Policy & Regulation
Seattle Genetics Submits Supplemental Biologics License Application for Adcetris (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas
7 November 2018 - - US-based biotechnology company Seattle Genetics, Inc. (NASDAQ: SGEN) has submitted a supplemental Biologics License Application to the US Food and Drug Administration based on data from the phase 3 ECHELON-2 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma, the company said.

The positive topline results of the phase 3 ECHELON-2 clinical trial were announced in October 2018 and full data will be presented at the upcoming American Society of Hematology annual meeting, December 1-4, 2018 in San Diego, Calif.

Adcetris is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of PTCL. Adcetris is currently not approved for the frontline treatment of PTCL.

The phase 3 ECHELON-2 clinical trial evaluated the combination of Adcetris plus CHP (cyclophosphamide, doxorubicin, prednisone) compared to a recognized standard of care chemotherapy regimen, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in previously untreated CD30-expressing PTCL.

The ECHELON-2 study met its primary endpoint demonstrating a statistically significant improvement in progression-free survival as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110).

The Adcetris plus CHP arm also demonstrated superior overall survival, a key secondary endpoint, compared to CHOP (hazard ratio=0.66; p-value=0.0244).

All other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate were statistically significant in favor of the ADCETRIS plus CHP arm.

The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy.

Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialisation rights and Takeda has rights to commercialize Adcetris in the rest of the world.

Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50: 50 basis, except in Japan where Takeda is solely responsible for development costs.

Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people's lives.

Adcetris (brentuximab vedotin) utilises the company's industry-leading antibody-drug conjugate technology and is currently approved for the treatment of multiple CD30-expressing lymphomas.

Beyond Adcetris, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors.

Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilise our proprietary ADC technology.

Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer.


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