical Products Administration for urgent clinical use at the Boao Future Hospital in the Hainan Boao Lecheng International Medical Tourism Pilot Zone. The drug is approved for treating adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy. The progress on the treatment of relapsed SCLC has been limited over the past two decades. The approval of Lurbinectedin will provide a new option for SCLC patients in China.
SCLC has a high risk of relapse, and second-line treatments only provide limited benefits for patients
According to the International Agency for Research on Cancer (IARC), lung cancer was China’s No.1 cancer in 2020 in terms of morbidity and mortality with 815,000 new cases and 714,000 deaths that year1. Specifically, SCLC is a high-grade neuroendocrine carcinoma, accounting for 13%-17% of all lung cancer cases2. It is also very likely to metastasize to distant sites in the body early on, and patients are often already in an advanced stage upon diagnosis, resulting in poor prognosis. The five-year survival rate of patients with SCLC is only 7% or as low as 3% for those in the extensive stage3.
Although SCLC is very sensitive to the initial treatment, most patients would experience a relapse or develop drug resistance after the initial treatment. Even with further chemotherapy, their median Overall Survival (OS) will be only 4-5 months2, and approximately 75% of the patients with locally advanced SCLC and more than 90% of those with metastatic SCLC will relapse within 2 years after receiving the treatment4.
Lurbinectedin is a new breakthrough in the second-line treatment of SCLC
In 2020, Lurbinectedin received the accelerated approval from the U.S. Food and Drug Administration (FDA) for treating adult patients with metastatic SCLC with disease progression on or after receiving platinum-based chemotherapy. For over 20 years prior to that, the FDA approved only one new chemical entity in 1996 for the treatment of relapsed SCLC.
The accelerated approval was based on clinical data from an open-label, multicenter, and single-arm study of Lurbinectedin in 105 adult patients with SCLC (including those who are platinum-sensitive and platinum-resistant) whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an Overall Response Rate (ORR) of 35%, a median Duration of Response (DoR) of 5.3 months, and a median OS of 9.3 months.
The Phase I clinical trial of Lurbinectedin in Chinese mainland is wrapping up. The preliminary results of this study showed that Lurbinectedin at the recommended dose (3.2mg/m2, intravenous injection within 1 hour, administered once every 3 weeks) demonstrated promising efficacy as second-line therapy in Chinese patients with SCLC. It was confirmed by an Independent Review Committee that the 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. In addition, Lurbinectedin also demonstrated good tolerability and manageable adverse reactions
Thanks to government policies, Lurbinectedin was approved in Boao first
Since June 2020, Lurbinectedin has received marketing authorization in the U.S., UAE, Canada, Australia, Singapore and Qatar. Lurbinectedin was also recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (published in 2021) and the NCCN Guidelines for Small Cell Lung Cancer (2022).
The management of Luye Pharma Group said: “SCLC is highly malignant and aggressive, with huge unmet needs from patients. Thanks to the favorable policies adopted by the Hainan Free-Trade Port on a pilot basis, Chinese patients now can benefit from Lurbinectedin, which is an advanced new therapy for SCLC in the world, within the pilot zone in Lecheng, Boao, without having to travel abroad. Apart from getting the approval in Boao, the company has also submitted a New Drug Application (NDA) for Lurbinectedin in Hong Kong, and will submit another one in Chinese mainland soon, hoping that more and more patients will be able to benefit from this innovative therapy as soon as possible.”
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 marketing authorization in the U.S., Australia, UAE, Canada, Singapore and Qatar for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after receiving platinum-based chemotherapy. Luye Pharma Group owns the rights to develop and commercialize Lurbinectedin in China. The company filed a New Drug Application(NDA) for Lurbinectedin in Hong Kong in March 2022, and will file another one in Chinese mainland soon.
1.International Agency for Research on Cancer – Population Fact Sheets – China. Available at https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed in July 2022.
2.The 2022 Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Small Cell Lung Cancer. People’s Medical Publishing House. 2022
3.Cancer.Net. Lung Cancer - Small Cell. Available at https://www.cancer.net/cancer-types/33776/view-all. Accessed in July 2022.
4. Rudin CM, et al. Nat Rev Dis Primers. 2021 Jan 14;7(1):3.