Tafasitamab Plus R2 Improves PFS in Relapsed/Refractory Follicular Lymphoma

The addition of tafasitamab-cxix (Monjuvi) to lenalidomide (Revlimid) and rituximab (Rituxan; R2) treatment led to a statistically significant improvement in investigator-assessed progression-free survival (PFS) vs placebo plus R2 alone in patients with relapsed/refractory follicular lymphoma, meeting the primary end point of the phase 3 inMIND trial (NCT04680052).¹ 

Topline findings also indicated that the study demonstrated improvements in investigator-assessed PFS in the overall population and positron-emission tomography complete response (PET-CR) rate in the FDG-avid population, meeting key secondary end points of the trial. Blinded independent review–assessed PFS, another secondary end point, was also consistent with PFS results per investigator assessment. No new safety signals with tafasitamab were seen.

In accordance with these results, Incyte intends to file a supplemental biologics license application for tafasitamab treatment in patients with follicular lymphoma whose disease has failed at least 1 prior systemic anti-CD20 immunotherapy or chemoimmunotherapy regimen by the end of the year.

Complete results from the trial will be submitted for presentation at an upcoming medical conference.

“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 of Incyte, stated in a news 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 is a humanized Fc-modified cytolytic CD19-directed monoclonal antibody currently indicated for use in combination with lenalidomide in the US and the European Union for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.^1,2

As part of the global, double-blind, randomized, controlled phase 3 inMIND trial (NCT04680052) investigators evaluated tafasitamab plus R2 vs R2 alone in patients with histologically confirmed, relapsed/refractory grade 1 to 3a follicular lymphoma or relapsed/refractory nodal, splenic, or extranodal marginal zone lymphoma (MZL). The study enrolled 654 adults at least 18 years of age with an ECOG performance status of 2 or less, adequate systemic organ function, and high tumor burden per GELF criteria. Eligibility criteria required patients to have received at least 1 prior systemic anti-CD20 therapy and included those with anti-CD20–refractory disease.

Per the study design patients will be randomly assigned 1:1 to receive 12 mg/kg of intravenous (IV) tafasitamab on days 1, 8, 15, and 22 for the first 3, 28-day cycles, then on days 1 and 15 through cycle 12, plus 20 mg of oral lenalidomide daily on days 1 through 21 for 12 cycles, and 375 mg/m2 of IV rituximab on days 1, 8, 15, and 22 of cycle 1, then day 1 through cycle 5; or placebo, which will be administered as a 0.9% IV saline solution, plus lenalidomide and rituximab.

The primary end point of the study is PFS per investigator assessment by Lugano 2014 criteria in the cohort of patients with follicular lymphoma. Secondary end points are PFS in the overall population of patients with follicular lymphoma and MZL as well as PET-CR and overall survival in patients with follicular lymphoma.³

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://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-pivotal-study
2. Monjuvi. Prescribing information. Morphosys; 2020. Accessed August 16, 2024. https://www.pfizermedicalinformation.com/en-us/zithromax
3. A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared to placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma or marginal zone lymphoma. ClinicalTrials.gov. Updated August 15, 2024. Accessed August 16, 2024. https://clinicaltrials.gov/study/NCT04680052