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Celgene Doesn't Want To Be Left Out, Posts Promising JCAR017 Data

Dec. 06, 2018 7:46 PM ETCelgene Corporation (CELG)GILD, NVS11 Comments


  • Celgene announces positive preliminary data from its study treating patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) using JCAR017.
  • A key risk is whether or not hospitals and insurers will pay the hefty price tag of CAR-T therapies, which may impact sales.
  • Of the 81% of patients that got an ORR who were treated with JCAR017, 43% achieved a complete response.
  • It is estimated that the global CAR-T cell therapy market could be worth $8 billion by 2028.
  • Competition is strong in the lymphoma space using CAR-T. Such companies are, for instance, Novartis with Kymriah and Gilead Sciences with Yescarta.
  • Looking for a portfolio of ideas like this one? Members of Biotech Analysis Central get exclusive access to our model portfolio. Start your free trial today »

Recently, Celgene (NASDAQ:CELG) announced preliminary data from its study treating patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The data shown was from the dose escalation part of an ongoing, open-label multicenter phase 1/2 study using JCAR017 to treat these patients. I think that the preliminary data is strong, especially when you consider that a large chunk of this population were given prior treatment with ibrutinib and had cytogenetic features of high-risk disease. This data is preliminary, but it is quite strong.

Phase 1/2 Monotherapy Data

The phase 1 portion of this program, known as TRANSCEND CLL-004, explored the monotherapy dose-escalation part of the main study. This study data included about 16 patients with at least a median of 4.5 lines of prior therapy. First of all, that is a lot of prior therapy attempts to get a patient to generate a response. Think about that, all these patients had gone through 4 or more therapies with no success. In addition, patients had high-risk cytogenetic features. In essence, cytogenetic features meaning erratic behavior of cells and how they divide. The problem with patients that have cytogenetic features are that they tend to respond differently depending upon what treatment they are given.

The final thing to note is that patients recruited into the study had already received and not responded to ibrutinib (Imbruvica) treatment. Imbruvica is a strong drug, but sometimes it may not generate a response for some patients in this refractory population. To showcase this item, it is important to look at what patients had taken as prior treatment with Imbruvica. At least 81% of the patients recruited had relapse/refractory disease on Imbruvica. It was also known that 50% of patients had received prior therapy with both Imbruvica and Venclexta (venetoclax). Having said all that, those treated with JCAR017 obtained an overall response rate (ORR) of 81%. Even more impressive

This article was written by

Terry Chrisomalis profile picture
Actionable ideas on small-large cap biotech stocks through deep analysis.

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