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MDx/CDx Focus: Phase III Adcetris Trial in Hodgkin Lymphoma; FDA Priority Review for Roche's T-DM1

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Millennium, Seattle Genetics Launch Phase III Adcetris Trial in Hodgkin Lymphoma

Millennium and Seattle Genetics earlier this month initiated a Phase III trial to investigate the efficacy and safety of Adcetris, a drug being developed for the treatment of advanced Hodgkin lymphoma.

Adcetris targets the cell membrane protein CD30, which is expressed in Hodgkin lymphoma. The trial, being conducted under a special protocol agreement with the US Food and Drug Administration, will study Adcetris (brentuximab vedotin) in combination with chemotherapy as a first-line treatment for previously untreated Hodgkin lymphoma patients.

“This is a key step in our efforts to explore the potential of this targeted therapy as part of a front-line treatment regimen,” Karen Ferrante, chief medical officer of Millennium, a subsidiary of Takeda Pharmaceuticals' oncology division, said in a statement.

This trial is part of Millennium and Seattle's ongoing program to identify patient populations with CD30-expressing malignancies that might benefit from Adcetris treatment.

Earlier this year, Millennium and Seattle Genetics launched a Phase III study evaluating Adcetris in previously treated patients with CD30-expressing cutaneous T-cell lymphoma. In this study, the partners are also evaluating a companion test to identify patients with CD30-expressing malignancies. Millennium and Seattle Genetics have inked a deal with Ventana Medical Systems to develop the molecular companion diagnostic test accompanying Adcetris (PGx Reporter 5/9/2012).

Seattle Genetics Chief Medical Officer Thomas Reynolds noted in a statement that there is an unmet medical need for new treatments for Hodgkin lymphoma. This Phase III trial might lead to the development of a new front-line treatment for Hodgkin lymphoma patients, but it also may yield data that the companies can submit to the FDA to garner accelerated approval for Adcetris in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma patients.

The randomized, open-label study will compare Adcetris plus combination chemotherapy (adriamycin, vinblastine, dacarbazine) versus just chemotherapy (adriamycin, bleomycin, vinblastine, dacarbazine) in more than 1,000 patients with advanced, classical Hodgkin lymphoma. Researchers will investigate whether the Adcetris plus chemo regimen improves progression-free survival in patients compared to only chemo based on the Revised Response Criteria for malignant lymphoma. Other endpoints that will be studied include overall survival, complete remission, and safety.


FDA Grants Priority Review to Roche's T-DM1

The US Food and Drug Administration has decided it will review Roche's biologics license application for trastuzumab emtansine under priority review.

Roche is seeking approval for T-DM1 as a treatment for patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy.

When the FDA grants priority review for a product, it commits itself to issue a decision within six months on whether to grant it marketing approval. Roche expects to hear from the FDA by Feb. 26, 2013.

Simultaneously, the European Medicines Agency has also accepted Roche’s marketing authorization application for T-DM1 for patients with HER2-positive metastatic breast cancer.

Roche subsidiary Genentech licensed technology for T-DM1 from ImmunoGen. T-DM1 joins Herceptin with the chemotherapy DM1 via a stable linker. The two bonded agents attach to HER2-positive cancer cells, block abnormal signaling pathways driving tumor growth, and induce the body's immune system to destroy malignant cells.

In a recently reported Phase III study comparing T-DM1 against GlaxoSmithKline's Tykerb (lapatinib) plus Xeloda in 900 HER2-positive advanced breast cancer patients, T-DM1-treated patients experienced median overall survival of nearly 31 months, compared to 25 months for patients receiving the Tykerb/Xeloda regimen (PGx Reporter 10/3/2012).

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