Shanghai, March 4, 2024 – Luye Pharma Group announced today that the first patient has been enrolled for a Phase 3 clinical trial of its investigational anticancer drug Irinotecan Hydrochloride Liposome Injection (LY01610). This is a multicenter, randomized, open-label, parallel-group study that will compare the efficacy and safety of LY01610 versus topotecan in patients with relapsed small cell lung cancer (SCLC).

LY01610 is expected to become a better treatment for relapsed SCLC. To date, there has been no irinotecan hydrochloride liposome injection approved for treating SCLC in China.

Chemotherapy is still the principal approach to controlling the progression of relapsed SCLC today, as for years there has been no therapy being able to clearly improve outcomes and prognoses. The 2023 Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of SCLC recommends topotecan as a standard second-line treatment for SCLC patients who have relapses within 6 months after receiving a first-line treatment, irinotecan hydrochloride in combination with a platinum-based therapy as a first-line treatment for extensive stage SCLC, and irinotecan hydrochloride alone as an alternative second-line treatment for SCLC.

However, the use of both topotecan and irinotecan hydrochloride has limitations in clinical practice. The efficacy of topotecan is modest -- the Objective Response Rate (ORR) is less than 25% for sensitive relapsed patients and less than 10% for resistant relapsed patients, and it can cause severe myelosuppression, leading to poor tolerability (with Grade 4 neutropenia occurring in up to 70% of patients)¹. Irinotecan hydrochloride exhibits significant toxicity against normal cells, and is prone to causing late diarrhea (with around 30% of Grade 3-4 TEAEs) and neutropenia (with 25% of Grade 3-4 TEAEs) (Note: In this study, the subjects treated with irinotecan hydrochloride were patients with colorectal cancer, but not SCLC)². 

LY01610 overcomes those limitations by innovatively encapsulating irinotecan hydrochloride in liposomes. The encapsulation ensures the structural integrity of the drug’s active ingredient and alters its in vivo pharmacokinetics and distribution. As a result, the blood concentrations of the drug and its active metabolites are significantly increased, leading to a longer half-life. The drug is also enriched in tumor tissues and reduced in other organs, to enhance efficacy and reduce toxicity.

LY01610 demonstrated promising efficacy and safety during Phase 1 and 2 clinical trials that had been completed. In the Phase 2 clinical trial for Chinese patients with relapsed SCLC, LY01610 was found to be superior to topotecan, the standard treatment for relapsed SCLC, in terms of ORR, Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS); when it came to safety, LY01610 was hematologically less toxic than topotecan, and caused fewer gastrointestinal adverse events such as diarrhea than irinotecan hydrochloride.

Lung cancer is the most common cancer and leading cause of cancer death in China, with about 1,060,600 new cases and 733,300 deaths in 2022³, and SCLC accounted for 13-17% of all the lung cancer cases⁴. SCLC is highly malignant, and patients are often in advanced stages upon diagnosis, resulting in a poor prognosis. The five-year survival rate for SCLC patients in the extensive stage is only 3%⁵, and approximately 75% of patients with locally advanced SCLC and over 90% of those whose cancer has metastasized would relapse within two years after receiving treatments⁶. 

“SCLC is a subtype of lung cancer that is relatively difficult to treat, and there are significant unmet needs of patients suffering from it,” said Yang Rongbing, President of Luye Pharma Group. “At Luye Pharma, we’ve been developing innovative formulations for years, with a competitive edge and strong expertise in liposomes and targeted drug delivery systems. With an innovative formulation, LY01610 has the potential to become a better treatment for relapsed SCLC. We’ll speed up its Phase 3 clinical trial to further prove its superiority. We’ll also continue to explore its potential in treating other diseases, to meet the unmet needs of patients.”

In addition to LY01610, Luye Pharma has also developed other liposomes and targeted drug delivery systems. For example, its exclusive product Lipusu^® (paclitaxel liposome injection), which has been launched, is widely recognized by physicians and patients in clinical practice for clear efficacy and better safety; and its Irinotecan Hydrochloride and Floxuridine Liposome Injection is the first investigational drug of its kind to apply for and undergo clinical trials in China.

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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.

 

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