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Novartis Says Phase III Kymriah Trial In Aggressive B-cell NHL Did Not Meet Primary Goal

Swiss drug major Novartis (NVS) announced Tuesday that its Phase III BELINDA study investigating Kymriah (tisagenlecleucel) did not meet primary endpoint of event-free survival for patients with aggressive B-cell non-Hodgkin lymphoma or NHL.

The BELINDA study investigated Kymriah as second-line treatment in aggressive B-cell NHL, who had primary refractory disease or who relapsed within 12 months of first-line treatment.

In the study, treatment with Kymriah was compared to treatment with the standard-of-care or SOC, which was salvage chemotherapy followed in responding patients by high-dose chemotherapy and stem cell transplant.

The safety profile was consistent with the established safety profile of Kymriah.

Novartis said it will complete a full evaluation of the BELINDA data and work with investigators on the future presentation of the results.

Kymriah is a CD19-directed genetically modified autologous T cell immunotherapy. In its approved indications, Kymriah is an efficacious treatment offering potential for durable responses and a favorable safety profile based on clinical and real-world experience in more than 5,300 patients to date.

Kymriah demonstrated strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma, with regulatory filings on track for second half of 2021.

The company said the study investigators will work together with it in the coming weeks and months to understand the factors that contributed to this outcome.

Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, said, "Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting. We remain committed to accelerating development of Kymriah and our next-generation CAR-Ts and anticipate sharing early clinical results for these therapies at an upcoming medical meeting."

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