ASH 2023 | Axi-cel in R/R FL: an updated comparison of ZUMA-5 and the SCHOLAR-5 external control cohort
John Gribben, MD, DSc, FRCP, FRCPath, FMed Sci, Barts Cancer Institute, London, UK, comments on the updated 4-year follow-up comparing the clinical outcomes of the ZUMA-5 trial (NCT03105336) of axicabtagene ciloleucel (axi-cel) to that of the SCHOLAR-5 external control cohort. Since the 3-year follow-up, data continue to verify the superiority of axi-cel, when compared to other therapies, for treating relapsed/refractory (R/R) follicular lymphoma (FL). Patients treated with axi-cel demonstrate improved clinical outcomes, as measured by progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS). This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
So ZUMA-5 was our Phase II study looking at CAR T-cell in follicular lymphoma in third line or more. It had no comparative arms, so what we did was a SCHOLAR-5 analysis, which was we looked at real-world data from large cancer institutes around the world to try to assemble a group of patients who were very similar, or as similar as we could find, to the groups of patients examined in the ZUMA-5 study to have a comparative arm...
So ZUMA-5 was our Phase II study looking at CAR T-cell in follicular lymphoma in third line or more. It had no comparative arms, so what we did was a SCHOLAR-5 analysis, which was we looked at real-world data from large cancer institutes around the world to try to assemble a group of patients who were very similar, or as similar as we could find, to the groups of patients examined in the ZUMA-5 study to have a comparative arm. So we’re, if you like, doing a fake Phase III analysis with, of course, all of the caveats that come with that. What that analysis showed us was that the outcome for CAR-T was better than would be expected from the standard of care. And in the update of that, that we’re showing this year, we’ve done an updated analysis of the SCHOLAR-5 data compared to the updated analysis of ZUMA-5, showing a progression-free and an overall survival advantage in both third line and fourth line for CAR-T over conventional therapy. Now, this does not, of course, replace a randomized trial, but it’s very strong evidence that CAR-T is indeed the advance that we believe it is for follicular lymphoma.
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Disclosures
Consultancy: AstraZeneca, AbbVie, Kite – A Gilead Company, Janssen Pharmaceuticals Inc., Novartis
Research Funding: AstraZeneca, Janssen Pharmaceuticals Inc.
Speakers Bureau: AbbVie, A Gilead Company, Janssen Pharmaceuticals Inc., Bristol Myers Squibb
