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 for patients with peripheral T-cell lymphoma (PTCL) whose tumors are positive for the CD30 factor.
Data from the Phase 3 ECHELON-2 trial (NCT01777152), presented in October, supported the supplemental biologics license application (BLA).
The Phase 3 trial compared patients randomized to Seattle Genetics‘ Adcetris plus CHP chemotherapy (cyclophosphamide, doxorubicin, and prednisone) to those receiving CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) alone.
The 452 trial participants were newly diagnosed with CD30-positive PTCL patients and had not received any prior treatment.
The results showed that the combo therapy significantly extended the time to disease worsening or death compared to standard chemotherapy. Moreover, the combination also extended patients’ lives.
Specifically, in patients treated with Adcetris, the risk of disease progression or death was reduced by 29% overall, and their risk of death was 34% lower than controls.
“Results from the ECHELON-2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and importantly, overall survival, in patients with previously untreated CD30-expressing PTCL who were treated with Adcetris in combination with CHP chemotherapy over standard of care CHOP chemotherapy,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a press release.
CD30-positive PTCL is an aggressive type of non-Hodgkin’s lymphoma affecting almost 4,000 patients in the U.S. each year. Patients’ front-line treatment has been the same for several decades, relying on some form of chemotherapy, but the response rates and survival outcomes are in need of improvement.
“We believe these superior results over standard of care represent a significant advance for patients with CD30-expressing PTCL and for the medical community, and we look forward to working with the FDA during the review process of this application to bring this potential new treatment regimen to patients as quickly as possible,” Siegall said.
Adcetris is an antibody-drug conjugate that targets the CD30 protein, which is located at the surface of many lymphomas, including some PTCL subsets. Once bound to CD30-positive cells, the antibody triggers the release of a toxic compound that causes cells to die.
The full data of the ECHELON-2 trial will be presented at the upcoming American Society of Hematology (ASH) 2018 Annual Meeting, Dec. 1-4 in San Diego, California. The presentation is titled “The ECHELON-2 Trial: Results of a Randomized, Double-Blind, Active-Controlled Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas.”
