Market Overview

Celgene Reports Phase III Study of Oral REVLIMID® in Newly-Diagnosed Multiple Myeloma Meets Primary Endpoint

Share:
Related CELG
ABRAXANE Approved by European Commission for First-Line Treatment of Patients with Non-Small Cell Lung Cancer
Mike Khouw's Celgene Trade
Stock Market News for March 05, 2015 - Market News (Zacks)

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID^® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).

One of the largest phase III randomized, international studies ever conducted in newly-diagnosed multiple myeloma, MM-020/IFM 07-01 is also known as the FIRST^® (Front-Line Investigation of REVLIMID/Dexamethasone vs. Standard Thalidomide) trial. The international study randomized 1,623 patients who were ineligible for autologous stem cell transplantation to receive continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone and thalidomide for up to twelve 42-day cycles (72 weeks).

The primary endpoint for the study was PFS. Secondary endpoints include overall survival, response rate, quality of life and safety.

The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study are planned to be presented at an upcoming medical meeting.

Based on the results of the FIRST^® study, the Company will commence discussions with regulatory authorities and plans to submit dossiers for registration in the US, Europe and other markets.

These results are from an investigational phase III study. REVLIMID is not approved for the treatment of patients with newly-diagnosed multiple myeloma in any country.

Posted-In: News FDA

 

Related Articles (CELG)

Around the Web, We're Loving...

Get Benzinga's Newsletters

Our Experts vs. S&P 500Powered by Benzinga
Marketfy Products Return S&P 500
Morning Profit Maker 42.72% 6.69%
The Option Prophet 91.14% 6.69%
SecretCaps 26.55% 6.69%
Short-Term Trend Trading 11.89% 6.69%
View the highest rated products→