Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) announced updated results of its pivotal phase III FIRSTTM (MM-020/IFM 07-01) trial, comparing continuous REVLIMID® (lenalidomide) plus low-dose dexamethasone (continuous Rd) to a fixed duration of 18 cycles of Rd (72 weeks) (Rd18) or 12 cycles of melphalan, prednisone and thalidomide (72 weeks) (MPT) for the treatment of transplant ineligible patients with newly diagnosed multiple myeloma. The results, as part of the Regulatory submissions which led to the REVLIMID® label expansion in the US and EU in February 2015, were presented during the European Hematology Association annual congress.
In the study, the primary endpoint was progression-free survival (PFS) and the primary analysis was between continuous Rd and MPT. Overall survival was a secondary endpoint, along with response rate, duration of response, time to response, safety, time to second-line anti-myeloma treatment and best response achieved to second-line anti-myeloma treatment.
An updated analysis of progression-free survival (PFS) demonstrated a median of 26.0 months for patients treated with continuous Rd compared with 21.9 months for MPT (HR 0.69 (95% CI, 0.59‐0.80) p=0.00031). The median PFS for Rd18 was 21.0 months.
Continuous Rd treatment (doublet regimen) continued to show an OS advantage, with a 25% reduction in risk of death versus the triple-agent MPT regimen in this updated survival analysis (HR 0.75 (95% CI, 0.62‐0.90), translating into a median OS improvement of 10.4 months (from 48.5 to 58.9 months). The median OS for Rd18 was 56.7 months. The median follow up was 45.5 months.
“The updated results of the FIRST study reinforce the survival advantage for continuous REVLIMID therapy in patients newly diagnosed with multiple myeloma,” said Prof. Thierry Facon, MD, University of Lille and primary investigator of the study.
An updated analysis of safety in the continuous Rd arm remained similar with extended follow-up to previously reported data (N Engl J Med 2014). Those data showed that grade 3/4 adverse events that occurred in at least 8% of patients in the continuous Rd arm, Rd18 arm or MPT arm included neutropenia (28%, 26% and 45%, respectively), anemia (18%, 16% and 19%, respectively), thrombocytopenia (8%, 8% and 11%, respectively), febrile neutropenia (1%, 3% and 3%, respectively), leukopenia (5%, 6% and 10%, respectively), infection (29%, 22% and 17%, respectively), pneumonia (8%, 8% and 6%, respectively), deep-vein thrombosis and/or pulmonary embolism (8%, 6% and 5%, respectively), asthenia (8%, 6% and 6%, respectively), fatigue (7%, 9% and 6%, respectively), and peripheral sensory neuropathy (1%, < 1% and 9%, respectively).
An updated analysis of the incidence of invasive second primary malignancies was 3.9% in patients taking continuous Rd, 6.1% in patients taking Rd18 and 5.5% in patients taking MPT. The incidence of solid tumors was similar in the continuous Rd and MPT arms (3.4% and 3.3%, respectively) and 5.9% in the Rd18 arm. (Original Source)
Shares of Celgene Corporation closed yesterday at $112.97 . CELG has a 1-year high of $129.06 and a 1-year low of $79.42. The stock’s 50-day moving average is $113.39 and its 200-day moving average is $116.34.
On the ratings front, Celgene Corporation has been the subject of a number of recent research reports. In a report issued on June 1, J.P. Morgan analyst Cory Kasimov reiterated a Hold rating on CELG. Separately, on the same day, Cowen’s Eric Schmidt reiterated a Buy rating on the stock and has a price target of $146.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Eric Schmidt have a total average return of 15.1% and 61.3% respectively. Kasimov has a success rate of 64.0% and is ranked #189 out of 3623 analysts, while Schmidt has a success rate of 76.0% and is ranked #15.
The street is mostly Bullish on CELG stock. Out of 8 analysts who cover the stock, 6 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $146.00, which implies an upside of 29.2% from current levels.
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.