Novartis highlights new CTL019 clinical data showing complete remissions in children and young adults with relapsed/refractory acute lymphoblastic leukemia - Seite 3

Additional CTL019 Highlights at ASH include:

• Randomized, Phase II Dose Optimization Study of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed, Refractory CLL (Abstract #1982; December 6, 5:30 PM - 7:30 PM)[5]
• Cytokine Release Syndrome (CRS) after Chimeric Antigen Receptor (CAR) T Cell Therapy for Relapsed/Refractory (R/R) CLL (Abstract #1983; December 6, 5:30 PM - 7:30 PM)[6]

Humoral Immunity and Plasma Cell Changes in Patients Responding to CD19-Specific Chimeric Antigen Receptor (CAR)-Modified T-cell Adoptive Immunotherapy (Abstract #1110; December 6, 5:30 PM - 7:30 PM)[7]

Other CAR T Highlights at ASH include:

• Novel Chimeric Antigen Receptor T cells for the treatment of CD19-negative relapses occurring after CD19-targeted immunotherapies (Abstract #966; December 6, 5:30 PM - 7:30 PM)[8]
• Novel chimeric antigen receptor T cells for the treatment of Hodgkin lymphoma (Abstract #806; December 9, 7:45 AM)[9]
• Signaling Domain of Chimeric Antigen Receptors Can Reprogram T Cells (Abstract #551; December 8, 3:45 PM)[10]
• Glycopeptide-Specific Chimeric Antigen Receptor Targeting of T Cell Leukemia (Abstract #4803; December 8, 6:00 PM - 8:00 PM)[11]

In July 2014, the FDA designated CTL019 as a Breakthrough Therapy for the treatment of pediatric and adult patients with r/r ALL under the Penn IND. Breakthrough Therapy designation is intended to expedite the development and review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint[12]. Novartis holds the worldwide rights to CARs developed through the collaboration with Penn for all cancer indications, including the lead program, CTL019.

About CTL019
CTL019 uses CAR technology to reprogram a patient's own T cells to "hunt" cancer cells that express specific proteins, called CD19. After they have been reprogrammed, the T cells (now called CTL019) are re-introduced into the patient's blood; they proliferate and bind to the targeted CD19+ cancer cells and potentially kill these tumor cells.

Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established. Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world.