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Investigators at Penn’s Perelman School of Medicine who led research, development and clinical trials of CAR T therapy, in collaboration with Novartis, called this approval a massive step with potentially life-saving implications for patients. Schuster led two studies examining CAR T therapy in DLBCL, including research published in the New England Journal of Medicine detailing long-term follow-up of the first cohort of these patients treated with the therapy at Penn and the global, multi-center, Novartis-sponsored trial known as JULIET.
At the 59th American Society of Hematology (ASH) annual meeting, the data presented from the JULIET trial showed an overall response of 53 percent, with 40 percent of patients achieving a complete response, among the 81 infused patients with three or more months of follow-up or earlier discontinuation.
Once they are infused back into patients’ bodies, these newly built cells both multiply and attack, targeting cells that express a protein called CD19.
Tests reveal the army of hunter cells can grow to more than 10,000 new cells for each single engineered cell patients receive—producing durable remission rates in refractory lymphoma—and can survive in the body for years.“Our collaboration with Penn has delivered Kymriah, a transformational therapy and first CAR T to be approved, initially for pediatric and young adult patients with ALL and today for adult patients with DLBCL,” said Liz Barrett, CEO, Novartis Oncology.
This approval includes treatment of diffuse large B-cell lymphoma (DLBCL)—the most common form of non-Hodgkin’s lymphoma (NHL)—as well as high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Food and Drug Administration (FDA) has expanded approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
All of the toxicities resolved on their own or with treatment, and there were no treatment-related deaths.
The treatment modifies patients’ own immune T cells, which are collected and reprogrammed at the Novartis manufacturing facility to potentially seek and destroy the patients’ lymphoma cells.
The Novartis-Penn Center for Advanced Cellular Therapeutics (CACT) opened in 2016 and hosted Vice President Joe Biden at the launch of his Cancer Moonshot initiative, cementing Penn’s role as international innovator in the development and manufacturing of personalized cellular therapies.
Additional leaders of the DLBCL research include Jakub Svoboda, an assistant professor of hematology oncology, Daniel J Landsburg, an assistant professor of hematology oncology, and Sunita D. The single-site trial was also supported by grants from the National Institutes of Health (1R01CA165206), as well as through philanthropic support for the Lymphoma Program at the Abramson Cancer Center of the University of Pennsylvania from James and Frances Maguire and the Frances Maguire Lymphoma Research Fund, Margarita Louis-Dreyfus and Sharyn Berman and the Richard Berman Family Funds for CLL and Lymphomas.
“Many lives may be saved.”In August 2017, Kymriah became the first therapy based on gene transfer ever approved by the FDA when it was authorized for children and young adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The FDA’s action is the latest accomplishment in the alliance between Penn and Novartis, which entered into a global collaboration in 2012 to further research, develop and commercialize Kymriah and other CAR T-cell therapies for the treatment of cancers.
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Many patients in the DLBCL trials experienced a side effect called cytokine release syndrome (CRS).