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.