Gilead Sciences company Kite published Phase II data for Yescarta (axicabtagene ciloleucel) for treating relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in Nature Medicine.
Yescarta is CD-19-directed autologous chimeric antigen receptor (CAR)-T cell therapy. It was first approved by the US Food and Drug Administration (FDA) for large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma.
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Yescarta is a high-grossing drug, generating $739m in global sales during H1 2023, as per Gilead’s Q2 financial report. GlobalData forecasts the Yescarta sales to increase to $2.4bn in 2029.
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The open-label Phase II trial (NCT04531046) evaluated Yescarta as a second-line therapy in patients with one prior line of therapy ineligible for high-dose chemotherapy and autologous stem cell transplantation.
The study met its primary endpoint with a complete response rate of 71% and 59.7% in the treatment arm at three and six months, respectively. Negative findings on PET study during or after therapy were considered a complete response.
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By GlobalDataAt 12-month follow-up, median progression-free survival was 11.8 months, median overall survival was not reached, and overall survival was 78.3%.
The commonly observed serious adverse events were Grade 3-4 cytokine-release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS).
In January, The UK National Institute for Health and Care Excellence (NICE) recommended Yescarta for treating relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients who have previously received two or more lines of systemic therapy.
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