- Results from a Phase 1 study assessing Juno Therapeutics' (NASDAQ:JUNO) JCAR014 in heavily pretreated patients with chronic lymphocytic leukemia (CLL) who failed to respond to AbbVie's (ABBV) IMBRUVICA (ibrutinib) showed an encouraging treatment effect. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- The 24 participants in the study had received a median of five previous therapies, including ibrutinib. All failed and had poor prognoses. Three failed prior allogeneic stem cell transplants. All received lymphodepletion therapy prior to receiving JCAR014.
- 88% (n=15/17) of efficacy-evaluable patients experienced a complete bone marrow response determined by flow cytometry while 50% (n=7/14) had no detectable disease. All seven were alive and progression-free during the follow-up period (3 - 26 months).
- Two of 24 (8%) patients developed grade 3 (severe) to grade 5 (death) severe cytokine release syndrome (CRS) while 25% (n=6/24) developed grade 3 - 5 neurotoxicity. The most frequent severe treatment-emergent adverse events were febrile neutropenia (75%), CRS (29%), fever (17%), lung infection (13%), encephalopathy (13%) and hypotension (13%). There was one treatment-related death in a patient who developed CRS and cerebral edema.
- JCAR014, part of Juno's CD19-focused CAR T program, is being co-developed and will be co-commercialized with Celgene (CELG). A study assessing JCAR014 in combination with ibrutinib in CLL should start in early 2017. The data generated in the JCAR014 studies will support a potential Juno-sponsored study of JCAR017 in CLL.
- The company will host an investor and analyst event and webcast tomorrow, Monday, December 5, at 11:30 am ET to discuss the data.