Dr. Yan Leyfman, Medical Oncologist, Co-Founder and Executive Director of MedNews Week, shared on LinkedIn:
“Should we rethink how we measure success after CAR T-cell therapy?
Most CAR T-cell studies evaluate efficacy and toxicity separately. A new study proposes a more comprehensive endpoint: TPFS6 (toxicity-free and progression-free survival at 6 months).
TPFS6 is achieved when a patient experiences none of the following within the first 6 months after CAR T:
- Severe cytokine release syndrome (CRS)
- Severe ICANS
- Progressive or stable disease
- Non-relapse mortality
Among patients with relapsed/refractory large B-cell lymphoma:
- 37% achieved TPFS6
- The most common reason for failure was progressive or stable disease (61%), followed by severe ICANS (30%)
- Better performance status (ECOG <2), lower LDH, lower CRP, and female sex were associated with a higher likelihood of achieving TPFS6
Most importantly, patients who achieved TPFS6 had significantly better long-term outcomes:
- 81% lower risk of death (HR 0.19)
- 67% lower risk of progression or death (HR 0.33)
Interestingly, TPFS6 remained strongly associated with survival even after accounting for disease progression, suggesting that avoiding severe treatment-related toxicity has an independent impact on long-term outcomes.
As CAR T-cell therapy continues to evolve, composite endpoints like TPFS6 may provide a more meaningful way to evaluate both the effectiveness and tolerability of treatment.”
Title: A novel severe toxicity-free, and progression-free survival endpoint predicts outcomes after CD19 chimeric antigen receptor-T cell therapy in large B-cell lymphoma
Authors: Aditi Saha, Junmin Whiting, Razan Mohty, Kristen Flores, Jongphil Kim, Taiga Nishihori, Julio Chavez, Sameh Gaballa, Farhad Khimani, Hien Liu, Bijal Shah, Marian Dam, Muhammad Jaffer, Sepideh Mokhtari, Nima Ghalehsari, Hany Elmariah, Christina Bachmeier, Jose Alejandro Guevara, Heather Jim, Sayeef Mirza, Brahm H. Segal, Doris K. Hansen, Nelli Bejanyan, Fabiana Perna, Rawan Faramand, Michael Jain, Frederick Locke, Aleksandr Lazaryan
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