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Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas
By: News Feed | Last updated: 21st November 2018 | In: Chemotherapy, Haematology, US FDA Onc\Haem Approvals
Adcetris, AITL, ALCL, brentuximab vedotin, BV-CHP, CD30, CHOP, CHP, cyclophosphamide, doxorubicin, FDA, lymphoma, prednisone, PTCL, PTCL-NOS, sALCL, Seattle Genetics, vincristine
On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL) such as angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).
The double-blind, multicentre ECHELON-2 trial (NCT01777152) randomised 452 patients in 1:1 ratio to either receive brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (BV-CHP) or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The primary efficacy endpoint was progression-free survival (PFS) by independent review, defined as time from randomisation to progression, death due to any cause, or administration of a subsequent anticancer chemotherapy for residual or progressive disease.
In the BV-CHP group the median PFS was 48.2 months (95% CI, 35.2-not estimable) compared to 20.8 months (95% CI, 12.7-47.6) in the CHOP group (HR=0.71; 95% CI, 0.54-0.93; P=0.011). The overall survival was improved for patients on BV-CHP compared to those on CHOP (HR=0.66; 95%CI, 0.46-0.95; P=0.024) with higher complete response rates of 68% vs 56% (P=0.007) and overall response rates of 83% vs 72% (P=0.003) both for the BV-CHP vs CHOP group, respectively.
Common adverse reactions of ≥20% incidence and observed ≥2% of patients receiving BV-CHP included nausea, diarrhoea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anaemia. Peripheral neuropathy occurred in 52% and 55% of patients in the BV-CHP and CHOP arm, respectively.
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