Celgene Corporation (CELG - Free Report) announced encouraging results from an interim analysis of a phase IIIb study, MAGNIFY, on Revlimid.
The study evaluated Revlimid in combination with Roche Holding AG’s (RHHBY - Free Report) Rituxan (R2) in patients with relapsed or refractory marginal zone lymphoma (MZL). The results were presented at nternational Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
The study continues to show promising results and tolerable safety profile in indolent lymphomas particularly in difficult-to-treat patient subsets.
Shares of Celgene have outperformed the Zacks classified Medical-Biomedical and Genetics industry year to date. Specifically, the stock gained 5.8% during this period, compared with a gain of 2% for the industry.
Celegene’s key growth driver, Revlimid is an oral immunomodulatory drug ad is currently approved for several indications including multiple myeloma (MM), myelodysplastic syndromes (MDS) and mantle cell lymphoma (MCL).
The MAGNIFY study evaluates the clinical activity of 12 cycles of R2 combination therapy followed by randomization to either 18 cycles of R2 maintenance or 18 cycles of Rituxan monotherapy, in patients with relapsed or refractory follicular lymphoma (FL), MZL or MCL. The primary endpoint in the study is progression-free survival (PFS). As of Jan 9, 2017, the PFS for all FL patients was 70%, and evaluable FL patients had overall response rate (ORR) of 66% which was the secondary endpoint.
Data at IMCL also focused on patients with MZL. After 13.8 months of initiation of therapy with the R2 combination, evaluable patients with MZL (n=32) achieved an ORR of 66%.
The most common grade 3 or 4 adverse events observed in patients with MZL were neutropenia (32%), thrombocytopenia (16%) and leukopenia (11%).
REVLIMID was granted Orphan Drug Designation for the treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue in April 2015.
Currently, Celgene is working on expanding Revlimid’s label further. Revlimid received FDA approval for use as a maintenance treatment in NDMM patients after they receive an autologous stem-cell transplant. The drug was also approved in the EU for the same. NDMM market share continues to grow outside of the U.S., with a positive uptake both in the EU and in Japan. A label expansion of the drug is expected to boost sales further.
Zacks Rank & Stocks to Consider
Celgene currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. (VVUS - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with average beat of 66.56%. The share price of the company increased 39.6% year to date.
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