ASH 2020 | TRANSCEND study: liso-cel shows promise in R/R MCL patients
Michael Wang, MD, University of Texas MD Anderson Cancer Center, Houston, TX, discusses the initial results of the ongoing TRANSCEND-NHL-001 study (NCT02631044), aiming to evaluate the efficacy and safety of lisocabtagene maraleucel (liso-cel) treatment in relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients. In a group of 32 participants with confirmed R/R MCL, very few treatment-related toxicities and adverse events have been reported. The overall response rate was 84%, with 66% of the patients achieving a complete response. While there are some similarities between this study and the ZUMA-2 trial, TRANSCEND uses separate CD8+ and CD4+ T-cell infusions as well as different costimulatory molecules in the treatment. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Transcript (edited for clarity)
The TRANSCEND study is by BMS, Juno and company and it has several cohorts. As we all know, the large cell lymphoma cohort part, it has been published in The Lancet Oncology and the FDA is looking at the data and is pending FDA approval, we hope very soon.
At the ASH 2020, we are reporting the TRANSCEND mantle cell lymphoma part. As we know, this is also a potential pivotal cohort for mantle cell lymphoma relapsed...
The TRANSCEND study is by BMS, Juno and company and it has several cohorts. As we all know, the large cell lymphoma cohort part, it has been published in The Lancet Oncology and the FDA is looking at the data and is pending FDA approval, we hope very soon.
At the ASH 2020, we are reporting the TRANSCEND mantle cell lymphoma part. As we know, this is also a potential pivotal cohort for mantle cell lymphoma relapsed. In this study population, we have 32 patients so far enrolled and ready for a preliminary data report and they have a median prior therapy over three and so far the grade three or four toxicities for CRS and neurotoxicity are very low and the overall response rate is 84% and the CR at 66% and this is indeed a very good set of data balancing the CRS and the low rate of CRS and neurotoxicity with a high response rate and especially the CR rate of 66%. As we know, in the ZUMA-2 clinical trial that I led and published, the overall response rate is 93 and the CR rate is 67%.
So in the Juno clinical trial and the CR rate is as high as 66% and as such, a low cost of a CRS and neurotoxicity. So, this is a very promising therapeutic modality and we are actively enrolling to finish this cohort so that we could make this therapy available to patients as soon as we could and there are also differences with prior studies on mantle cell lymphoma, in that the infusion of CD4 and CD8 is at a one per one ratio but a CD4 cell infusion and a CD8 cell infusion is consecutive. In other word, they are infused separately one after another in all the patients and also the cells infused is between 15 million, 100 million and the 150 million for large cell lymphoma cohort but for mantle cell lymphoma, the main cohort is 100 million cells.
As you can see that there’s a dramatic difference between this one and ZUMA-2 studies that infused two million cells per kilogram. So, two instead of 100 million. I would like to remind everybody, is the core stimulation molecule is for 4-1BB instead of ZUMA-2 with a CD28. I cannot compare it with two clinical trials but this set of data put each other headed in the right context.
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Disclosures
Dr Michael Wang has received grants from Pharmacyclics, Celgene, Janssen, AstraZeneca/Acerta, Juno, Loxo Oncology, VelosBio, BioInvent, Kite Pharma, Verastem, BeiGene, Eli Lilly, InnoCare and Molecular Templates; has received personal fees from Pharmacyclics, Celgene, Janssen, AstraZeneca/Acerta, OMI, Pulse Biosciences, Juno, Loxo Oncology, VelosBio, Targeted Oncology, Kite Pharma, Guidepoint Global, BeiGene, InnoCare and Oncternal; has received non-financial support from Pharmacyclics, Celgene, Janssen and OMI.
