Bristol-Myers Squibb ($BMY) and Celgene ($CELG) are joining forces on a cancer combination treatment, testing the former's highly anticipated immunotherapy in tandem with an on-the-market chemo drug against a host of tumor targets.
The plan is to launch a Phase I study pairing Bristol-Myers' nivolumab, a cancer treatment designed to bring about the death of tumor cells by blocking a pathway called PD-1; and Celgene's Abraxane, an injectable form of the chemotherapy paclitaxel already approved to treat pancreatic, prostate, breast and lung cancers.
The hope is that combining nivolumab's effect on the immune system with Abraxane's ability to halt cancer cell division will result in a therapy greater than the sum of its parts, the companies said, and they plan to kick off their trial in the fourth quarter of this year. Among their targets are HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer.
For Celgene, the study is an opportunity to cut in on the expected multibillion-dollar market expected to come about as PD-1 therapies win approvals around the globe. If Abraxane can bolster the effects of nivolumab, the Big Biotech can hitch its fast-growing cancer treatment to what could be a meteoric launch for Bristol-Myers' contender, which is expected to bring in about $6 billion a year by 2020. (Celgene's treatment has made headway of its own since winning a pancreatic approval last year, growing 39% year-over-year to bring in $215 million in the second quarter.)
The partnership fits right in with Bristol-Myers sweeping development effort for its star oncology candidate, spending big on combination studies and monotherapy trials as it races to cash in on the promise for treatments targeting the lock-and-key proteins PD-1 and PD-L1.
At stake is the largest share of a PD-1 market projected to peak as high as $35 billion a year, and Bristol-Myers is contending with Merck ($MRK), AstraZeneca ($AZN), Roche ($RHHBY) and others with plans to string together FDA approvals and capitalize on stellar data for the whole class. Each contender has mounted a similarly expansive--and expensive--development strategy, mixing and matching immunotherapies in an effort to identify the most promising combinations.
And while Merck is almost certain to hit the U.S. market first with its pembrolizumab, nivolumab became the first PD-1 inhibitor approved anywhere in the world when it picked up a Japanese nod last month. Bristol-Myers plans to submit an FDA application for the drug next quarter, targeting melanoma first as it works through late-stage studies in other cancers. If approved, the drug will trade as Opdivo.
- read the statement
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