Juno Therapeutics, Inc. JUNO along with partner Celgene Corporation 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 GILD Yescarta and Novartis' 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.
Juno Therapeutics, Inc. Price
Juno Therapeutics, Inc. Price | Juno Therapeutics, Inc. Quote
Juno carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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