Monjuvi Succeeds in Phase III Trial of Patients with Relapsed or Refractory Follicular Lymphoma

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Incyte has shared positive Phase III results of its CD19-targeting monoclonal antibody, Monjuvi (tafasitamab). The study evaluated the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab. Tafasitamab met its primary endpoint of progression free survival (PFS) in patients with relapsed or refractory follicular lymphoma (FL).¹

In addition to meeting its primary endpoint, tafasitamab met key secondary endpoints in the trial including positron-emission tomography-complete response rate in the FDG-avid FL population.

“While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies,” Steven Stein, MD, chief medical officer, Incyte said in a press release. “These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least one prior therapy.”

Tafasitamab was evaluated in the pivotal Phase III inMIND trial (NCT04680052). The study was a global, double-blind, randomized, controlled trial. It evaluated the clinical benefit of tafasitamab and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory FL. There were 654 participants enrolled in the study.

In July of 2020, tafasitamab was approved in combination with lenalidomide by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients. According to Incyte, this marked the first FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL.²

In a press release from the time of the approval Jean-Paul Kress, MD, chief executive officer of MorphoSys said, “We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials. This approval marks an important step in MorphoSys’ transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases.”

Professor Gilles Salles, MD, chair of the clinical mematology department at the University of Lyon, France, and lead investigator of the L-MIND study added, “The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States. Today’s FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy.”

The approval was made based on results from the Phase II L-MIND study (NCT0239908)—an open label, multicenter, single arm trial. The tafasitamab combination showed an overall response rate of 55%, meeting the study’s primary endpoint. Additionally, the combination achieved a complete response rate of 37%, a partial response rate of 18%, and the median duration of response was 21.7 months.

References

1. Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®) in Relapsed or Refractory Follicular Lymphoma. News release. Incyte. August 15, 2024. Accessed August 16, 2024. https://www.businesswire.com/news/home/20240815184197/en/Incyte-Announces-Positive-Topline-Results-from-Pivotal-Study-of-Tafasitamab-Monjuvi%C2%AE-in-Relapsed-or-Refractory-Follicular-Lymphoma

2. FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL). News release. Incyte. July 31, 2020. Accessed August 16, 2024. https://investor.incyte.com/news-releases/news-release-details/fda-approves-monjuvir-tafasitamab-cxix-combination-lenalidomide