Phase III Study of Investigational Compound Ipilimumab Achieves Primary Endpoint

Bristol-Myers SquibbBristol-Myers Squibb Company (NYSE: BMY) today announced that a clinical trial - known as study 024 - of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma. Study 024 was designed to assess overall survival in unresectable stage III or stage IV melanoma patients who have not received prior therapy. The study compares ipilimumab 10mg/kg in combination with chemotherapy (dacarbazine) vs. chemotherapy alone. An abstract of the 024 data will be submitted to the American Society of Clinical Oncology for potential presentation at the Annual Meeting in June of this year.

A regulatory filing for ipilimumab, based on a study known as 020, is currently under review by the U.S. Food and Drug Administration and other health authorities worldwide. The filings are based on study 020, which assessed overall survival in previously-treated unresectable stage III or stage IV melanoma patients. Study 020 compared ipilimumab 3 mg/kg + gp100 vaccine vs. gp100 vaccine alone and ipilimumab alone vs. gp100 vaccine alone. The PDUFA date for the U.S. filing is March 26, 2011.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Most Popular Now

GSK reaches agreement with Novartis to acquire ful…

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has reached an agreement with Novartis for the buyout of Novartis' 36.5% stake in their Consumer Healthcare Jo...

Canadian neuroscientists say daily ibuprofen can p…

A Vancouver-based research team led by Canada's most cited neuroscientist, Dr. Patrick McGeer, has successfully carried out studies suggesting that, if started early enou...

First proof a synthesized antibiotic is capable of…

A "game changing" new antibiotic which is capable of killing superbugs has been successfully synthesised and used to treat an infection for the first time - and could lea...

Merck partners with Medisafe to help improve medic…

Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication ...

Novartis teams up with Harvard to develop next gen…

Novartis announced today that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Can...

Phase III data in The Lancet show Novartis siponim…

Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) w...

Taking a standard prostate cancer drug with food b…

By taking a high-cost drug with a low-fat meal - instead of on an empty stomach, as prescribed - prostate cancer patients could decrease their daily dose, prevent digesti...

North and south cooperation to combat tuberculosis

Tuberculosis can be cured and could be eradicated. For this to happen, however, patients have to receive the right treatment. Researchers at the Makerere University and t...

New immunotherapy for lung cancer shows promise of…

In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at contro...

Lokelma approved in the EU for the treatment of ad…

AstraZeneca today announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment...

New targeted therapy schedule could keep melanoma …

Skin melanoma, a particularly insidious cancer, accounts for the vast majority skin cancer deaths and is one of the most common cancers in people under 30. Treatment for ...

Personalized tumor vaccine shows promise in pilot …

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and...