Lipusu (liposomal paclitaxel) / Luye Group - LARVOL DELTA

ORIENTA: Organoid-based Functional Precision Therapy for Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Guangdong Provincial People's Hospital | Initiation date: Jan 2024 ➔ Sep 2024

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

The efficiency of Liposomal paclitaxel versus docetaxel in neoadjuvant chemotherapy with TPF regimen for locally advanced nasopharyngeal carcinoma: a retrospective study (Front Oncol) - "This retrospective study included 115 patients diagnosed with nasopharyngeal carcinoma (NPC) at our hospital between January 2018 and December 2021....ORR was significantly improved in the liposomal paclitaxel group than in the docetaxel group (62.0% versus 40.9%, P = 0.028). The 3-year PFS (PFS: 84.4% versus 77.5%, P = 0.303), LRFS (95.8% versus 94.4%, P = 0.810), DMFS (87.2% versus 83.0%, P = 0.443), and OS (90.7% versus 88.8%, P = 0.306) revealed no significance. The neutrophil-to-lymphocyte ratio (hazard ratio [HR]: 3.510; P = 0.039) and distant metastasis (HR: 4.384; P = 0.035) were regarded as the risk factors using multivariate regression analysis."

Retrospective data • Nasopharyngeal Carcinoma

Quantitative and Dynamic ctDNA as a Biomarker of Response and Survival in Treatment-Naive Patients with Advanced Lung Squamous Cancer (IASLC-WCLC 2024) - P3, P4 | "Methods : This post-hoc analyses were performed in two independently conducted trials: Camel-Seq (NCT03668496) (Cohort A) and LIPUSU (NCT02996214) (Cohort B)...More importantly, MinerVa-Delta is able to accurately identify SD patients, a heterogeneous patient population in clinic, who can benefit from the initial treatment. This makes it a valuable supplement to the current image-based RECIST classification system."

Biomarker • Circulating tumor DNA • Clinical • IO biomarker • Metastases • Non Small Cell Lung Cancer • Oncology • KEAP1

Quantitative and Dynamic ctDNA as a Biomarker of Response and Survival in Treatment-Naive Patients with Advanced Lung Squamous Cancer (IASLC-WCLC 2024) - P3, P4 | "Methods : This post-hoc analyses were performed in two independently conducted trials: Camel-Seq (NCT03668496) (Cohort A) and LIPUSU (NCT02996214) (Cohort B)...More importantly, MinerVa-Delta is able to accurately identify SD patients, a heterogeneous patient population in clinic, who can benefit from the initial treatment. This makes it a valuable supplement to the current image-based RECIST classification system."

Biomarker • Circulating tumor DNA • Clinical • IO biomarker • Metastases • Non Small Cell Lung Cancer • Oncology • KEAP1

ALTER-GO-010: Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: Wenjun Cheng | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Sep 2025

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Endocrine Disorders • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Ginsenoside Rh2-Based Multifunctional Liposomes for Advanced Breast Cancer Therapy. (PubMed, Int J Nanomedicine) - "In in vivo study, PTX-Rh2-lipo effectively inhibiting the growth of advanced breast tumors and outperformed most reported PTX formulations, including Lipusu® and Abraxane®. Rh2-lipo have improved drug delivery efficiency and antitumor efficacy in advanced breast cancer, which offers a novel promising platform for advanced tumor therapy."

Journal • Metastases • Breast Cancer • Oncology • Solid Tumor

Paclitaxel liposome (Lipusu) based chemotherapy combined with immunotherapy for advanced non-small cell lung cancer: a multicenter, retrospective real-world study. (PubMed, BMC Cancer) - "Paclitaxel liposome based chemotherapy plus PD-1/PD-L1 inhibitor prolonged the PFS in advanced NSCLC with acceptable safety, which was worthy of clinical application."

Journal • Metastases • Real-world • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Transforming a Toxic Non-Ionizable Drug into an Efficacious Liposome via Ionizable Prodrug and Remote Loading Strategies against Malignant Breast Tumors. (PubMed, Mol Pharm) - "Due to its non-ionizable and water-insoluble characteristics, the drug-loading efficiency of the marketable PTX lipos, Lipusu, is only 6.76%...A series of in vitro/vivo experiments indicated that PTXP lipos possess colloidal stability, prolonged blood circulation, high tumor site accumulation, potent anti-tumor effects, and safety. A combination of ionizable prodrugs and remote loading has proved to be an effective and simple strategy to achieve high liposomal encapsulation efficiency of poorly soluble non-ionizable drugs for clinical application."

Journal • Breast Cancer • Oncology • Solid Tumor

Strategies for the drug discovery and development of taxane anticancer therapeutics. (PubMed, Expert Opin Drug Discov) - "As epoch-making anticancer drugs, paclitaxel and docetaxel have been extensively used in the clinic over the past three decades...Inspired by the notable success of Abraxane and Lipusu, new formulations have been extensively developed...In order to mitigate undesirable side effects, the exploration of effective nanoformulations and tumor-targeted drug delivery systems are essential. Therefore, it is expected that these research programs will be the major focus in taxane-based drug development for years to come."

Journal • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

A facile method for anti-cancer drug encapsulation into polymersomes with a core-satellite structure. (PubMed, Drug Deliv) - "Compared with commercial liposomal PTX formulation (Lipusu), PTX@PS exhibited superb tumor cell killing ability underlain by multiple pro-apoptotic mechanisms. Moreover, endocytic process of PTX@PS significantly inhibits drug transporter P-gp expression which could be largely activated by free drug diffusion. In glioma mice models, it has also confirmed that PTX@PS remarkably eradicate tumors, which renders polymersomes as a promising alternative to liposomes as drug carriers in clinic."

