Armin Ghobadi, MD, on How to Interpret Preliminary Data in Patients with DLBCL
Ghobadi expressed caution about interpreting efficacy data from a phase 1 pilot study presented at the 2020 ASH Annual Meeting.
In an interview with CancerNetwork®, Armin Ghobadi, MD, of the Washington University School of Medicine in St. Louis, detailed which data can be trusted and expressed caution about interpreting efficacy data from a phase 1 pilot study presented at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.
Transcription:
[With a] phase 1 pilot trial, obviously the goal of them is just showing feasibility and safety. You can’t look at the efficacy data from phase 1. You can obviously look at these 10 patients and see how this is effective in this scenario and those kinds of things. I think we see signs of them based on the correlative studies that we did that are interesting in terms of activated T-cells, CD8-to-CD4 ratio, and early on post BEAM [carmustine, etoposide, cytarabine and melphalan] autologous transplant. One hundred percent [of patients are] MRD negative after autologous transplant, [but] you cannot translate that to 100% of people are going to be cured…because that’s not the case. Most likely, this patient will need more than 1 cycle of treatment; several cycles of this T-cell engager at various time points [is] easily given. You can’t look at the result of this and focus on the efficacy end point, basically.
