Features | Partner Sites | Information | LinkXpress
Sign In
JIB
GLOBETECH PUBLISHING
BioConferenceLive

New Drug Shown to Reduce Size in Both Injected and Metastasized Melanoma Tumors

By BiotechDaily International staff writers
Posted on 02 Apr 2014
A retrospective analysis of patients with metastatic melanoma revealed that a new pharmaceutical agent was shown to reduce the size of injected tumors and also non-injected tumors that had metastasized to other regions of the body.

The analysis documented tumor-level responses from a pivotal phase 3 study evaluating the agent, called talimogene laherparepvec, in patients with injectable unresected stage IIIB, IIIC, or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). The findings were presented March 14, 2014, at the Society of Surgical Oncology (SSO) 67th annual Cancer Symposium in Phoenix (AZ, USA).

Talimogene laherparepvec, developed by Amgen (Thousand Oaks, CA, USA), is a research oncolytic immunotherapeutic agent designed to selectively replicate in tumor tissue and to initiate a systemic antitumor immune response. Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with the drug at least once, while the rest were not injected, including visceral tumor lesions (tumors involving solid organs such as the lungs and liver). The study’s findings showed a 50% or greater reduction in tumor size in 64% of injected tumors. Furthermore, one-third of uninjected nonvisceral tumors, and 15% of visceral tumors were also reduced by at least 50%. There were 35 melanoma-related surgeries performed during this trial of which 30% successfully removed all residual disease.

The most frequently seen adverse events in the phase 3 study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26% of talimogene laherparepvec patients and 13% of GM-CSF patients. Immune-mediated events were reported infrequently.

“These data add to the body of evidence supporting talimogene laherparepvec’s local and distant effect, and its potential ability to stimulate a systemic antitumor immune response,” said Sean E. Harper, MD, executive vice president of research and development at Amgen. “Melanoma remains a devastating and difficult-to-treat disease, and talimogene laherparepvec continues to demonstrate encouraging results in this setting.”

The agent is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells causing lytic cell death and releasing an array of tumor-derived antigens. Talimogene laherparepvec is also engineered to express granulocyte-macrophage colony-stimulating factor (GM-CSF), a white blood cell growth factor, which can help to activate the immune system. The aim of this combination of actions is to initiate a systemic antitumor immune response that targets tumor cells throughout the body.

Related Links:

Amgen



comments powered by Disqus

Channels

Genomics/Proteomics

view channel
Image: Blocking the activity of HSP101 may imprison the malaria parasite inside its protective vacuole within the red blood cell. In the electron micrograph, the malaria parasites appear in blue and uninfected red blood cells are shown in red (Photo courtesy of the [US] National Institute of Allergy and Infectious Diseases).

Heat Shock Protein Plays Critical Role in Malaria Parasite Protein Trafficking

A pair of recent papers described the molecular operators that enable the malaria parasite Plasmodium falciparum to export a large variety of proteins across the parasitophorous vacuolar membrane (PVM)... Read more

Therapeutics

view channel

Vaccine Being Developed for Heart Disease Close to Reality

The world’s first vaccine for heart disease is becoming a possibility with researchers demonstrating significant arterial plaque reduction in concept testing in mice. Klaus Ley, MD, from the La Jolla Institute for Allergy and Immunology (LA Jolla, CA, USA), and a vascular immunology specialist, is leading the vaccine... Read more

Business

view channel

A Surge in IPOs Revitalize Investments for the Global Pharma and Biotech

Anti-infective drugs, oncology, and pharmaceutical contract laboratories attract the most investment up to now. The intensified private equity and venture capital (PEVC) deal activity in the global healthcare industry during the recession years, 2008–2010, witnessed a waning post-2010. However, the decline in deals... Read more
 
Copyright © 2000-2014 Globetech Media. All rights reserved.