November 23, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SEATTLE – Following the death of two leukemia patients, Juno Therapeutics has placed a Phase II clinical trial of JCAR015 on hold. This is the second time in less than six months the company halted this trial.
Both patients suffered cerebral edemas, but as of now, Juno has not disclosed what could have led to the swelling in the brain. In July, three patients died from cerebral edemas, which were later related to the addition of the chemotherapy drug, fludarabine.
This morning, Juno once again placed the Rocket trial on hold voluntarily. The trial included adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. Juno said it has notified the U.S. Food and Drug Administration about its decision to place the trial on voluntary hold and is awaiting instructions on how to proceed. Juno said it is assessing data from the deaths and the trial and is evaluating its options regarding the JCAR015 program. JCAR015 is a CAR-T therapy.
In a conference call this morning, Juno said the company could continue the trial, but under modified conditions or could terminate the trial. Juno said preliminary data indicates that the company believes there is a path forward with JCAR015 and plans to release additional data in the coming weeks.
As a result of the announcement, shares of Juno stock plunged more than 44 percent in premarket trading, falling to $16.55 from Tuesday’s close of $29.88 per share.
This is the second time leukemia patients undergoing JCAR015 treatment have died in a clinical trial. In July, the company announced that three patients in the Rocket trial died, which caused a setback for the company. BioSpace previously reported the first patient had received not only JCAR015, but also fludarabine. The other two patients had also received that chemotherapy drug as part of treatment protocol. All three patients died from cerebral edema, which is swelling in the brain caused by excess fluid.
The trial was allowed to resume, but had a revised protocol, only allowing the enrollment of patients with cyclophosphamide pre-conditioning only.
The July deaths sparked a class action lawsuit that alleges the company violated federal securities law. The lawsuit alleges that Hans Bishop, Juno’s chief executive officer, and the company, did not inform investors of a patient death in a Phase II trial of its lead drug.
Juno’s trials and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected, the company said this morning. However, during the conference call, investors expressed concern that some of the toxicity questions around JCAR015 could arise with JCAR017 trials.
Not only has Juno’s stock plunged this morning, but rival CAR-T therapy company Kite Pharma is also down today. Shares of Kite are down nearly 4 percent. Kite believes its interim data of the Phase II trial released in September will be strong enough to lead regulators at the FDA to ultimately give its approval – making KTE-C19 the first CAR-T therapy to reach the market ahead of rivals Juno and Novartis . Kite said it plans to seek regulatory approval of KTE-C19 in diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL), based upon the combined data of multiple trial cohorts. Kite anticipates commercial launch of KTE-C19 in 2017.
