麻豆传媒

At December's American Society of Hematology virtual meeting, a phase II trial was presented on ibrutinib and rituximab for older patients with newly diagnosed mantle cell lymphoma.

In this exclusive 麻豆传媒 video, study author , of the University of Texas MD Anderson Cancer Center in Houston, discusses the .

Following is a transcript of his remarks:

My name is Preetesh Jain, I'm an assistant professor in the department of lymphoma at MD Anderson Cancer Center in Houston, Texas. And I'm pleased to present a snapshot on the phase II clinical trial which we conducted for elderly patients with mantle cell lymphoma who are previously untreated.

In this clinical trial, we have used a chemotherapy-free combination of ibrutinib with rituximab in 50 elderly patients, more than 65 years of age, who are previously untreated. And these patients received ibrutinib with rituximab for the induction treatment with mantle cell lymphoma. In these 50 patients, the response rate was excellent.

The aim of doing this study was to determine the efficacy and safety of this chemotherapy-free combination for elderly patients, particularly since these patients have multiple comorbidities and may not be able to tolerate intensive chemotherapy. So our aim at Anderson is to develop new therapies for these elderly patients.

And with this combination we have achieved a 90% response rate with the intention-to-treat patients, with 62% CR [complete responses] and these patients responded very well to the therapy, and at the median follow-up of 43 months, overall survival is not reached and only four patients had progressed.

Of note, the trial did not improve patients with high-risk mantle cell lymphoma -- that means those with blastoid/pleomorphic histology, or those with Ki67 of more than 50%. Nevertheless, in those patients who were less than 50% Ki67, the response rate was excellent.

Previously, we have reported that in the relapse setting, ibrutinib and rituximab combination at 4 years had demonstrated 56% CR and 86% overall response rates. And with this frontline trial, the response rate has been excellent. And we are conducting further studies with minimal residual disease, genomic profiling of these patients to understand the predictors of response.

Now, one important thing which came up with this study is that there was a 20% incidence of atrial fibrillation in these patients. And when we carefully scrutinized these patients, we also noted that retrospectively some of these patients, 11 of these patients, had a prior history of atrial fibrillation. And these patients had a propensity to get exaggerated response from ibrutinib in terms of side effects with atrial fibrillation, and this is now carefully scrutinized.

So we were able to identify that these patient had baseline cardiac risk factors which predispose them for cardiac arrhythmia. Therefore it is very important that before giving ibrutinib to elderly patients, we are to carefully scrutinize them with cardiology evaluation, their baseline EKG echocardiogram, and regular follow-up.

So this is one important finding, which came up from the adverse event profile. Otherwise the combination was very safe and done pretty well compared to the chemotherapy combinations. And we are very excited to present this study and we'll be reporting this study soon with the extension of minimal residual disease and genomic profiling data.

We believe that we are coming into the era that chemotherapy-free strategies for treating mantle cell lymphoma are coming to light. And this study and the other study, which we did in young patients, which is , we believe that we have already ushered in the chemotherapy-free treatments with such great response rates.

So we are very excited to conduct this study and look forward to further studies for our patients, and provide them the benefit of these new developments in mantle cell lymphoma.

Thank you very much.

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