Juno Therapeutics (JUNO) is back in the CAR-T blood cancer game.
Rivals Kite Pharma (KITE) and Novartis (NVS - Get Report) are still out in front, but the updated efficacy and safety data announced Monday from Juno's JCAR017 program in patients with aggressive non-Hodgkin's lymphoma are competitive.
Juno is rebounding from the patient deaths and toxicity reported last year which ultimately forced the shutdown of its JCAR015 program in adult leukemia.
The new Juno efficacy data investors will be talking about: In 32 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the JCAR017 complete response rate at three months was 50%. The overall response rate was 66%.
With CAR-T, especially Juno, safety is key: There were 44 DLBCL patients treated with JCAR017 evaluable for safety. Of these, eight patients, or 18%, reported severe cytokine release syndrome or severe neurotoxicity. There were no deaths related to either of these closely watched CAR-T side effects. A single patient, 82, died from respiratory failure deemed related to chemo pre-treatment and JCAR017.
These new data come from Juno's TRANSCEND study and are being presented Monday at the American Society of Clinical Oncology (ASCO) annual meeting underway in Chicago.
The comparison investors will make between Juno and Kite: Interim (three month) results from Kite's pivotal ZUMA-1 study in 55 relapsed, refractory DLBCL patients showed an axi-cel complete response rate of 33% and an overall response rate of 39%. There were two patient deaths. The rates of severe cytokine release syndrome and neurotoxicity were 18% and 34%.
Final, six-month ZUMA-1 results in 77 DLBCL patients treated with Kite's axi-cel was 31%; overall response rate 36%. The rate of severe cytokine release syndrome was 13%. These are the final axi-cel data submitted by Kite to the FDA for approval to treat DLBCL patients, with a decision expected on or before Nov. 29.
Juno's new JCAR017 data come from a smaller number of patients with less follow up, but so far, the data stack up well against Kite. A Kite spokesperson pushes back against making direct comparisons between JCAR017 and axi-cel, saying the two companies define DLBCL differently.
How does Juno compare to Novartis in DLBCL? We don't know yet. Novartis is scheduled to disclose interim results from its JULIET trial of CTL019 in DLBCL patients at a European blood cancer meeting on June 14.
Juno's next steps: Additional DLBCL patients will be recruited into the TRANSCEND study and treated with JCAR107 starting in the second half of the year. Juno believes this will provide enough efficacy and safety data to file for approval with the FDA. JCAR017 is partnered with Celgene (CELG - Get Report) .
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