The Japanese Ministry of Health, Labour and Welfare has approved the use of Adcetris (brentuximab vedotin) in combination with standard chemotherapy as a frontline treatment for CD30-positive Hodgkin’s lymphoma patients in Japan.
The decision was based on data from the Phase 3 ECHELON-1 clinical trial (NCT01712490), where the combination reduced the risk of disease progression, death, or need for additional cancer therapies by 23%, compared with chemotherapy alone.
ECHELON-1 included 1,334 classical Hodgkin’s lymphoma patients with advanced (stage 3 or 4) disease, and who had not received any prior treatment. It compared the effects of standard chemotherapy — Adriamycin (doxorubicin), bleomycin, vinblastine, and dacarbazine (ABVD) — versus a combination of Adcetris and chemotherapy without bleomycin.
After a median follow-up of two years and six months, 82.1% of patients were still alive, without signs of disease progression or the need for additional treatment. In the chemotherapy group, the figure was 77.2%.
The combination also showed a trend toward better survival rates, but few deaths have occurred to date (28 in the Adcetris arm and 39 in the chemotherapy group), and the results have not yet reached statistical significance.
Patients receiving Adcetris exhibited less lung toxicity, and no new adverse events were reported. The removal of bleomycin from the chemotherapy regimen is likely the reason for this improvement.
“This approval marks another important milestone in expanding the Adcetris brand globally and redefining the way newly diagnosed Hodgkin lymphoma patients are treated around the world,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a press release.
Adcetris is an antibody-drug conjugate, developed by Seattle Genetics and Takeda, to target CD30, a protein widely produced by lymphoma cells. Once it binds to CD30, the molecule releases a toxic compound into cancer cells, causing them to die.
Adcetris is currently approved in the U.S. for five lymphoma indications, including for previously untreated, advanced classical Hodgkin’s lymphoma, an approval that was also based on ECHELON-1 data.
Other approvals include a consolidation therapy for Hodgkin’s lymphoma, treatment for relapsed classical lymphoma patients, for patients with systemic anaplastic large cell lymphoma who failed at least one prior chemotherapy, and for certain patients with skin lymphoma who received a prior systemic treatment.
In Europe, Adcetris is approved for similar indications, but not yet for untreated classical Hodgkin’s lymphoma patients.