On December 9, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO) and Eisai Inc. reported that they will present a scientific poster entitled, "Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN) in Triple Negative Breast Cancer Xenografts" at the 38th Annual San Antonio Breast Cancer Symposium (SABCS) on Dec. 9 (Press release, Halozyme, DEC 9, 2015, View Source [SID:1234508517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The research showed the potential impact for PEGPH20-mediated hyaluronan (HA) removal on concentrations of eribulin and antitumor effects of breast cancer therapy in preclinical models. Halozyme’s investigational new candidate drug, PEGPH20 targets the degradation of HA, a glycosaminoglycan or chain of natural sugars that may accumulate in certain tumors.

Halozyme, a biotechnology company developing novel oncology and drug-delivery therapies, and Eisai Co., Ltd., the parent company of Eisai Inc., announced a clinical collaboration in July 2015, with plans to initiate a phase 1b/2 clinical trial to evaluate PEGPH20 plus eribulin in first-line HER2-negative metastatic breast cancer patients with high-HA tumors.

"Our preclinical studies have revealed important data about the potential for PEGPH20 when used in combination of eribulin, and we are looking forward to expanding on these important preclinical findings when we initiate our clinical study with Eisai," said Dr. Helen Torley, president and CEO of Halozyme. "We remain encouraged by the potential for PEGPH20 to help patients across a range of cancer and therapy types. Our presentation today reflects the growing body of research supporting this potential of PEGPH20."

"Data presented today highlight a productive preclinical collaboration with Halozyme and support Eisai’s commitment to address the unmet medical needs of patients with advanced breast cancer," said Alton Kremer, Deputy President, Oncology PCU and Chief Medical Officer, Global Oncology Business Unit, Eisai Inc. "We are encouraged by these preclinical data and look forward to enrolling patients in the clinical trial early next year."

SABCS Poster Presentation Details:

Poster Session:
P1-03-09, Wednesday, Dec. 9, 5:00 p.m. CT

About Eribulin Mesylate Injection (Available as HALAVEN in the United States)
The above publication does not necessarily contain information that is consistent with the U.S. prescribing information for HALAVEN (eribulin mesylate). It is an investigational use and there is no guarantee that this use will become available commercially.

HALAVEN (eribulin mesylate) injection is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Based on in vitro studies, eribulin exerts its effect via a tubulin-based antimitotic mechanism ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.

Important Safety Information
Neutropenia

Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days

Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels

Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received eribulin. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy

Patients should be monitored closely for signs of peripheral motor and sensory neuropathy
Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received eribulin. Delay administration of eribulin until resolution to Grade 2 or less
Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days)
Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation

Pregnancy Category D

Eribulin is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks
QT Prolongation

In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities
Correct hypokalemia or hypomagnesemia prior to initiating eribulin and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment

For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions

Most common adverse reactions (>25%) reported in patients receiving eribulin were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%)
The most common serious adverse reactions reported in patients receiving eribulin were febrile neutropenia (4%) and neutropenia (2%)

For more information about HALAVEN, click here for the full Prescribing Information.