Amgen announces top-line results of phase 3 talimogene laherparepvec trial in melanoma

AmgenAmgen (NASDAQ:AMGN) announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR: 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance.

"These are the first Phase 3 results of this novel approach to cancer therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients."

The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.

Among the various types of skin cancer, melanoma is the most aggressive and also the most serious. Although melanoma accounts for less than five percent of skin cancer cases, or 132,000 cases globally each year, melanoma accounts for 75 percent of all skin cancer deaths.

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to work in two important and complementary ways - to cause local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.

Additional safety and efficacy data will be submitted to the American Society of Clinical Oncology (ASCO) for the 2013 Annual Meeting.

Trial Design (NCT00769704)
This trial was a global, randomized, open-label, Phase 3 trial to evaluate the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC or IV melanoma.

Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.

About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue. Talimogene laherparepvec is injected directly into tumor tissue and then replicates until the membrane of the cancer cells rupture, thereby destroying the cells, in a process known as cell lysis. The virus that was contained in these cells is then released locally in the tumor tissue along with GM-CSF, a white blood cell growth factor that the virus is engineered to express. This is intended to lead to the activation of a systemic immune response to kill tumor cells throughout the body.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Most Popular Now

Roche launches imCORE, a global network of cancer …

Roche (SIX: RO, ROG; OTCQX: RHHBY) has launched the global cancer immunotherapy Centers of Research Excellence (imCORE™) Network. This network brings together many of the...

Read more

15th Annual eyeforpharma Philadelphia 2017

20 - 21 April 2017, Philadelphia, USA. It's eyeforpharma Philadelphia's 15th year; already the largest, most senior and most influential forum for commercial pharma exec...

Read more

Merck wins R&D 100 Award for top invention

Merck, a leading science and technology company, received a prestigious R&D 100 Award for its Sanger Arrayed Lentiviral CRISPR Libraries - the first of its kind CRISPR li...

Read more

Benzodiazepine and related drug use increases hip …

The use of benzodiazepines and related drugs increases the risk of hip fracture by 43% in persons with Alzheimer's disease, according to a new study from the University o...

Read more

Among antidementia drugs, memantine is associated …

A recent study from the University of Eastern Finland shows that among users of antidementia drugs, persons using memantine have the highest risk of pneumonia. The use of...

Read more

World of viruses uncovered

A groundbreaking study of the virosphere of the most populous animals - those without backbones such as insects, spiders and worms and that live around our houses - has u...

Read more

Boehringer Ingelheim and China Southeast Universit…

Boehringer Ingelheim and China Southeast University Institute of Life Sciences have announced the start of a joint research project to develop new treatment approaches fo...

Read more

Smart patch releases blood thinners as needed

An interdisciplinary team of researchers has developed a smart patch designed to monitor a patient's blood and release blood-thinning drugs as needed to prevent the occur...

Read more

Novartis acquires Selexys Pharmaceuticals Corporat…

Novartis today announced it has acquired Selexys Pharmaceuticals Corporation, a company specializing in development of therapeutics in certain hematologic and inflammator...

Read more

Novo Nordisk expands programme to reach 20,000 chi…

Today, Novo Nordisk announced a four-year extension of its Changing Diabetes® in Children programme which provides access to diabetes care and free insulin to children wi...

Read more

IBM and Pfizer to accelerate immuno-oncology resea…

IBM (NYSE: IBM) Watson Health and Pfizer Inc. (NYSE: PFE) have announced a collaboration that will utilize IBM Watson for Drug Discovery to help accelerate Pfizer's resea...

Read more

Greater efforts are needed to encourage patients t…

In a review of published studies addressing patients' perceptions and factors influencing their reporting of adverse drug reactions, most patients were not aware of repor...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]