A 77-Year-Old Woman with DLBCL - Episode 7

R/R DLBCL: Observations From the Re-MIND Study

John M. Burke, MD: I think Re-MIND is a really interesting trial. A lot of people may not know about it just yet. It was presented on at ASH [the American Society of Hematology annual meeting] in 2019 and more recently at some of the summer meetings. This was a retrospective study. The scenario here was that we have a combination of tafasitamab plus lenalidomide that appears to be effective, but the question was, what are the individual contributions of the different drugs? We don’t really have great data on the outcomes with lenalidomide alone. So how much of the benefit here is from the lenalidomide, how much is from the tafasitamab, and how much of it is from the combination?

There are a couple of ways to answer that question. One is to do a randomized trial where you compare the individual arms and the combination arm. Or, you can do what they did instead, which was really innovative. They went back and did a retrospective study. They found more than 400 patients who had been treated with lenalidomide alone, as monotherapy, for relapsed large cell lymphoma. This is more commonly done in Europe, so most of the patients on this trial came from Europe. They did a matched comparison between the L-MIND patients and the patients in this retrospective cohort. So of those 400 patients, they matched them for these covariates, including age, performance status, white blood cell count, and a whole bunch of other factors, to get as close of a matching between the 2 groups as possible. They came up with 70-something patients in each group who were sort of head-to-head comparisons. Of course, they weren’t identical, but when you look at the data they were pretty darn close to being well matched. Then they compared the outcomes in those, I think, 76 patients in each group.

When you look at the overall response rate in the L-MIND cohort, again it was 67%, whereas in the lenalidomide-alone cohort, it was 34%. So, basically almost double the response rate with the combination regimen. The complete remission rate was 40% with the combination regimen versus 13% with single-agent lenalidomide. And the overall survival was significantly improved with the combination regimen compared with single-agent lenalidomide.

As best as we can tell using this innovative design, it would appear that the combination significantly improves outcomes compared with lenalidomide alone. This indicates that the addition of tafasitamab is clearly providing a benefit above and beyond what one would get with lenalidomide alone. I’m sure it was not an easy study to conduct, but they were able to do that without having to conduct a randomized phase 2 or randomized phase 3 trial, and saved a lot of time and money. They were able to make this treatment available to patients more quickly. It’s a neat design, and I’d encourage folks to take a look at the study.

Transcript edited for clarity.


Case: A 77-Year-Old Woman With DLBCL

Initial Presentation

  • A 77-year-old woman presented with loss of appetite, fatigue and shortness of breath
  • PMH: post-menopausal; DM, medically controlled
  • PE: palpable inguinal lymphadenopathy; splenomegaly
  • ECOG PS 1

Clinical Work-up

  • Labs: Hb 9.8 g/dL; all others WNL
  • FEV1 45 %
  • Hepatitis B, C and HIV negative
  • Core needle biopsy of the inguinal node: CD20-positive diffuse large B-cell lymphoma, non-GCB subtype. FISH panel: t(14;18) with a BCL2 rearrangement; no MYC or BCL6 rearrangement
  • Imaging:
    • Whole body PET/CT scan showed FDG avidity the inguinal lymph node region, largest node 3.3 cm; splenomegaly; and a small suspicious lung lesion
  • Bone marrow biopsy: involvement with DLBCL
  • Conclusion: stage IV DLBCL, non-GCB subtype
  • IPI score high-risk; CNS relapse score intermediate risk

Treatment

  • Treated with R-CHOP for 6 cycles
  • End-of-treatment PET/CT demonstrates a Deauville 2 complete remission
  • 1 year later while in surveillance she presents with new cervical, axillary, mediastinal, and abdominal lymphadenopathy
  • Core needle biopsy of an axillary node confirms a relapse of DLBCL, non-GCB subtype
  • Based on her age of 78 years and performance status, you consider her to be transplant-ineligible
  • You elect to initiate tafasitamab + lenalidomide