Seattle Genetics has asked the U.S. Food and Drug Administration (FDA) to expand the label for Adcetris (brentuximab vedotin) to be used in combination with chemotherapy as a first-line treatment in patients with advanced classical Hodgkin’s lymphoma.
The data supporting a supplemental Biologics License Application (BLA) stems from the Phase 3 ECHELON-1 trial (NCT01712490), which showed that Adcetris, together with a combination of chemotherapeutic drugs, increased the time to disease progression compared to standard chemotherapy.
Joseph M. Connors, MD, from the British Columbia Cancer Agency in Canada, will present data from the trial at the 59th American Society of Hematology (ASH) Annual Meeting, Dec. 9–12 in Atlanta.
His presentation, “Brentuximab Vedotin Plus Doxorubicin, Vinblastine, Dacarbazine (A+AVD) As Frontline Therapy Demonstrates Superior Modified Progression-Free Survival Versus ABVD in Patients with Previously Untreated Stage III or IV Hodgkin Lymphoma (HL): The Phase 3 Echelon-1 Study,” demonstrates that the Adcetris-chemotherapy combo reduced the risk of progression, death, or need of additional treatment by 23%.
“There have been no new treatment advances for frontline Hodgkin’s lymphoma in more than 40 years,” Clay Siegall, PhD, Seattle Genetics’ president and CEO, said in a press release.
“Up to 30 percent of the patients diagnosed with advanced disease will experience disease progression after frontline treatment with the current standard of care chemotherapy regimen, representing a significant unmet need to improve the treatment outcome of these patients who are often young adults,” he added.
The trial included 1,334 patients, of which the majority had stage 4 Hodgkin’s lymphoma. The patients, who had a median age of 36 years, were randomly assigned treatment with Adcetris plus chemotherapy or chemotherapy alone.
At two years, 82.1% of Adcetris-treated patients had survived without progressing or requiring additional treatment. The number in the chemotherapy control group was 77.2%.
Other measures, including the number of patients who had a complete eradication of their cancer, tended to be higher among Adcetris-treated patients, but differences were not statistically significant.
At the meeting, Connors will present data from patient subgroups who benefited more from the treatment.
“Results from the ECHELON-1 study demonstrated superior activity of an Adcetris-containing regimen over standard of care, and resulted in FDA Breakthrough Therapy Designation for Adcetris in combination with chemotherapy for frontline advanced classical Hodgkin’s lymphoma. We believe these data represent a significant advance for the patient and physician community and look forward to working with the FDA to complete the review of this new treatment regimen as quickly as possible,” Siegall said.