Research & Development
Seagen Receives US FDA Approval of New Indication for Adcetris for Children with Previously Untreated High Risk Hodgkin Lymphoma
14 November 2022 - - The US Food and Drug Administration has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide, US-based Seagen Inc. (NASDAQ: SGEN) said.

The approval is based on data from a phase 3 study (AHOD1331) conducted by the Children's Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving Adcetris in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-free survival compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide).

Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.0002).

Hodgkin lymphoma is blood cancer that starts when lymphocytes, a type of white blood cell, grow out of control.

It represents about 6% of all childhood cancers and is the most common cancer diagnosed in adolescents ages 15 to 19 years.

About one-third of all Hodgkin lymphoma patients are classified as high risk, typically stage IIB, IIIB, and IVA or IVB.

People with cHL have abnormal white blood cells that usually have a special protein on their surfaces called CD30, a key marker of cHL.

AHOD1331 is a National Cancer Institute -sponsored study conducted by the Children's Oncology Group, and is the largest multicenter, randomized, open-label phase 3 immunotherapy study ever conducted with newly diagnosed high risk Hodgkin lymphoma pediatric patients.

The study enrolled 587 patients from 2 to 21 years of age across 151 institutions who had previously untreated HL stages IIB + bulk, IIIB, IVA and IVB.

Patients were randomized to five cycles of either standard of care dose-intensive chemotherapy (Adriamycin [doxorubicin], bleomycin. vincristine, etoposide, prednisone and cyclophosphamide [ABVE-PC]) or brentuximab vedotin plus AVE-PC (BV-AVE-PC) given every 21 days with granulocyte colony-stimulating factor support.

The primary objective was event-free survival; events included relapse/progression, second malignant neoplasm or death. Seagen provided brentuximab vedotin for the study.

Adcetris is an antibody-drug conjugate comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E, utilizing Seagen's proprietary technology.

The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives.

Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union.
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