Monjuvi plus Revlimid and Rituxan demonstrated improved progression-free survival for sufferers with relapsed or refractory follicular lymphoma, as introduced on the 2024 ASH annual assembly.
For sufferers with relapsed or refractory follicular lymphoma, Monjuvi (tafasitamab-cxix) along with Revlimid (lenalidomide) and Rituxan (rituximab) led to a 57% discount within the danger of illness development or loss of life versus the placebo plus Revlimid and Rituxan, in response to findings from a section 3 trial that have been introduced on the 2024 ASH Annual Assembly.
At a median follow-up of 14.1 months, the median investigator-assessed progression-free survival (PFS) was 22.4 months with the triplet (273 sufferers) versus 13.9 months with Revlimid and Rituxan alone (275 sufferers).
Based on impartial evaluation committee (IRC) evaluation, the median PFS was not but reached with the triplet versus 16 months with the doublet.
“The inMIND section 3 examine met its main finish level of prolonging PFS in relapsed/refractory follicular lymphoma,” Dr. Laurie H. Sehn, lead examine writer of BC Most cancers Centre for Lymphoid Most cancers and The College of British Columbia, in Vancouver, Canada, stated in a presentation of the information. “Profit was noticed in all prespecified subgroups, together with sufferers with POD24 [progression of disease within 24 months of initial diagnosis], [those who were] refractory to prior anti-CD20 monoclonal antibodies, and [those] receiving a number of prior strains of remedy.”
Glossary:
Development-free survival (PFS): time sufferers dwell with out their most cancers worsening or spreading.
Goal response charge (ORR): sufferers who responded partially or utterly to therapy.
Intravenous: therapy given by the vein.
Neutropenia: low white blood cell rely.
Thrombocytopenia: low platelet rely.
Extra efficacy findings from the subgroup evaluation additionally illustrated a PFS profit favoring the investigational routine no matter POD24 standing and refractoriness to anti-CD20 antibody remedy. In sufferers with POD24, the median PFS was 19.2 months with the triplet versus 11.3 months with the doublet. In sufferers with out POD24, the median PFS was 23.6 months versus 16 months with the triplet and doublet, respectively.
In sufferers who have been refractory to anti-CD20 antibody remedy the median PFS was 15 months within the investigational arm versus 8.6 months within the management arm. In sufferers who weren’t refractory to anti-CD20 antibody remedy the median PFS was 24 months versus 18.2 months with the investigational and management regimens, respectively.
With respect to response within the FDG-avid inhabitants the PET-CR charge was 49.4% within the investigational arm (251 sufferers) versus 39.8% within the management arm (254 sufferers). Within the intention-to-treat inhabitants, the target response charge (ORR) was 83.5% within the triplet arm versus 72.4% within the doublet arm.
Extra efficacy findings demonstrated that the median period of response (DOR) was 21.2 months with the triplet versus 13.6 months with the doublet.
The median time to subsequent therapy (TTNT) was not reached with the triplet versus 28.8 months with the doublet.
“The security profile was manageable and in step with anticipated toxicities with these brokers,” Sehn stated, turning to the routine’s toxicity profile.
Among the commonest any-grade treatment-emergent antagonistic results (TEAEs, negative effects) within the Monjuvi and placebo arms, respectively, included neutropenia (48.5%; 45.2%), diarrhea (37.6%; 28.3%), COVID-19 (31.4%; 23.5%), constipation (29.2%; 24.6%), rash (21.9%; 21.3%) and fatigue (21.2%; 15.8%). The most typical grade 3 (extreme) or 4 (life-threatening) TEAEs within the Monjuvi and placebo arms, respectively, included neutropenia (39.8%; 37.5%), pneumonia (8.4%; 5.1%), thrombocytopenia (6.2%; 7.4%) and decreased neutrophil (white blood cell) rely (5.8%; 6.6%), amongst others.
Sehn acknowledged that Monjuvi and placebo dose interruptions or discontinuations due to TEAEs have been related between therapy arms, as have been discontinuations for Revlimid.
Deaths occurred in 5.5% (15 sufferers) of sufferers within the investigational arm versus 8.5% (23 sufferers) of these within the placebo arm.
Most sufferers with follicular lymphoma would require multiple line of remedy, and though immunotherapy is a most well-liked routine for sufferers with relapsed or refractory illness, the DOR of those brokers stays restricted.
The mix of Revlimid and Rituxan has been an FDA-approved routine for sufferers with beforehand handled follicular lymphoma since 2018. The approval was primarily based on knowledge from the section 3 AUGMENT trial, which confirmed an enchancment in PFS versus Rituxan alone. Monjuvi is a CD19-directed monoclonal antibody that induces direct cytotoxic results and improves NK cell and macrophage immune-mediated mechanisms.
A complete of 548 sufferers have been randomly assigned to therapy with Monjuvi (273 sufferers) or placebo (275 sufferers), and 51 (18.7%) and 42 (15.3%) stay on therapy, respectively. A complete of 244 (89.4%) and 229 (83.3%) sufferers within the investigational and management arms, respectively, stay ongoing within the examine. On the time of the evaluation the median variety of cycles acquired was 12 with Monjuvi versus 11 with placebo.
To be eligible for enrollment sufferers not less than 18 years of age wanted to have grade 1 to 3A follicular lymphoma or MZL and acquired not less than one prior line of remedy, together with an anti-CD20 monoclonal antibody. An ECOG efficiency standing of 0 to 2 and no prior publicity to Revlimid plus Rituxan have been additionally required.
Following affirmation of eligibility sufferers have been randomly assigned to the experimental or management arm. Within the experimental arm sufferers acquired 12 milligrams per kilogram (mg/kg) of intravenous (IV) Monjuvi each week for the primary three cycles adopted by each two weeks for cycles 4 by 12; plus 20 mg per day of oral Revlimid on days 1 to 21 for 12 cycles; and 375 mg per sq. meter of IV Rituxan as soon as weekly for the primary cycle and each 4 weeks for cycles two by 5. Within the management arm sufferers acquired IV placebo in the identical schedule as Monjuvi, plus Revlimid and Rituxan by way of the identical dosing schedule because the experimental arm.
“This examine is the primary to validate the strategy of mixing two antibodies for the therapy of sufferers with follicular lymphoma. [Monjuvi] plus [Revlimid] and [Rituxan] may be administered in group in addition to tutorial settings and represents a possible new normal of look after sufferers with relapsed/refractory follicular lymphoma,” Sehn stated in conclusion.
References:
“Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: outcomes from a section 3 examine (inMIND).” By Dr. Laurie H. Sehn, Blood.
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