Journal • Brain Cancer • Glioma • Oncology • Solid Tumor

Engineering Lipusu with lysophosphatidylcholine for improved tumor cellular uptake and anticancer efficacy. (PubMed, J Mater Chem B) - "Furthermore, stronger tumor growth inhibition was observed in LPC-Lip treated 4T1 tumor-bearing mice without significant side effects. In conclusion, by modulating the lipid composition of Lip, the antitumor efficacy can be improved, and LPC engineered Lip may serve as a promising formulation of PTX for future cancer therapy."

Journal • Breast Cancer • Oncology • Solid Tumor

Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. (PubMed, Cancer Commun (Lond)) - "The LP regimen demonstrated similar PFS, OS, ORR and DCR as the GP regimen for patients with locally advanced or metastatic LSCC but had more favorable toxicity profiles. The study also identified a spectrum of different cytokines that could be potentially associated with the clinical benefit in patients who received the LP regimen."

Clinical • Journal • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CXCL8 • IFNG • IL6 • TNFA

A Review on Nano-Based Drug Delivery System for Cancer Chemoimmunotherapy. (PubMed, Nanomicro Lett) - "Several nanocarriers have been approved in clinical cancer chemotherapy and showed significant improvement in therapeutic efficiency compared with traditional formulations, such as liposomes (Doxil, Lipusu), nanoparticles (Abraxane) and micelles (Genexol-PM). The applications of NDDS to chemoimmunotherapy would be a powerful strategy for future cancer treatment, which could greatly enhance the therapeutic efficacy, reduce the side effects and optimize the clinical outcomes of cancer patients. Herein, the current approaches of cancer immunotherapy and chemoimmunotherapy were discussed, and recent advances of NDDS applied for chemoimmunotherapy were further reviewed."

Journal • Review • Oncology

Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2; N=56; Not yet recruiting; Sponsor: Wenjun Cheng

Clinical • New P2 trial • Endocrine Disorders • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Population Pharmacokinetics and Exposure-Safety Relationship of Paclitaxel Liposome in Patients With Non-small Cell Lung Cancer. (PubMed, Front Oncol) - "Paclitaxel liposome (Lipusu) is the first commercialized liposomal formulation of paclitaxel...Predicted exposure of paclitaxel did not change in the presence of the traditional Chinese medicine, aidi injection. The exposure-safety analysis suggested that a higher risk of neutropenia was correlated with higher exposure to paclitaxel."

Clinical • Journal • PK/PD data • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

"#WCLC20 @IASLC 来自中国上海市肺科医院的周彩存教授，报告了注射用紫杉醇脂质体联合顺铂 vs 吉西他滨联合顺铂一线治疗晚期肺鳞癌的IV期临床研究（LIPUSU） LP组和GP组中位PFS分别为5.2 vs. 5.5月 LP组的OS较GP组的OS延长了2.1个月(14.6 vs. 12.5月)" (@Lynn_PengLing)

Novel ginsenoside-based multifunctional liposomal delivery system for combination therapy of gastric cancer. (PubMed, Theranostics) - "The combination therapy using these targeted liposomes significantly suppressed GC tumor growth and outperformed most reported PTX formulations, including Lipusu and Abraxane. We established novel ginsenoside-based liposomes as a tumor-targeting therapy, in which ginsenoside functioned not only as a chemotherapy adjuvant, but also as a functional membrane material. Ginsenoside-based liposomes offer a novel platform for anticancer drug delivery and may lead to a new era of nanocarrier treatments for cancer."

Combination therapy • Journal • Gastric Cancer • Gastrointestinal Cancer • Lip Cancer • Oncology • Solid Tumor

Lipusu recommended by CSCO guidelines on diagnosis and treatment of breast cancer as the first-line chemotherapy (Luye Pharma Press Release) - "The board of directors...of Luye Pharma Group Ltd...announce that, LIPUSU®, being the Group’s paclitaxel formulation with innovative liposome delivery system, has been recommended under the 2020 Chinese Society of Clinical Oncology....guidelines (the 'Guidelines') on diagnosis and treatment of breast cancer for first-line rescue chemotherapy for Her2-negative advanced breast cancer."

Clinical guideline • Breast Cancer • Oncology

Newly added product (Luye Pharma Press Release) - Marketed, Ovarian Cancer

Pipeline update • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU) (clinicaltrials.gov) - P4; N=536; Active, not recruiting; Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Chemotherapy drugs derived nanoparticles encapsulating mRNA encoding tumor suppressor proteins to treat triple-negative breast cancer. (PubMed, Nano Res) - "The PAL P53 mRNA NPs showed superior properties compared to Abraxane and Lipusu used in the clinic including high paclitaxel loading capacity (24 wt.%, calculated by paclitaxel in PAL), PAL encapsulation efficiency (94.7% ± 6.8%) and mRNA encapsulation efficiency (88.7% ± 0.7%). More importantly, we demonstrated in vivo anti-tumor efficacy of PAL P53 mRNA NPs in an orthotopic TNBC mouse model. Overall, these chemotherapy drugs derived mRNA NPs provide a new platform to integrate chemotherapy and personalized medicine using tumor genetic information, and therefore represent a promising approach for TNBC treatment."

Journal

Quantitative proteomic analysis to the first commercialized liposomal paclitaxel nano-platform Lipusu revealed the molecular mechanism of the enhanced anti-tumor effect. (PubMed, Artif Cells Nanomed Biotechnol) - "It was different from pharmaceutical issues about drug exposure, delivery and distribution which were widely investigated in other traditional studies. It was the first study about the drug effect of lip from the global molecular biological aspect."

Journal