Understanding the Science Behind the Monjuvi Approval in Lymphoma

Dr. Christina Poh, a hematologist-oncologist, discussed the clinical trial that led to the FDA approval of Monjuvi (tafasitamab-cxix) in combination with Revlimid (lenalidomide) and Rituxan (rituximab) for adults with relapsed or refractory follicular lymphoma.

The FDA granted approval based on results from the inMIND trial, a double-blind, placebo-controlled study involving 548 patients. Participants were randomly assigned to receive either Monjuvi or placebo alongside Revlimid and Rituxan. Most patients had received one prior systemic treatment, while 25% had two and 20% had three or more.

Poh explained that the trial was carefully designed to be large and well controlled—considered the most reliable way to evaluate treatment effectiveness. Notably, the study included a broad range of patients, including those with aggressive or treatment-resistant lymphoma. The treatment demonstrated benefits across all groups, providing a promising new option for individuals facing this disease.

She serves as a physician at Fred Hutch Cancer Center, located in Seattle, Washington, as well as an assistant professor in the Division of Hematology and Oncology at University of Washington School of Medicine.

CURE also sat down for an interview with a patient who was on the inMIND trial; he saw lymph nodes shrink 85%, with stable results a year later, supporting the approval. In the interview, he discusses his experience on the trial.

Transcript

What aspects of the trial's design or patient population do you think were key to demonstrating the benefits of this combination?

There were a few important things about the trial that helped us show that this treatment can really help people with follicular lymphoma. So first, the trial was designed very carefully. It was large, well controlled study where it was randomized and placebo controlled, so neither the patients nor the doctors actually knew who was getting the treatment or the placebo. And so this kind of study is considered the most reliable way to test if a treatment actually works. Second, the trial included a wide range of patients, and that was reflective of who we doctors see in real life. So included patients who had tougher cases of follicular lymphoma, more aggressive cases, patients who whose lymphoma didn't respond to previous their treatments, or who had their disease come back really quickly after their last treatment. And the encouraging thing about this regimen is that this new treatment helped across all the different groups.

Transcript has been edited for clarity and conciseness.

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