Kite, analysts unfazed by Juno trial issues, say low-dose fludarabine safe

Lab work

Kite Pharma ($KITE) has said it has no concerns with its recently enrolled experimental CAR-T trial that is using a chemo drug now dropped by rival Juno ($JUNO) after it associated a high-dose form of the treatment with four deaths.

The drug under question, the chemotherapy agent fludarabine, has been identified by Juno and the FDA as being the likely factor in four reported deaths--due to cerebral edema--coming out of Juno’s tests this year.

A Phase II blood cancer trial using fludarabine and cyclophosphamide as preconditioning agents with its CAR-T candidate was briefly halted late last week, only for the FDA to allow it to continue a few days later.

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But the trial can now only go ahead without the use of fludarabine (aka Flu), but will continue to use cyclophosphamide, with both the FDA and Juno seemingly happy that the use of Flu--which the biotech said was only recently added to the ROCKET study--was the only culprit.

A few hours after the shock announcement from Juno last week, Kite released a statement saying it had just finished enrolling 72 patients in its Phase II portion of its ZUMA-1 CAR-T trial in certain blood cancer patients.

This trial will also be using both cyclophosphamide and fludarabine as preconditioning agents (used three days before infusion of its candidate KTE-C19)--although it said these would both be at a “low dose,” and much lower than that used in the Juno trial.

The company tells FierceBiotech that it has no concerns over the use of the drug in its study.

A spokesman for the company said: “Kite Pharma’s announcement regarding the enrollment of the 72nd patient marks a significant milestone in our ZUMA 1 trial. This trial is the culmination of over 10 years of study and testing where Kite and our NCI collaborators have carefully examined every aspect of CAR-T therapy including the optimal dose pre-conditioning regimen of cyclophosphamide and fludarabine and the KTE-C19 cell dose. 

“Our analysis has been methodical and systematic and included dose ranging studies and a Phase I run-in to the ZUMA studies of DLBCL and ALL. Kite’s clinical program is ongoing with data anticipated from the ZUMA 1 trial later this year.”

Juno itself has been found to have released some inaccurate information, according to analysts at Jefferies, who in a note to clients say that there have now been four confirmed deaths from cerebral edema, as opposed to the three first reported last week.

The note added: “Critically, we also know that a flu/cy regimen much higher than what Kite uses in their trials (roughly 4 times more of cy for ALL pts) was involved in all 4 cerebral edema cases.”

Jefferies said that given the new information that the deaths were linked to Juno's much higher dose of flu/cy, “We view this disclosure as limiting read-through to Kite even further as all 4 deaths involved a high dose of flu/cy.”

Juno’s shares were hit the hardest in the fallout from the halted trial last week but rebounded after the FDA allowed its altered study to restart.  

Kite also saw its shares hit, but not by as much, and closed yesterday at more than 3% up. Juno was in fact up by nearly 9.5% at close.

- read Juno’s new 8-K SEC form

Related Articles:
Hours after Juno CAR-T study deaths announced, Kite enrols CAR-T PhII
FDA clears Juno to resume CAR-T trial

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