Bristol's breakthrough melanoma drug delivers promising data in Ph3

With key analysts predicting regulatory approval later in the week for Bristol-Myers Squibb's ($BMS) ipilimumab--a breakthrough immunotherapy cancer treatment--researchers delivered a fresh batch of promising late-stage data on the melanoma drug.

In Phase III the drug hit its primary endpoint for extending overall survival among previously untreated patients with advanced melanoma. The company is holding back details on the data for a later scientific meeting, but the fresh proof of efficacy is being added to outcomes in a separate study of previously treated patients, who gained an extra four months survival time from the therapy.

"Ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer," noted Sanford Bernstein analyst Tim Anderson.

Ipilimumab is designed to whip up an immune system attack on cancer cells, a new approach to stopping cancer with potential to fight an array of tumor types. "It's not a stretch to say this would be a multi-billion dollar class," Seamus Fernandez with Leerink Swann tells Bloomberg, if the drug can also prove efficacy against more common cases like prostate and lung cancers. "Bristol is way ahead of everyone on the immunotherapy front."

An approval here could poise BMS for a banner year. The developer has several PDUFA dates ahead, offering key product advances at a time some bigger companies have been struggling to get drugs through the clinic. Bristol acquired ipilimumab when it bought out Medarex, following a favored path that leads from a partnership to an acquisition.

- see the story from Reuters
- and here's Bloomberg's article on the drug