Novartis Kymriah pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

  • Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion1

  • Robust response observed in heavily pretreated patients in critical need of a potentially definitive treatment option1,2

  • No patients in ELARA trial experienced grade 3/4 cytokine release syndrome, the most common side effect associated with CAR-T therapy1

  • Global regulatory submissions based on the ELARA trial on track for later this year

Basel, June 2, 2021 - Novartis today announced robust data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL)1. Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Abstract #7508; oral presentation: Monday, June 7, 10:30 AM CDT).

"Patients with follicular lymphoma who do not respond to their current treatment or who relapse early after treatment often have to endure multiple treatments, which can result in diminished clinical outcomes with each successive therapy," said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research in Penn’s Perelman School of Medicine and director of the Lymphoma Program at the Abramson Cancer Center. Schuster will present the results at ASCO. "Our goal as researchers is to continue to explore the potential of CAR-T therapy, and the robust ELARA safety and efficacy findings suggest Kymriah may play an important role in the third-line treatment of relapsed or refractory follicular lymphoma."

In the primary ELARA analysis, 97 patients were infused and evaluated for safety, 94 patients were evaluable for efficacy with a median follow-up of 11 months. Importantly, no patients experienced grade 3/4 cytokine release syndrome (CRS), the most common side effect associated with CAR-T therapy. Grade 1 or 2 CRS, as defined by the Lee Scale, occurred in 49% of patients. Grade 1 or 2 neurological events (NEs) (per CTCAE v4.03) occurred in 9% of patients and one patient experienced grade 4 NEs and recovered. Sixty-five percent of patients experienced grade

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