— 80% overall response and 60% complete response
— No severe cytokine release syndrome to date and 14% rate of severe neurotoxicity
— Side effect profile plus cell persistence suggest potential for combination therapy
SEATTLE, WA, USA I December 5, 2016 I Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced encouraging preliminary clinical data for JCAR017 in patients with relapsed or refractory (r/r) aggressive non-Hodgkin lymphoma (NHL) in a presentation at the 58th American Society of Hematology (ASH) Annual Meeting. JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development.
“Our potential best-in-class CAR T candidate, JCAR017, has demonstrated an impressive early response rate in these sick NHL patients,” said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. “In particular, the side effect profile and persistence of CAR T cells that we observed, even in patients who relapsed, will allow us to explore higher doses and the possibility for combination therapies to potentially increase durable response rates.”
In the multi-center Phase I trial (ASH Abstract #4192), led by principal investigator Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, patients with r/r diffuse large B cell lymphoma (DLBCL), follicular lymphoma grade 3B or mantle cell lymphoma (MCL) were treated with fludarabine/cyclophosphamide (flu/cy) lymphodepletion and JCAR017.
Key data include:
In 22 safety-evaluable patients (19 r/r DLBCL, 1 follicular lymphoma grade 3B, and 2 MCL patients) treated at dose level 1, single-dose schedule, no severe cytokine release syndrome (sCRS) was observed. Grade 3-4 neurotoxicity was observed in 3/22 (14%) patients, all of whom received the steroid dexamethasone for neurotoxicity. A single patient received tocilizumab for early onset grade 2 CRS. The most frequently reported treatment-emergent adverse events were neutropenia (100%), decreased appetite (36%) and fatigue (32%).
In 20 efficacy-evaluable patients with r/r DLBCL (N=19) and follicular lymphoma grade 3B (N=1) treated at dose level 1 (5×107 cells), single-dose schedule, the overall response was 16/20 (80%) and complete response (CR) was 12/20 (60%) patients.
For DLBCL patients treated more than three months prior to the data cut-off date, 8/19 (42%) patients continue to experience an ongoing response.
In dose level 2 (1×108 cells), 2/2 (100%) patients evaluable for efficacy have a complete response, and no patients evaluable for safety to date (N=3) have had sCRS or grade 3-4 neurotoxicity.
In addition, multiple patients had persistent cells at relapse, suggesting the potential for combination therapy to improve long-term outcomes. One of these patients subsequently achieved a second complete response after endogenous re-expansion of persistent T cells without second infusion.
The Phase I TRANSCEND trial continues, enrolling more patients at dose levels 1 and 2. Juno intends to initiate a pivotal trial in the U.S. in patients with r/r DLBCL in 2017. JCAR017 is also being studied in a Phase II study in children with r/r acute lymphoblastic leukemia.
ASH Investor and Analyst Event and Webcast
A Juno ASH Investor and Analyst Event and webcast will be held Monday, December 5, 2016 at 8:30 p.m. Pacific Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the event.
ABOUT JUNO
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
SOURCE: Juno Therapeutics
Post Views: 23
— 80% overall response and 60% complete response
— No severe cytokine release syndrome to date and 14% rate of severe neurotoxicity
— Side effect profile plus cell persistence suggest potential for combination therapy
SEATTLE, WA, USA I December 5, 2016 I Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced encouraging preliminary clinical data for JCAR017 in patients with relapsed or refractory (r/r) aggressive non-Hodgkin lymphoma (NHL) in a presentation at the 58th American Society of Hematology (ASH) Annual Meeting. JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development.
“Our potential best-in-class CAR T candidate, JCAR017, has demonstrated an impressive early response rate in these sick NHL patients,” said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. “In particular, the side effect profile and persistence of CAR T cells that we observed, even in patients who relapsed, will allow us to explore higher doses and the possibility for combination therapies to potentially increase durable response rates.”
In the multi-center Phase I trial (ASH Abstract #4192), led by principal investigator Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, patients with r/r diffuse large B cell lymphoma (DLBCL), follicular lymphoma grade 3B or mantle cell lymphoma (MCL) were treated with fludarabine/cyclophosphamide (flu/cy) lymphodepletion and JCAR017.
Key data include:
In 22 safety-evaluable patients (19 r/r DLBCL, 1 follicular lymphoma grade 3B, and 2 MCL patients) treated at dose level 1, single-dose schedule, no severe cytokine release syndrome (sCRS) was observed. Grade 3-4 neurotoxicity was observed in 3/22 (14%) patients, all of whom received the steroid dexamethasone for neurotoxicity. A single patient received tocilizumab for early onset grade 2 CRS. The most frequently reported treatment-emergent adverse events were neutropenia (100%), decreased appetite (36%) and fatigue (32%).
In 20 efficacy-evaluable patients with r/r DLBCL (N=19) and follicular lymphoma grade 3B (N=1) treated at dose level 1 (5×107 cells), single-dose schedule, the overall response was 16/20 (80%) and complete response (CR) was 12/20 (60%) patients.
For DLBCL patients treated more than three months prior to the data cut-off date, 8/19 (42%) patients continue to experience an ongoing response.
In dose level 2 (1×108 cells), 2/2 (100%) patients evaluable for efficacy have a complete response, and no patients evaluable for safety to date (N=3) have had sCRS or grade 3-4 neurotoxicity.
In addition, multiple patients had persistent cells at relapse, suggesting the potential for combination therapy to improve long-term outcomes. One of these patients subsequently achieved a second complete response after endogenous re-expansion of persistent T cells without second infusion.
The Phase I TRANSCEND trial continues, enrolling more patients at dose levels 1 and 2. Juno intends to initiate a pivotal trial in the U.S. in patients with r/r DLBCL in 2017. JCAR017 is also being studied in a Phase II study in children with r/r acute lymphoblastic leukemia.
ASH Investor and Analyst Event and Webcast
A Juno ASH Investor and Analyst Event and webcast will be held Monday, December 5, 2016 at 8:30 p.m. Pacific Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the event.
ABOUT JUNO
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
SOURCE: Juno Therapeutics
Post Views: 23
