The 3-year PFS rate was 57% compared with 44% in the CHOP arm. At a median follow-up of 36.2 months, the median PFS was 48.2 months in patients who received brentuximab vedotin and CHP compared with 20.8 months in patients who were given CHOP. The key findings of this study, which randomized about 450 patients overall was that it did meet the primary end point of PFS. What were the key findings of this trial? How did the regimen's safety profile compare to the standard of care? This was a global, double-blind phase 3 study that randomized patients with advanced PTCL and CD30 positivity to receive either brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone (CHP) or standard CHOP. The ECHELON-2 study is designed could we improve on CHOP treatment for patients with PTCL. Thus far, we haven't seen any positive studies. Several trials have looked at improving treatment CHOP, with the addition of romidepsin or alemtuzumab. Reddy: Until more recently, CHOP has been the standard-of-care therapy for mature T-cell lymphoma with advanced-stage disease. OncLive®: What was the rationale for the ECHELON-2 trial in PTCL? What was the goal of this research? In an interview with OncLive® during an Institutional Perspectives in Cancer webinar on Leukemia and Lymphoma, Reddy, an associate professor of medicine at the Vanderbilt University Medical Center, discussed the significance of the ECHELON-2 trial in PTCL, the need for novel therapies for those with CD30-negative disease, and the excitement surrounding duvelisib in the relapsed/refractory setting. Results presented during the 2019 ASH Annual Meeting showed that the overall response rate (ORR) per investigator assessment was 35% and 54% at the respective doses.2 When evaluated by a blinded independent review committee, the ORRs were 40% and 62%, respectively. In the relapsed/refractory setting, duvelisib has shown promise in the phase 2 PRIMO trial (NCT03372057), where it was evaluated at 2 doses: 25 mg twice daily and 75 mg twice daily. We are still dealing with a group of patients who are CD30 negative and that's quite a significant population that includes PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, and other mature T-cell lymphomas these do not express CD30.” “However, most of the patients on this study had anaplastic large cell lymphoma, which does express CD30. The key finding here is that in patients with CD30-positive, the treatment of choice would be the addition of brentuximab vedotin,” said Reddy. “This is quite a significant improvement that we have seen in PFS compared with the standard treatment of CHOP. Results showed that the brentuximab combination reduced the risk of death by 34% (HR, 0.66 95% CI, 0.46-0.95 P =.024) versus CHOP moreover, the combination led to a 29% reduction in the risk of disease progression or death (HR, 0.71 95% CI, 0.54-0.93 P =.011).1 These data led to the November 2018 FDA approval of brentuximab vedotinfor use in combination with chemotherapy in the frontline treatment of patients with CD30-positive PTCL. In the phase 3 ECHELON-2 trial (NCT01777152), brentuximab vedotin plus CHP was compared with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with CD30-positive PTCL. Now, agents such as duvelisib (Copiktra) are generating excitement in the relapsed/refractory setting. The emergence of brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) in the treatment armamentarium for advanced peripheral T-cell lymphoma (PTCL) led to a shift in the paradigm for patients with CD30 positivity, according to Nishitha M.
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