Celgene Surprises With Melanoma Drug Study Victory

SUMMIT, NJ (TheStreet) --Celgene (CELG) said Tuesday that a late-stage study of its cancer drug Abraxane met its primary endpoint of delaying the growth of tumors in patients with advanced melanoma.

The impact of the positive results from the phase III study is unclear at this time, however, because Celgene did not say if patients treated with Abraxane lived longer. New therapies for melanoma such as Bristol-Myers Squibb's (BMY) Yervoy and Roche's (RHHBY) Zelboraf were both approved on the basis of improving overall survival.

Celgene shares were up $1.22, or 1.5%, to $78 in early Tuesday trading.

The phase III study enrolled patients with metastatic melanoma who had no previous treatment with chemotherapy. The patients were randomized to receive treatment with Abraxane, a reformulation of the old chemotherapy drug paclitaxel, or DTIC, another older chemotherapy often used to treat melanoma.

Patients treated with Abraxane lived longer without their melanoma progressing compared to patients treated with CTIC, Celegene said. The result was statistically significant although details were withheld for presentation at a later medical meeting.

The study was designed to measure if Abraxane could improve overall survival compared to DTIC but these data may not be ready yet.

Abraxane is already approved to treat advanced breast cancer and is under FDA review for non-small cell lung cancer with an expected approval decision on Oct. 12.

Celgene is also conducting a phase III study of Abraxane in pancreatic cancer with results expected later this quarter. The pancreatic cancer study was the subject of much positive chatter at a cancer research conference in Europe this weekend.

The value of Abraxane is also tied to a publicly traded Celgene contingent value (CELGZ) right established when Celgene bought the drug's inventor Abraxis BioScience in 2010.

-- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein

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