Juno Reports Additional Data On CAR-T Therapy, Shares Drop
Zacks Investment Research | Dec 12, 2017 05:52AM ET
Juno Therapeutics, Inc. (NASDAQ:JUNO) along with partner Celgene Corporation (NASDAQ:CELG) announced additional data from a phase I study (TRANSCEND) on its lead pipeline candidate, JCAR017 (lisocabtagene maraleucel), for treatment of patients with relapsed or refractory (r/r) aggressive non-Hodgkin lymphoma (“NHL”). Results were presented at the 59th annual meeting of American Society of Hematology.
Notably, JCAR017 is a next-generation chimeric antigen receptor and high-affinity T cell (CAR-T) receptor product that targets CD19.
The company presented separate data from the TRANSCEND study for the full group of patients enrolled as well as the core group i.e. a high-risk patient population.
Finds from the multi-center TRANSCEND trial demonstrated that at dose level 2, 74% of patients with the aforementioned indication showed an overall response rate (ORR) and 68% complete response (“CR”) rate at three months in core group. Additionally, 50% of patients showed CR at six months.
These figures are better than the previous data of 66% ORR and 50% CR reported in June. Moreover, the safety profile of JCAR017 remains impressive with only 1% of patients experiencing severe cytokine release syndrome and 15% experiencing severe neurotoxicity.
It is interesting to note that Juno’s shares dropped almost 15% following the news release probably as investors expected better response rates. However, shares of Juno have significantly gained 166.5% of its value so far this year, comparing favorably with the industry ’s increase of 3%.
Good news is that the safety and efficacy outcomes showed better overall and complete responses compared with Gilead's (NASDAQ:GILD) Yescarta and Novartis' (NYSE:NVS) Kymriah CART therapy, which have recently launched in the United States.
The company plans to bring JCAR017 to the market for NHL by the end of 2018 with a biologics license application expected to be filed in the second half of 2018.
We note that, bluebird bio also announced five months of follow-up data from the ongoing phase I study of its CAR-T therapy candidate- bb2121. The study is evaluating the preliminary safety and efficacy of bb2121 in patients with relapsed and/or refractory multiple myeloma. Of the 18 patients in the active dose cohorts of the study, 94% achieved an objective response (OR). 56% patients achieved a complete response compared with the CR rate of 27% as shown in the data released at ASCO in June this year.
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