Thursday, January 4, 2024

ASH Review: Long-Term Results

Welcome to 2024, everyone. I hope it's a healthy, happy year for you all. 

I'm still "cleaning up" all of the Follicular Lymphoma news items that I have been saving from the last couple of months. Here are two more presentations from ASH that are worth sharing. In the write-ups I saw after the conference, both were presented as good "long-term" results -- meaning 3 years. 

The first is #603 "Mosunetuzumab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year Follow-up from a Pivotal Phase II Study." 

The presentation looks at FL patients with Relapsed/Refractory disease who received Mosunetuzumab. As you probably remember, Mosunetuzumab is a bispecific antibody, so it attaches to both lymphoma cells and to the T cells that might eliminate them. The early results from this phase 2 trial were very strong (it was a phase 2 trial that led to Mosunetuzumab being approved by the FDA). By looking at these patients after 3 years, researchers were able to show that the treatment is effective over time, and that new side effects have not developed (or if they have, they were manageable).

For the 90 patients in the study, the Overall Response Rate after 3 years was 77.8%, with the Complete Response rate at 60%. The median Duration of Response was just under 3  years. In that time, 57.1% of the patients remained disease-free. Another 37.8% of them had received another treatment for their lymphoma, including 5 who received another dose of Mosunetuzumab (3 of the 5 achieved a Complete Response from that second round of he bispecific).

As for side effects, there were no new cases of Cytokine Release Syndrome (CRS) or serious side effects. Overall, side effects were comparable to those that were reported in the two-year follow-up. 

The researchers say that this follow-up shows that Mosunetuzumab remains effective and safe even after three years.

The second presentation is #601 "Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up."Lots of interesting parallels with the Mosunetuzumab presentation above. It's a 3 year follow-up of a phase 2 trial for an approved treatment, involving R/R Follicular Lymphoma patients. In this case, it is the CAR-T treatment known as Tisa-Cel, or Kymriah. 

The trial involves 94 patients who were evaluated. The Overall Response rate was 86%, and the Complete Response rate was 68%. The median Duration of Response was not yet reached (which means more than half of the patients in the trial still had a response after 3 years). As for safety, no new side effects were reported, and the most common serious side effects were CRS, pneumonia, and neutropenia (low white blood cell counts). 

Like the Mosunetuzumab researchers, the Tisa-Cel researchers believe that the treatment has great potential. They are especially hopeful that the treatment will be effective for POD24 patients (those who relapse within 24 months of receiving immunochemotherapy).

As I have been saying for a while, it is these two types of treatment -- Bispecifics and CAR-T -- that seem to get Lymphoma experts most excited these days. And these presentations just gave them more reason to be excited. 

More good things to come. Have a great year, folks.


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