On June 4, 2016 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported that its investigational chimeric antigen receptor (CAR) T cell product candidates are demonstrating encouraging clinical outcomes for adults and children with B-cell malignancies (Press release, Juno, JUN 4, 2016, View Source;p=RssLanding&cat=news&id=2175102 [SID:1234513025]). Data will be presented at the 52nd Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, including an oral presentation today on JCAR014 (Abstract #102, Hall D1, 8:48 a.m. CT) and a poster presentation tomorrow on JCAR017 (Abstract #3048, Hall A, Board #370, 8:00 a.m. CT).
"We are encouraged by the continued efficacy and duration of response that we are seeing with our defined cell products in patients with B cell malignancies. We are moving rapidly to start potential registration trials for JCAR017 across a range of B cell malignancies, including ALL, NHL, and CLL," said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. "As our understanding of JCAR017 and JCAR014 evolves, we are increasingly able to study these defined cell product candidates in the outpatient setting, which may allow for greater access to our technologies over time."
JCAR014
Updated results from a randomized Phase I/II study examining JCAR014 in patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL) will be presented today by Cameron Turtle, MBBS, Ph.D., of the Fred Hutchinson Cancer Research Center. Key data include:
In efficacy-evaluable ALL patients (N=34), complete remission was reported in 34/34 (100%) patients and complete molecular remission as measured by flow cytometry (CmR) was achieved in 32/34 (94%) patients. Additionally, 13/20 (65%) had a complete molecular remission as measured by the highly sensitive technique of IGH deep sequencing. In the cohort that received fludarabine/cyclophosphamide (Flu/Cy) lymphodepletion, 22/22 (100%) patients achieved a complete remission, all of which were a CmR. Median disease free survival (DFS) and overall survival (OS) have not yet been reached with patients followed for up to 18 months. Severe cytokine release syndrome (sCRS) was observed in 14/36 (39%) patients and Grade 3 or higher neurotoxicity was observed in 14/36 (39%) patients.
In patients with multiple NHL histologies (N=20), predominantly diffuse large B-cell lymphoma, who received Flu/Cy lymphodepletion followed by JCAR014 dose level 2 (2×106/kg), 16/20 (80%) had an overall response (OR), of which 10/20 (50%) experienced a complete response (CR). CRs continue in 70% of patients, ranging from 3 to 11+ months. sCRS was observed in 2/20 (10%) patients and Grade 3 or higher neurotoxicity was observed in 2/20 (10%) patients. Notably, 16/20 (80%) patients treated with Flu/Cy lymphodepletion followed by JCAR014 dose level 2 were treated in the outpatient setting, and 6/20 (30%) did not require hospitalization during the first 30 days of treatment.
A total of 13 high-risk CLL patients (complex karyotype, del17p, ibrutinib-refractory, ibrutinib-intolerant) received JCAR014 and either non-Flu/Cy (n=2) or Flu/Cy (n=11) lymphodepleting chemotherapy. In the Flu/Cy patients, OR rate was 10/11 (91%) patients, of which 5/11 (45%) patients achieved CR. CRs are ongoing in 100% of these patients with a range of 3 to 19+ months. sCRS was observed in 3/13 (23%) patients and Grade 3 or higher neurotoxicity was observed in 3/13 (23%) patients.
JCAR017
In addition to the adult JCAR014 data presented today, Rebecca Gardner, M.D., of Seattle Children’s, announced results from Seattle Children’s Phase I study of JCAR017 in pediatric and young adults with CD19+ r/r ALL (n=42) demonstrating 39/42 (93%) patients experienced a complete remission, all of which were a CmR by flow cytometry. In patients who received the Flu/Cy preconditioning regimen, 14/14 (100%) achieved a complete remission and a CmR. sCRS was observed in 10/42 (24%) patients and Grade 3 or higher neurotoxicity was observed in 10/42 (24%) patients.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established.

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