Loretta Nastoupil, MD, University of Texas MD Anderson Cancer Center, Houston, discusses results from a phase 2, single-center study exploring obinutuzumab in combination with lenalidomide in patients with previously untreated, high tumor burden follicular lymphoma (FL). These results were presented at the 2019 ASH Annual Meeting.
Transcript
Loretta Nastoupil: Hi, I'm Loretta Nastoupil from the University of Texas in the Anderson Cancer Center where I'm an Associate Professor in the Department of Lymphoma and Myeloma.
At the American Society of Hematology meeting here in Orlando in 2019, I presented a phase 2, single-center, investigator-initiated study of obinutuzumab in combination with lenalidomide in previously untreated high tumor burden follicular lymphoma patients.
We have years of experience exploring rituximab in combination with lenalidomide in follicular lymphoma, primarily trying to exploit the microenvironment that we think is critical to the survival of follicular lymphoma cells. In our experience, R2 had high efficacy and had a manageable toxicity profile.
We sought out to replace the rituximab with obinutuzumab, which is a second generation CD20 antibody. It's been glycoengineered for enhanced ADCC. Our hypothesis is that we would have further enhancement of the efficacy and ideally not further changes in the toxicity profile.
What we showed in our 90 patients in all high tumor burden, the majority of which were advanced stage, they tolerated the combination quite well. We had very few grade 3 or higher adverse events, with neutropenia being the most common.
10% had grade four neutropenia. Most of those patients did not receive prophylactic growth factors. Only 13%t required reactive growth factor use. As a result, infection was infrequent. We had very few events of neutropenic fever and no grade 5 adverse events have been observed to date.
What was quite striking was the efficacy which, again, was proof of concept in that patients had very rapid and deep responses at the first response assessment. Nearly 90% of patients had achieved a complete response, which was determined by the Lugano 2014 criteria.
Also, that resulted in a striking 2-year PFS estimate of 96%. Again, among the 90 patients enrolled, we only had 3 progression events with, albeit a short-medium follow up of 25 months.
This study was really compelling. Granted, it's a single-center, phase 2 study, but it does warrant further study because the efficacy is quite high and the toxicity profile was very manageable.
