Celgene Reports Positive Data on Tecentriq, Abraxane Study


Celgene Corporation (CELG Free Report) announced positive results from a late-stage study on oncology drug, Abraxane, in combination with Roche’s (RHHBY Free Report) immuno-oncology drug, Tecentriq.

The study was sponsored by Roche. IMpassion130, a phase III multicenter, randomized, double-blind study, is evaluating the efficacy, safety, and pharmacokinetics of Tecentriq in combination with Abraxane compared to placebo in combination with Abraxane, in patients suffering from locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for the disease.

The study met its co-primary endpoint of progression-free survival (PFS), as the results show that Tecentriq and Abraxane significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat (ITT) and PD-L1 positive population as an initial (first-line) treatment. Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.

Results from the study will be presented at an upcoming medical meeting.

Notably, this is the third positive phase III study to demonstrate a clinical benefit with Tecentriq plus Abraxane as part of a treatment regimen. The other studies in the program evaluated the experimental combination in non-small cell lung cancer patients.

Positive data from these studies demonstrate the potential role of Abraxane as a preferred chemotherapy partner for immunotherapy combinations.

We remind investors that Celgene is currently working on the label expansion of drugs like Pomalyst/Imnovid, Abraxane and Otezla among others, which is encouraging. Abraxane is currently in various stages of evaluation for breast, pancreatic and non-small cell lung cancers (NSCLC). The drug maintained its dominant market share in the United States for the indication of pancreatic cancer, first-line advanced NSCLC and metastatic breast cancer, despite competitive pressure in the lung and breast cancer markets.

Label expansion of drugs bode well for Celgene as it makes desperate attempts to revamp its portfolio, given the recent pipeline setbacks. The company suffered a setback in early 2018, when it received Refusal to File letter from the FDA regarding its New Drug Application (“NDA”) for multiple sclerosis candidate, ozanimod.  A late-stage study on its lead cancer drug, Revlimid, in combination with Rituxan failed. Consequently, shares took a hammering.

Shares of Celgene are down 19.9% in the year so far compared to a 2.8% decline for the overall biotech industry.

 

Nevertheless, Celgene has a few promising candidates in its pipeline, which should boost prospects.

Celgene acquired Juno Therapeutics and added JCAR017 (lisocabtagene maraleucel; liso-cel) to its lymphoma pipeline. JCAR017 is a best-in-class CD19-directed CAR-T candidate, currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma. The candidate is expected to obtain regulatory approval in the United States in 2019 with potential global peak sales of approximately $3 billion. Another promising candidate is bb2121, an experimental anti-B-cell maturation antigen chimeric antigen receptor (CAR) T cell therapy in collaboration with bluebird bio, Inc. (BLUE Free Report) .

Most recently, Celgene and partner Acceleron Pharma Inc. (XLRN Free Report) announced back to back positive results from two late-stage studies on pipeline candidate, luspatercept.

Zacks Rank 

Celgene carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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