Celgene Corporation (NASDAQ:CELG) announced it has fulfilled the accelerated approval requirements for POMALYST® (pomalidomide) based on results from MM-003, an international phase III study of POMALYST plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma patients. POMALYST, in combination with dexamethasone is approved for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
“There remains a significant unmet need for relapsed/refractory multiple myeloma patients. POMALYST has been able to help thousands of patients since its approval in 2013 and this data now confirms its survival benefits,” said Jacqualyn A. Fouse, Ph.D., President, Global Hematology and Oncology for Celgene. “This label update provides important information about a key product in our industry-leading portfolio of therapies for patients with multiple myeloma.”
In the MM-003 study, median progression-free survival (PFS), the primary endpoint of the study, was significantly longer with POMALYST plus low-dose dexamethasone (3.6 months) than high-dose dexamethasone (1.8 months: HR 0.45 two-sided 95% CI: 0.35-0.59 p < 0.001). Patients in the POMALYST plus low-dexamethasone arm had a 55% reduction in the risk of progression or death.
The pre-specified, final analysis for overall survival (OS) showed a median OS for the POMALYST plus low-dose dexamethasone arm of 12.4 months (95% CI: 10.4, 15.3), compared to the high-dose dexamethasone arm of 8 months (95% CI: 6.9, 9.0). This survival benefit was statistically significant (HR 0.70 [two-sided 95% CI: 0.54, 0.92], p=0.009) even though 53% of patients in the high-dose dexamethasone arm had subsequently received POMALYST. The hazard ratio of 0.70 equated to a 30% reduction in the risk of death for patients receiving POMALYST plus low-dose dexamethasone. Median PFS and OS were based on the assessment of an Independent Review Adjudication Committee.
POMALYST was initially approved by the FDA in February 2013 under the agency’s accelerated approval program based on the phase II study, MM-002. (Original Source)
Shares of Celgene Corporation closed today at $116.09, up $0.55 or 0.48%. CELG has a 1-year high of $129.06 and a 1-year low of $68.38. The stock’s 50-day moving average is $117.97 and its 200-day moving average is $113.03.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on March 31, Citigroup analyst Yaron Werber maintained a Buy rating on CELG, with a price target of $143, which represents a potential upside of 23.2% from where the stock is currently trading. Separately, on March 25, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $156.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yaron Werber and John Newman have a total average return of 27.9% and 14.0% respectively. Werber has a success rate of 79.7% and is ranked #75 out of 3577 analysts, while Newman has a success rate of 60.5% and is ranked #315.
The street is mostly Bullish on CELG stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommend to Hold the stock. The 12-month average price target assigned to the stock is $150.33, which represents a potential upside of 29.5% from where the stock is currently trading.
Celgene Corp is a biopharmaceutical company. It is engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.