Tafasitamab Regimen Improves PFS in Relapsed/Refractory Follicular Lymphoma

Atthe recent American Society of Hematology (ASH) annual meeting, late-breaking phase III data demonstrated that adding tafasitamab (Monjuvi) to lenalidomide (Revlimid) and rituximab (Rituxan) significantly improved progression-free survival (PFS) in relapsed/refractory follicular lymphoma with no excessive toxicity.

In this final of four exclusive episodes, MedPage Today brought together three expert leaders in the field, all from the Ohio State University Wexner Medical Center. Moderator Kami J. Maddocks, MD, is joined by Yazeed Y. Sawalha, MD, and David A. Bond, MD, for a roundtable discussion on the promising results and how the regimen may fit into the treatment landscape.

Following is a transcript of their remarks:

Maddocks: Welcome back to our ASH 2024 Roundtable. I’m here with Drs. Bond and Sawalha. And the last abstract we’re going to present is actually in anticipation of the data. So we’re going to talk about the late-breaker abstract to be presented, looking at tafasitamab plus lenalidomide and rituximab for relapsed/refractory follicular lymphoma. Dr. Sawalha, do you want to provide us with some thoughts on this?

Sawalha: Yeah, so this is a large phase III randomized placebo-controlled clinical trial where patients get R², or lenalidomide plus rituximab, with placebo or tafasitamab in patients with relapsed or refractory follicular lymphoma.

Most patients in this trial received one prior line of treatment. Tafasitamab is given weekly for the first 3 months and then every other week for the remaining of the 12 cycles. And then R² is per the augmented trial design.

It’s a positive trial, fortunately. So the intervention arm, the [tafasitamab] arm, resulted in superior progression-free survival and higher [complete response] rate, and per the abstract, there seems to be a trend towards improvement in overall survival.

So very exciting data. In terms of safety, there doesn’t seem to be excessive toxicity with the addition of tafasitamab. There seems to be a slight increased number of risk of neutropenia and maybe certain types of infection, but I don’t think they were excessive.

Maddocks: Dr. Bond, any initial thoughts?

Bond: Yeah, yeah, I think with follicular lymphoma we’re seeing a lot of data with multiple agents, but most of it is in the form of, at this point, phase II studies. So I think it’s important that we have now a randomized phase III study with a comparator. And I think the lenalidomide-rituximab control arm is something that is widely used in practice. I think it’s a relevant control arm. And so I think encouraging results, seeing really significant, almost a year longer median progression-free survival for the study arm with tafasitamab and lenalidomide and rituximab. So exciting to see progress being made in follicular lymphoma.

And I think there’s more to come as far as other studies that are expected to come in the coming years. So we’ll have to grapple with how to compare these. But I think at this point it’s really very encouraging data that in my opinion would support the use of this regimen.

Maddocks: So that’s what I was going to ask. Is R² something that you guys are commonly using in follicular lymphoma and how are you incorporating it into your treatment landscape?

Sawalha: Yeah, so it’s the only currently approved non-chemotherapy option for second line because all the other options are approved in third and later lines of treatment. So it’s one of the agents that I commonly use for patients with relapsed FL [follicular lymphoma] as second line.

I would say this trial did include patients with rituximab-refractory disease, and so in real life for some of these patients who might use obinutuzumab (Gazyva) potentially with lenalidomide or other agents, so that could be a caveat of the trial. And as a reminder, the AUGMENT trial didn’t allow rituximab-refractory disease because the control arm was just rituximab. So that’s one thing to keep in mind. But in general, I think [lenalidomide]-based regimens are commonly used, especially in the second line in FL.

Maddocks: So do you think if this phase III trial, positive trial — obviously we always have to wait for our approvals — but probably a high likelihood that this is going to become a treatment option? Do you think it’s going to be something that’s easy to deliver to patients?

Bond: I think it is feasible. I think with the schedule for tafasitamab, it does involve more infusion visits than what patients would expect with just rituximab and lenalidomide. So I think it is a bit more of a commitment in terms of time and more complexity to the regimen. But I think we… tafasitamab is a drug that’s approved in diffuse large B-cell lymphoma, and we have experience using it in that context with lenalidomide, and I think it is something that’s also able to be given in the community. So I do think, in my opinion, it’s something that is feasible to give in real practice.

Maddocks: And as you mentioned, I mean a lot of times we deal with balancing efficacy with safety and walking that line, but it really seems like this potentially really didn’t have a very different safety profile, but a significant improvement in efficacy.

Sawalha: Correct. That was kind of my impression based on the abstract. So we’ll see the detailed safety data, but there didn’t seem to be excessive toxicity. So as my colleague mentioned, I think the one thing with this treatment, the treatment schedule is a little bit more intensive. There are just more infusions and clinic visits with this regimen, but something to discuss with patients. But I think overall the regimen seems very promising too.

Maddocks: OK. Well, I think there’s a lot of ongoing combinations with R², so we may reach a point where we have to, as you mentioned, kind of look at those different data and outcomes and kind of try to decide how do we use these. But for now we look forward to further discussion in the future on this great late-breaking abstract in lymphoma. Thank you guys for joining me.

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