December 18, 2009 / 1:31 PM / 10 years ago

UPDATE 3-Celgene's cancer drug Revlimid succeeds in trial

* Celgene’s cancer drug Revlimid meets goal of CALGB trial

* Trial shows Revlimid may work as maintenance therapy

* Celgene shares rise nearly 10 percent

(Updates with analyst comment, updates share price)

By Toni Clarke

BOSTON, Dec 18 (Reuters) - Celgene Corp (CELG.O) said on Friday that initial results from a clinical trial showed multiple myeloma patients who took its drug Revlimid following a stem cell transplant had a 58 percent reduction in risk of their disease progressing.

The company’s shares rose nearly 10 percent to $55.60 in afternoon trading on Nasdaq.

“We anticipated Revlimid would likely be effective in this setting, but these results come sooner than expected and indicate robust Revlimid benefits,” said Brian Abrahams, an analyst at Oppenheimer & Co. “We believe this news provides important momentum for Celgene entering 2010.”

Revlimid is already approved in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior treatment.

The latest study was led by the Cancer and Leukemia Group B (CALGB). The group’s independent data and safety monitoring board reported the trial had met its main goal of showing a statistically significant improvement in time to disease progression.

As a result, the trial was stopped early.

The study was sponsored by the National Institutes of Health under a clinical trials agreement with Celgene.

The data are important because they add weight to the theory that giving patients Revlimid as a maintenance therapy, either after first receiving other drugs or after receiving a stem cell transplant, could improve outcomes.

Earlier this month, Celgene reported data that showed patients who took Revlimid plus the standard drugs melphalan and prednisone, and followed by Revlimid alone, did better in delaying disease progression than those who took melphalan and prednisone alone.

“This is now a second piece of powerful evidence that Revlimid confers substantial benefit when used as maintenance therapy in multiple myeloma patients,” said Geoffrey Porges, an analyst at Sanford Bernstein.”

If Revlimid can be shown to add benefit as a maintenance therapy and is approved as a first line treatment, it could increase sales from an expected $1.7 billion this year to $3.6 billion by 2013, according to the consensus forecast from Thomson Pharma.

Autologous blood stem cell transplantation is a procedure in which a patient’s own blood stem cells are removed, the patient is then treated with high doses of chemotherapy or radiation or both to kill the cancer and then the blood stem cells are put back into the patient.

A total of 568 patients with multiple myeloma who had received no more than 12 months of prior therapy and no prior transplant were enrolled in the trial. The patients all received a transplant followed by melphalan. After the transplant, patients took either Revlimid or a placebo until their disease progressed.

Among those who received the placebo, half saw their cancer worsen within 778 days, or 25.9 months. By comparison, the median time to progression in the Revlimid group could not be defined because fewer than half the patients had a worsening of their disease at that time.

This represents a 58 percent reduction in the risk of disease progression in the Revlimid group.

Revlimid is a derivative of thalidomide, sold by Celgene as Thalomid. (Reporting by Toni Clarke; editing by Dave Zimmerman and Andre Grenon)

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