Adcetris (Brentuximab Vedotin) Combined with Chemotherapy Significantly Improves Event-Free Survival in First-Line Treatment of High-Risk Classical Hodgkin Lymphoma

News on June 8, 2022 /BioValleyBIOON/ -- Takeda's partner Seagen recently presented at the 2022 American Society of Clinical Oncology (ASCO) The results of the phase 3 AHOD1331 trial for CD30-targeted antibody-drug conjugate (ADC) Adcetris (Anshili, generic name: brentuximab vedotin, injectable Bentuximab) were announced at the annual meeting. The trial was conducted byChildrenThe Children's Oncology Group (COG) initiated the study, enrolling high-risk, previously untreated pediatric and young adult patients (ages 2-21) with classical Hodgkin lymphoma (cHL).

The results showed that, as part of a multimodal treatment,Compared with the current pediatric dose-intensified regimen ABVE-PC (Adriamycin [Adriamycin], bleomycin [bleomycin], vincristine [vincristine], etoposide [etoposide], prednisone [prednisone], cyclophosphamide [cyclophosphamide]), treatment with Adcetris combined with standard care dose-intensified chemotherapy AVE-PC (Adriamycin, vincristine, etoposide, prednisone, cyclophosphamide) achieved better event-free survival (EFS).

In this study, 600 children and young adult patients with cHL were randomly assigned to receive either Adcetris (brentuximab vedotin) in combination with AVE-PC (BV-AVE-PC regimen group) or the standard ABVE-PC chemotherapy regimen. The data showed,Compared with the ABVE-PC regimen group, the risk of disease progression or recurrence, second malignancy, or death in the BV-AVE-PC regimen group was reduced by 59%, a difference that is clinically significant.StatisticsStatistical significance (Hazard Ratio [HR]=0.41; p=0.0002)。With a median follow-up of 42.1 months, the 3-year event-free survival (EFS) rate was 92.1% in the BV-AVE-PC regimen group and 82.5% in the ABVE-PC regimen group.

Adcetris Combined with AVE-PC Treatment Shows Good Tolerability in Pediatric PatientsManagementThe safety profile was consistent with the known intensified dose chemotherapy regimen. Grade 3 or higher adverse events, including febrile neutropenia, were comparable between the two groups. The incidence of grade 2 or higher peripheral neuropathy was similar in both groups. No deaths occurred during treatment.

Adcetris is a recognized standard-of-care treatment for adult patients with classical Hodgkin lymphoma (cHL).In the aforementioned Phase 3 AHOD1331 trial, the new event-free survival (EFS) data demonstrated by Adcetris is encouraging,These data will support the submission of a supplemental Biologics License Application (sBLA) for Adcetris to expand its indication to include: high-risk, previously untreated pediatric and adolescent patients with cHL.

Adcetris: The Benchmark Product Redefining First-Line Treatment for CD30-Positive Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system, affecting a type of white blood cell known as lymphocytes. Lymphoma is primarily divided into two major categories: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). What distinguishes HL from other types of lymphoma is the presence of a characteristic cell called the Reed-Sternberg cell, which typically has a special protein on its surface known as CD30—a key marker of HL. Approximately 95% of patients with HL have tumor cells that express CD30.

According to estimates by the American Cancer Society (ACS), in 2022, there will be 8,540 new cases of HL in the United States, and an estimated 920 people will die from the disease.Classical Hodgkin lymphoma (cHL) has a bimodal age incidence, peaking in adolescents and young adults aged 15-30 years, and then again in adults aged 55 years or older.cHL accounts for approximately 6% of all childhood cancers.

Adcetris is an antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting the CD30 protein and a microtubule-disrupting agent (monomethyl auristatin E, MMAE) linked together by a protease-sensitive cross-linker., This conjugation technology is proprietary to Seagen, Inc. CD30 protein is a definitive marker of classical HL, and Auristatin E can inhibit cell division by impeding the polymerization of tubulin. Adcetris remains stable in the bloodstream and releases MMAE after being internalized by CD30-positive tumor cells.

Adcetris is the standard-of-care treatment for relapsed or refractory (r/r) cHL.Developed by Seagen, Takeda reached a licensing agreement in 2009, obtaining the commercial rights to the drug in all countries globally except for the United States and Canada. To date, Adcetris has been approved for up to six indications in more than 70 countries worldwide, with variations in indications across different countries.

In the United States, Adcetris has been approved for six adult indications., including: (1) Combination of Doxorubicin + Vincristine + Dacarbazine (AVD) as first-line treatment for previously untreated (newly diagnosed) stage III or IV classical Hodgkin lymphoma (cHL); (2) Undergoing autologous hematopoieticStem CellscHL with an increased risk of relapse or progression after transplantation (ASCT) consolidation therapy; (3) cHL that has failed autologous HSCT treatment, or is not suitable for autologous HSCT and has failed at least two multi-drug chemotherapy regimens; (4) Combined with cyclophosphamide + doxorubicin + prednisone, as first-line treatment for previously untreated (newly diagnosed) systemic anaplastic large cell lymphoma (sALCL) or other peripheral T-cell lymphomas (PTCL) expressing CD30, includingBlood VesselImmunityBlastic T-cell lymphoma and PTCL not otherwise specified; (5) sALCL that has failed prior treatment with at least one multi-drug chemotherapy regimen; (6) Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) previously treated with systemic therapy.

In China, the National Medical Products Administration (NMPA) officially approved Adcetris (brand name: Adcetris, generic name: brentuximab vedotin, injection of vedotin conjugate) in May 2020 for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma (HL).

Currently, Takeda and Seagen are actively advancing a large Phase III clinical development program aimed at establishing Adcetris as a foundational care drug for treating CD30-positive lymphoma and redefining the clinical first-line treatment of lymphoma. (Bioon.com)

Source of the original text:ADCETRIS^® (brentuximab vedotin) Plus Standard of Care Chemotherapy Demonstrates Superior Event-Free Survival (EFS) vs. Standard of Care Alone in Children and Young Adults with Previously Untreated High-Risk Hodgkin Lymphoma