On December 7, 2015 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported, in partnership with its collaborators, that clinical data from separate trials for chimeric antigen receptor (CAR) T cell product candidates, JCAR015 and JCAR014, demonstrated encouraging clinical responses in patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) (Press release, Juno, DEC 7, 2015, View Source [SID:1234508478]).

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JCAR015 and JCAR014 results will be presented in oral and poster presentations, respectively, today at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando.

"We are encouraged by the continued positive results of JCAR015 in adult patients with r/r ALL. We look forward to advancing this product candidate in its ongoing pivotal Phase II trial, with the goal of potentially making it broadly available to patients," said Mark Frohlich, M.D., Executive Vice President, Development and Portfolio Strategy. "The JCAR014 data presented show the addition of fludarabine to cyclophosphamide-based lymphodepletion improves CAR T cell expansion, persistence, and disease-free survival in r/r B-cell adult ALL patients treated with a defined cell product. The continued translational insights from this ongoing trial also demonstrate the importance of depth of response in order to maintain a durable response."

In an oral presentation on Monday, December 7, 2015, Jae H. Park, M.D. of Memorial Sloan Kettering Cancer Center will present, "Implications of Minimal Residual Disease Negative Complete Remission (MRD-CR) and Allogeneic Stem Cell Transplant on Safety and Clinical Outcome of CD19-Targeted 19-28z CAR Modified T Cells in Adult Patients with Relapsed, Refractory B-Cell ALL." Dr. Park will provide updated results on a total of 46 patients treated with JCAR015 in B-cell ALL. Key takeaways include:

Overall complete response (CR) was reported in 37/45 (82%) evaluable patients and minimal residual disease (MRD)-negative CR was reported in 30/36 (83%) patients who achieved a CR and were evaluable for MRD analysis.

r/r B-cell ALL patients who achieve MRD-negative CR have improved survival compared to those who achieve MRD-positive CR.
r/r B-cell ALL patients who achieve MRD-negative CR appear to have comparable survival whether or not they proceed to an allogeneic stem cell transplant.

JCAR015 has consistent efficacy across multiple high risk subgroups, including elderly and multiple relapsed patients.
Severe cytokine release syndrome (CRS) was observed in 11/46 (24%) patients. Severity of CRS correlated with disease burden and was generally reversible.

Grade 3/4 neurotoxicity was observed in 13/46 (28%) patients. As previously disclosed, Grade 5 toxicity was observed in 3/46 (6%) patients, and was assessed to be unrelated to JCAR015 treatment in one of these patients.

In a poster presentation on Monday, December 7, 2015, Cameron J. Turtle, MBBS, Ph.D. of the Fred Hutchinson Cancer Research Center will present, "Addition of Fludarabine to Cyclophosphamide Lymphodepletion Improves In Vivo Expansion of CD19 Chimeric Antigen Receptor-Modified T Cells and Clinical Outcome in Adults with B-Cell Acute Lymphoblastic Leukemia." Dr. Turtle will provide updated results on a total of 30 patients treated with JCAR014 against r/r B-cell ALL. Key takeaways include:

The addition of fludarabine to cyclophosphamide-based lymphodepletion to a defined cell product improves CAR T cell expansion, persistence, response rate, and disease-free survival in r/r B-cell adult ALL.

The CR rate as documented by flow cytometry was 27/29 (93%) of evaluable patients with r/r B-cell ALL. After the addition of fludarabine, 17/17 (100%) of patients had a CR and a complete molecular remission (CMR) rate, as measured by flow cytometry.
Severe CRS was reported in 7/30 (23%) and Grade ≥3 neurotoxicity was noted in 15/30 (50%) ALL patients.
The risk-stratified dosing of JCAR014 is potent, feasible, and reduced the incidence of severe CRS.

ASH Investor and Analyst Event and Webcast
The Juno ASH (Free ASH Whitepaper) Investor and Analyst Event and webcast will be held Monday, December 7, 2015 at 8:30 p.m. Eastern 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’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) 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 JCAR015 are investigational product candidates and their safety and efficacy have not been established.