Celgene Corp's cancer drug, Revlimid, significantly extended the lives of patients with multiple myeloma who took the drug as a maintenance therapy following a stem cell transplant.
Data presented at the 2011 International Myeloma Workshop in Paris showed patients who took the drug for an extended period had a slightly greater risk of developing a second primary malignancy (SPM) -- something that pushed the company's shares down 3.1 percent -- but analysts said the overall benefit of the drug exceeds the risk.
Revlimid is already approved to treat multiple myeloma in patients who have failed at least one previous treatment. The company is seeking to show that patients can benefit if they receive treatment earlier and for longer periods.
"The key take-away from all the presenters was that there was no recommendation to discontinue Revlimid at a shorter period, which was feared," said Geoff Meacham, an analyst at J.P. Morgan. "The benefit/risk profile of Revlimid remained very favorable overall according to 100 percent of the key opinion leaders, even in the context of SPMs."
Celgene is hoping to win approval to market the drug in Europe and, later, in the United States, as a first-line treatment and for longer periods of time. Investors had been concerned an increase in second primary malignancies (SPMs) could cause regulators to deny or delay approval.
Analysts doubt that will be the case.
"Overall, I remain convinced that the totality of the data will likely support EU approval of maintenance Revlimid in early 2012, despite the increased rate of SPMs," Mark Schoenebaum, an analyst at ISI group, said in a research note.
Data from a late-stage trial led by the Cancer and Leukemia Group B (CALGB) showed newly diagnosed patients who received a stem cell transplant followed by continuous treatment with Revlimid had a 56 percent reduction in the risk of disease progression or death compared with those taking a placebo.
Alongside that survival benefit, was data from a trial known as MM-015 that showed an increase in SPMs. In the trial, one group of patients took Revlimid in combination with the standard treatments melphalan and prednisone (MPR) for nine cycles. Another group took MPR and followed that with Revlimid alone (MPR-R). Another group took MP alone.
Updated data showed that the number of SPMs had increased to 12 in the MPR-R arm, up from four previously, and was nine for the MPR arm, up from six previously. There were four SPMs in the MP arm, up from two previously, he said.
Brian Abrahams, an analyst at Wells Fargo, said in a research note the data suggests that with longer follow-up, the SPM risk is highest with Revlimid maintenance.
However, he said: "The totality of data validates that Revlimid confers important survival benefits and can be used reasonably safely for a finite dosing period in the post-transplant maintenance setting, and acceptably safely in front-line."
Data from the CALGB trial showed that, while the rate of SPMs was higher, there was no apparent impact on the rate of overall survival or on time to disease progression.
After roughly 28 months, 90 percent of patients in the Revlimid arm of the trial were alive, compared with 83 percent of those in the placebo arm.
The average time before the disease progressed in patients in the CALGB trial who took Revlimid was 48 months, compared with 30.9 months in the placebo arm. This translated into a 56 percent reduction in the risk of disease progression compared with patients taking a placebo.
The average rate of event-free survival, meaning survival without progression of the disease, secondary primary malignancies or other serious events, was 43.4 months in the Revlimid arm compared with 30.9 months in the placebo arm.
In the CALGB trial, patients were given a high dose of melphalan, a stem cell transplant followed by Revlimid, or were given melphalan, a stem cell transplant and a placebo.
Data presented in December showed that patients in the Revlimid group had a 60 percent reduction in the risk of their disease progressing after four years. You can read more about Soma Drugs Without Prescription