Adcetris (brentuximab vedotin) as an add-on to first-line chemotherapy significantly extends the time to disease worsening or death in patients with peripheral T-cell lymphoma (PTCL) whose tumors are positive for the CD30 factor, a Phase 3 trial shows.
The randomized, double-blind, multicenter trial, called ECHELON-2 (NCT01777152), compared patients receiving Seattle Genetics‘ Adcetris plus CHP chemotherapy — cyclophosphamide, doxorubicin, and prednisone — with those receiving CHOP chemotherapy — cyclophosphamide, doxorubicin, vincristine, and prednisone — alone. The combination also extended patients’ lives, the researchers report.
“We are excited about the groundbreaking results of the phase 3 ECHELON-2 clinical trial, which demonstrated Adcetris in combination with chemotherapy significantly improved treatment outcomes for adult patients with previously untreated CD30-expressing PTCL compared with the current standard of care (CHOP),” 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 that affects nearly 4,000 patients in the U.S. each year. These patients usually receive some form of chemotherapy as a front-line treatment, but there is still a need to improve response rates and survival outcomes.
Seattle Genetics is now trying to redefine the front-line standard of care for PTCL by introducing Adcetris into the chemotherapeutic regimen given to these patients.
Adcetris is an antibody-drug conjugate that targets the CD30 protein — which is expressed at the surface of many lymphomas, including some PTCL subsets. After binding to CD30-positive cells, the agent releases a toxic compound that causes cells to die.
ECHELON-2 was designed to determine the safety and effectiveness of Adcetris combined with chemotherapy in newly diagnosed CD30-positive PTCL patients who had not yet received treatment.
The trial included 452 patients at sites across North America, Europe, and Asia, 75% of whom had systemic anaplastic large cell lymphoma (sALCL), a subtype of PTCL.
Its primary goal was to determine if Adcetris delayed disease progression or death in the overall population, and secondary measures included the time to disease progression or death in those with sALCL, overall survival, overall response rate, and adverse events.
Results from the trial revealed that, in patients receiving Adcetris, the risk of disease progression or death was reduced by 29% overall, as assessed by an independent facility. In addition, their risk of death was 34% lower than those receiving just CHOP chemotherapy.
The remaining secondary objectives were also met with statistical significance, the researchers reported. Safety was similar in both arms and consistent with the safety profile of Adcetris-chemo combinations seen in other trials.
Additional data will be disclosed at the American Society of Hematology 2018 Annual Meeting, taking place Dec. 1-4 in San Diego.
“Standard of care in PTCL has not changed in several decades and there remains an unmet need for patients,” said Jesús Gomez-Navarro, MD, vice president, head of Oncology Clinical Research and Development at Takeda, which is jointly developing Adcetris with Seattle Genetics.
“These data showed a significant improvement in the primary endpoint of progression-free survival and all key secondary endpoints, including overall survival, along with a manageable safety profile. We look forward to sharing these data with regulatory authorities globally,” he added.
ECHELON-2 was conducted under a special protocol assessment agreement from the U.S. Food and Drug Administration and with scientific advice from the European Medicines agency, meaning that the trial fulfills the requirements for eventual product approval.
“We’d like to thank the many investigators and patients who participated in this study and contributed to this significant milestone for the PTCL community. We look forward to presenting results at the ASH annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA for approval in this setting in the near future,” Siegall said.
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