Novartis’ decision to scale back on its CAR-T research has grabbed the headlines in recent months, but biotech Juno, itself the subject of major headlines over the summer when safety concerns briefly halted one of its studies, is looking to its recent data as a positive for the field.
In a paper published this week by Juno ($JUNO) in Science Translational Medicine, the Seattle-based biotech said its CAR-T candidate JCAR014, along with chemotherapy agents, helped some advanced lymphoma patients gain some strong response rates.
The study was set up to look at 32 patients in a dose-finding trial of JCAR014 following a round of chemotherapy, called lymphodepletion, with the idea to create “a more favorable environment for the CAR-T cells to grow in the patient’s body,” according to Juno.
It said in a statement that the main point of the study was that it showed the “importance of the choice of lymphodepletion regimen and the effects of different doses of CAR-T cells.”
Data showed that half of the 18 patients who could be reviewed from this test and were treated with CAR-T cells and chemotherapy agents fludarabine and cyclophosphamide (Cy/Flu) had a complete response--which, the biotech says, compares favorably to the 8% complete response rate in patients who received JCAR014 plus cyclophosphamide-based chemotherapy without fludarabine.
In patients using the Cy/Flu lymphodepletion, and the intermediate dose of JCAR014, the data showed an overall response rate of 82% (9 out of 11 patients) and a complete response rate of 64% (7 out of 11 patients).
Even though the patients were few, they were at an advanced stage and had failed on other meds, so these signals have been seen as encouraging from the biotech.
Juno believes that there could be a read-through from the JCAR014 trial for its other experimental med JCAR017, which is being tested in CD19 positive blood cancers in a Phase I study.
“Like JCAR014, JCAR017 uses a one-to-one ratio of helper and killer CAR T cells, and the company believes it has the potential to be a “best-in-class” treatment for non-Hodgkin lymphoma, chronic lymphocytic leukemia, and adult and pediatric acute lymphoblastic leukemia,” Juno said in a statement.
“This study shows that at the right dose of CAR T cells and lymphodepletion, we can achieve very good response rates for NHL patients who have no other treatment options,” explained Dr. Cameron Turtle, an immunotherapy researcher at the Fred Hutchinson Cancer Research Center and one of the study leaders.
The biotech said that “By controlling the mixture of T cells that patients receive, the researchers can see relationships between cell doses and patient outcomes that were previously elusive. The data also suggest that with a defined one-to-one composition of cells, efficacy of treatment is increased, while toxic side effects are minimized.”
But there were some side effects in the study, with one out of the 11 patients having severe cytokine release syndrome and two with severe neurotoxicity--which was 18% of the evaluable population.
In July, the FDA put a brief halt, which was lifted just a few days later, on its Phase II trial for another one of its investigational meds, JCAR015. The biotech said that four deaths had occurred during its test due to severe neurotoxicity, specifically from cerebral edema.
The biotech blamed a preconditioning agent, namely fludarabine, as the culprit for the deaths. It took this out of the trial and was allowed to continue on by the U.S. regulator.
Juno ended the day slightly down, by 0.5% at the end of play yesterday, but was up by more than 7% after hours when the data were posted. The biotech currently has a market cap of just over $3 billion.