Abraxane Wins Nod in Pancreatic Cancer
By Jennifer Boggs
The FDA approved Celgene Corp.’s Abraxane Friday for use in pancreatic adenocarcinoma. It’s the first drug approved for patients with metastatic pancreatic cancer in nearly eight years, and analysts are expecting the combination of the albumin-bound version of paclitaxel and gemcitabine to become the new standard of care in what has remained an intractable disease.
Abraxane’s nod came two weeks ahead of the Sept. 21 PDUFA date and was based on data from the 861-patient Phase III MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), which showed that Abraxane plus gemcitabine demonstrated statistically significant improvement in median overall survival vs. gemcitabine alone (8.5 months vs. 6.7 months, p < 0.0001). That boiled down to a 28 percent overall reduction in the risk of death. (See BioWorld Today, Jan. 24, 2013.)
Combination treatment also bested gemcitabine alone in progression-free survival (5.5 months vs. 3.7 months, p < 0.0001) and demonstrated an overall response rate of 23 percent vs. 7 percent in the gemcitabine-only arm (p < 0.0001).
While those data are perhaps modest compared to results from other cancer drug trials, they provided a much-needed win in a space riddled with failures in the past decade. Johnson & Johnson’s farnesyl transferase inhibitor tipifarnib and Vernalis plc forerunner British Biotech LLP’s matrix metalloproteinase inhibitor marimastat both imploded in Phase III pancreatic cancer studies, while Phase II fizzles have included Infinity Pharmaceuticals Inc.’s hedgehog drug saridegib and CO-101 from partners Clavis Pharma ASA and Clovis Oncology Inc. The CO-101 had been particularly disappointing, given that the drug was a modified version of gemcitabine designed to improve uptake and retention. (See BioWorld Today, Jan. 30, 2012, and Nov. 13, 2012.)
Prior to Abraxane, only FOLFIRINOX, a cocktail of chemo drugs oxaliplatin, irinotecan, fluorouracil and leucovorin, had proved more effective than gemcitabine alone. But its toxicity precludes physicians from using FOLFIRINOX in the majority of advanced pancreatic cancer patients. (See BioWorld Insight, Feb. 19, 2013.)
“For more than 15 years, treatment with gemcitabine has been the standard of care in this disease,” noted Jean-Pierre Bizzari, executive vice president of hematology and oncology at Summit, N.J.-based Celgene. “The addition of Abraxane to gemcitabine demonstrated meaningful improvements across key efficacy outcomes, including overall survival, with a well-characterized safety profile.”
According to Celgene, the most common adverse reactions seen in the Abraxane/gemcitabine arm of MPACT included neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite and dehydration.
Data were submitted in a supplemental application and, in May, the FDA granted priority review. A marketing authorization application seeking approval of Abraxane plus gemcitabine in first-line patients with metastatic adenocarcinoma of the pancreas is under review in Europe, and Celgene also has submitted dossiers in other regions.
The big biotech picked up rights to Abraxane in its 2010 buyout of Abraxis Bioscience Inc. for $2.9 billion, with the aim of ramping up sales of Abraxane in breast cancer and expanding its use in other indications. Under the terms of that deal, Celgene agreed to pay a $250 million milestone to Abraxis shareholders upon approval of the drug in non-small-cell lung cancer – granted last year – with another $300 million due upon approval in pancreatic cancer. (See BioWorld Today, July 1, 2010.)
For the second quarter, Abraxane sales totaled $155 million, up 41 percent for the same quarter in 2012. And the majority of that sales increase came from the drug’s use in lung cancer rather than pre-approval use in pancreatic cancer, noted Wells Fargo analyst Brian Abrahams. That suggests “considerable room for uptake in this expanded indication,” he wrote in a research note.
Abrahams is predicting about $60 million in Abraxane revenue for pancreatic cancer this year, with the figure growing to more than $500 million by 2017. He estimated total revenues from Abraxane to be about $1.4 billion in 2017.
The next big Abraxane news is expected to be a readout of the overall survival data from the Phase III melanoma trial, expected in the fourth quarter of this year.
Shares of Celgene (NASDAQ:CELG) closed Friday at $146.97, up $1.38.
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