Juno's ROCKET Study On Clinical Hold Again, Shares Down
Zacks Investment Research | Nov 24, 2016 07:31AM ET
Juno Therapeutics, Inc. (NASDAQ:JUNO) announced that it has voluntarily placed a phase II trial of its lead pipeline candidate, JCAR015 on hold after two patients suffered cerebral edema earlier in the week. One of the patients died and the other has very low chances of recovery.
The ROCKET trial was evaluating patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
Share price of the company plunged more than 24% following the disappointing news.
The company has notified FDA regarding the hold. Juno is working with the agency and the Data and Safety Monitoring Board to decide the next course of action.
Earlier in July, the FDA placed a clinical hold on the same study as two patients had died within a week due to severe neurotoxicity after the addition of fludarabine to the pre-conditioning regimen. The FDA had asked the company to submit, as a complete response to the clinical hold, a revised patient informed consent form, a revised investigator brochure, a revised study protocol, and a copy of the presentation made to the agency.
Later in the month, the FDA lifted the clinical hold on the study and it continued under a revised protocol using JCAR015 with cyclophosphamide pre-conditioning alone.
Juno was earlier looking to gain accelerated FDA approval of JCAR015 in 2017 but timelines were pushed back with the announcement of the clinical hold in July to the first half of 2018. However, now that the study is again on hold, the regulatory filing timeline could be shifted further.
Per the company’s press release, its studies and plans for its other CD19-directed CAR T cell pipeline candidates, with JCAR017, have not been affected.
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