5-Year Survival Rates Promising for MTLC Patients Treated with Adcetris in Phase 1 Trial

5-Year Survival Rates Promising for MTLC Patients Treated with Adcetris in Phase 1 Trial

Seattle Genetics reported promising five-year survival results from its Phase 1 clinical trial of Adcetris (brentuximab vedotin) in mature T-cell lymphoma (MTCL), also known as peripheral T-cell lymphoma.

The findings show that 80% of patients were alive five years after receiving a combination of Adcetris plus cyclophosphamide, doxorubicin, and prednisone (CHP). And 52% remained disease-free. Importantly, no patients died or had progressed since a three-year follow-up.

The results from the Phase 1 trial (NCT01309789) were presented at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in the poster, “Five-Year Survival Results: Frontline Brentuximab Vedotin in Combination with CHP in Patients with CD30-Expressing Peripheral T-Cell Lymphomas.”

The trial included 26 MTCL patients who received the Adcetris combination.

Of 19 patients with systemic anaplastic large cell lymphoma (sALCL), 16 had a type of the disease called ALK-negative, which has a poor prognosis. Another seven patients had other types of MTCL. Most had advanced-stage disease. All of the patients responded to treatment, with 92% showing a complete response and 8% achieving a partial response.

Peripheral neuropathy, or damage to peripheral nerves, was seen in 19 of 26 patients, with most cases being grade 1 or 2. Grade 1 ranges from no symptoms to a loss of deep tendon reflexes, tingling, tickling, pricking, numbness, or a burning sensation in the skin. Grade 2 involves moderate symptoms that limit the activities of daily living. These symptoms completely disappeared or had partially improved in 95% of the patients during the most recent follow-up.

“Approximately 4,000 patients are diagnosed with MTCL each year. The current standard of care for frontline MTCL treatment has not changed for several decades and there remains a significant need for improved therapeutic options,” Jonathan Drachman, chief medical officer and executive vice president of research and development at Seattle Genetics, said in a press release. “The results of this phase 1 trial support the ongoing phase 3 ECHELON-2 clinical trial and our goal to redefine frontline MTCL treatment with a novel ADCETRIS combination regimen.

Drachman said that no patients had experienced disease progression since the end of the three-year follow-up period, and “after more than five years of follow-up, patients who remain in remission have the potential to be cured.”

Data from the ongoing Phase 3 ECHELON-2 trial (NCT01777152) are expected in 2018, he said. That trial is a placebo-controlled study designed to test Adcetris plus CHP versus CHOP chemotherapy as a first-line treatment for patients with CD30-expressing MTCL. The trial included 452 patients who received either Adcetris plus CHP or CHOP.

MTLC is a non-Hodgkin lymphoma affecting T-cells, one of the two major kinds of white blood cells. Most T-cell lymphomas are in a category called mature T-cell lymphoma, a group of aggressive lymphomas that begin in mature T-cells.

Janet Stewart is a life sciences writer and editor, who completed both PhD course work and oral examinations in the Department of Microbiology and Immunology at McGill University, and holds an M.Sc. in Virology and Immunology.
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Janet Stewart is a life sciences writer and editor, who completed both PhD course work and oral examinations in the Department of Microbiology and Immunology at McGill University, and holds an M.Sc. in Virology and Immunology.

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