Products

Genexol® PM Genexol® PM

Genexol®PM is a novel formulation of paclitaxel encompassing Samyang’s plant cell culture technology and proprietary Polymeric Micelle technology

Hydrophilic-Hydrophobic + paclitaxel

Genexol®PM Conventional paclitaxel
API Paclitaxel 30mg Paclitaxel 30mg
Solubilizer mPEG-PDLLA* 150 mg Cremophor 2,645mg
MTD 390 mg/m2 175 mg/m2
Pre-Med Not required in single agent therapy Required
Catheter Not needed Non-PVC sets with in-line filter
Character
  • Improved solubility
  • Reduced toxicity
  • Improved efficacy
  • Reduced hypersensitivity
  • Low MTD
  • Cremophor induced
    - Toxicity
    - Hypersensitivity reaction and neuropathy

* mPEG-PDLLA: monomethoxy-poly (ethylene glycol)-block-poly(D,L-lactide)

Clinical Studies - Summary

More than a dozen studies have been completed to attest to the safety and efficacy of Genexol®PM

PI Location No. of Patients MTD DLT
Korea 21 390 mg/m2 Neutropenia, Neuropathy, Myalgia
US 23 435 mg/m2 Diarrhea, Fatigue, Neutropenia
Singapore 24 200 mg/m2
Russia 18 300 mg/m2 Diarrhea, Neutropenia
PII Description No. of Patients Response Adverse Events (Grade 3 & 4)
  • Location: Korea
  • Patient: MBC
41 Response Rate: 59%, Median TTP: 9.0 m, Median OS: ≥ 20 m Neutropenia (68%), Alopecia (10%)
  • Location: Korea
  • Patient: NSCLC
69 Response Rate: 38%, Median TTP: 5.8 m, Median OS: 21.7 m Neutropenia (46%), Alopecia (2%)
  • Location: USA
  • Patient: Pancreatic Cancer
45 Response Rate: 6.7%, Median TTP: 3.2 m, Median OS: 6.5 m Neutropenia (40%), Leukopenia (8.9%)
  • Location: USA
  • Patient: OC
98 Response Rate: 88%, Median TTP: 14.8 m, Median OS: N.A. Neutropenia (18%), Leukopenia (4%)
PMS Description No. of Patients Response Adverse Events (Grade 3 & 4)
  • Location: Korea
  • Patient: MBC
132 Response Rate: 24% Neutropenia (4.5%)
  • Location: Korea
  • Patient: NSCLC
181(Efficacy) + 191(Safety) Response Rate: 50% Neutropenia (2.1%)

Related Articles (Published)

Source Title
Journal of Controlled Release 72 (2001) 191–202 In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy
Clinical Cancer Research Vol. 10, 3708–3716, June 1, 2004 Phase I and Pharmacokinetic Study of Genexol®-PM, a Cremophor-Free, Polymeric Micelle-Formulated Paclitaxel, in Patients with Advanced Malignancies
Breast Cancer Res Treat (2008) 108:241–250 Multicenter phase II trial of Genexol®-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer
Annals of Oncology 18: 2009–2014, 2007 Multicenter phase II trial of Genexol®-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer
Annals of Oncology 21: 382–388, 2010 Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors
Cancers 2011, 3, 17-42; Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics
Cancer Investigation, 28:186–194, 2010 Phase II Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients with Advanced Pancreatic Cancer
Cancer Chemother Pharmacol (2014) 74:277–282 A phase II trial of Cremorphor EL‑free paclitaxel (Genexol®‑PM) and gemcitabine in patients with advanced non‑small cell lung cancer
Int J Radiation Oncol Biol Phys, Vol. 86, No. 3, pp. 463e468, 2013 Preclinical Evaluation of Genexol®-PM, a Nanoparticle Formulation of Paclitaxel, as a Novel Radiosensitizer for the Treatment of Non-Small Cell Lung Cancer
Invest New Drugs (2012) 30:1984–1990 Phase II study of a cremophor-free, polymeric micelle formulation of paclitaxel for patients with advanced urothelial cancer previously treated with gemcitabine and platinum
EJSO 36 (2010) Abstract No. 456 Determination of maximum-tolerated dose (MTD) of Genexol®-PM (GPM), estimation of efficacy and safety of GPM in aggregate with Gemcitabine treatment in patients with advanced pancreatic cancer
J Breast Cacner 2010 March; 13(1): 104-10 Cost-effectiveness of Genexol®-PM for treating metastatic breast cancer
2014 San Antonio Breast Cancer Symposium Abstract No. P3-10-04 A open-label, randomized, parallel, phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® (conventional paclitaxel with cremorphor EL) in recurrent or metastatic breast cancer patients
Clinical Lung Cancer, Vol. 14, No. 3, 275-82 Paclitaxel-Loaded Polymeric Micelle (230 mg/m2) and Cisplatin (60 mg/m2) vs. Paclitaxel (175 mg/m2) and Cisplatin (60 mg/m2) in Advanced Non–Small-Cell Lung Cancer: A Multicenter Randomized Phase IIB Trial
Cancer Res April 15, 2013 73; 4659 / AACR 104th Annual Meeting 2013; Apr 6-10, 2013; Washington, DC Phase Ⅱ study of a weekly liposomal paclitaxel formulation (Genexol®-PM) and gemcitabine combination chemotherapy in patients with advanced biliary cancer
J Thorac Oncol. 2015
Dec;10(12):1800-6.
A Prospective Phase Ⅱ Study of Cisplatin and Cremophor EL-Free Paclitaxel (Genexol®-PM) in Patients with Unresectable Thymic Epithelial Tumors.
J Clin Oncol 31, 2013 (suppl; abstr 5568) An open label, randomized, parallel, phase Ⅱ trial to evaluate the efficacy and safety of cremophor-free, polymeric micelle formulation of paclitaxel compared to paclitaxel in subjects with ovarian cancer.
Journal of Gynecologic Oncology, 2017 Mar; 28(2):e26 An open-label, multicenter, phase I trial of a cremophor-free, polymeric micelle formulation of paclitaxel combined with carboplatin as a first-line treatment for advanced ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3016)
The Korean Cancer Association (Manuscript ID: CRT-16-376, 2017) An open-label, randomized, parallel, phase II trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3021)
ASCO 2017 (Abstract Number for Publication: 1082) A phase II, multicenter, randomized trial of eribulin plus gemcitabine (EG) vs. paclitaxel plus gemcitabine (PG) in patients with HER2-negative metastatic breast cancer (MBC) as first-line chemotherapy (KCSG BR13-11, NCT02263495)
IIT ongoing study A phase II study of Genexol®-PM and cisplatin as induction chemotherapy in unresectable, locally advanced head and neck squamous cell carcinoma (HNSCC)
A phase II trial of Doxorubicin and Genexol®-PM in patients with advanced breast cancer
Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial
Phase Ⅱ Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects with Recurrent and Metastatic Adenocarcinoma of the Pancreas
A Phase II Study of Weekly Genexol®-PM in Patients With Hepatocelluar Carcinoma After Failure of Sorafenib