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Takeda and Seagen to highlight at ASCO meeting Adcetris combination data showing statistically significant improvement in overall survival (OS) for advanced Hodgkin Lymphoma.

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Published:28th May 2022

Takeda Pharmaceutical Company Limited and Seagen Inc. announced that overall survival (OS) data from the Phase III ECHELON-1 clinical trial of an Adcetris (brentuximab vedotin) plus chemotherapy combination will be presented in an oral session at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022, 1:00-4:00 PM CT, and at the 27th European Hematology Association (EHA) Annual Meeting on Friday, June 10, 2022, 11:30 – 12:45 CEST.

 

“The longer-term follow-up data from the ECHELON-1 trial have significant clinical importance, as this trial represents one of only two frontline randomized studies in advanced stage Hodgkin lymphoma that shows an overall survival advantage for the experimental arm,” said Stephen Ansell, M.D., Ph.D., Mayo Clinic, and ECHELON-1 study investigator. “These results clearly show that the addition of brentuximab vedotin to chemotherapy improves the long-term outcome of patients and the combination should be considered a standard of care.”

Data from the ECHELON-1 trial demonstrated a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with Adcetris plus doxorubicin, vinblastine and dacarbazine (A+AVD) vs. doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). With approximately six years median follow up (73 months), patients receiving A+AVD had a 41 percent reduction in the risk of death (hazard ratio [HR] 0.59; 95% confidence interval [CI]: 0.396 to 0.879), with an estimated OS rate (95% CI) of 93.9% (91.6, 95.5) at 6 years. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed.

Key findings, which will be presented by Dr. Ansell, include : i. The trial achieved its key secondary endpoint with the combination of A+AVD, resulting in a statistically significant improvement in OS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.59; p-value=0.009). This corresponds to a 41 percent reduction in the risk of death. a. At a median follow up of 73 months, 39 and 64 OS events occurred in the A+AVD and ABVD arms, respectively. b. Estimated six-year OS rates (95% CI) were 93.9% (91.6, 95.5) with A+AVD vs. 89.4% (86.6, 91.7) with ABVD. c. Subgroup analyses supported a consistent benefit for A+AVD vs. ABVD. ii. The six-year PFS estimate (95% CI) was 82.3% (79.1, 85.0) with A+AVD vs. 74.5% (70.8, 77.7) with ABVD. iii. A+AVD resulted in a manageable safety profile consistent with prior reports. a. Treatment-emergent peripheral neuropathy continued to resolve or improve in both arms, with 86% (379/443) and 87% (249/286) of patients in the A+AVD and ABVD arms, respectively, either completely resolving (72% vs. 79%) or improving (14% vs. 8%) by last follow up. b. Fewer patients reported second malignancies in the A+AVD vs. ABVD arm (23 vs. 32). c. No new safety signals were identified.

About the ECHELON-1 Trial : The ECHELON-1 trial, which compared the use of Adcetris in combination with AVD to ABVD in 1,334 patients with previously untreated Stage III or IV classical Hodgkin lymphoma, had a primary endpoint of modified progression-free survival (PFS) per independent review facility (IRF). A key secondary endpoint was OS, which was an event-driven, pre-specified, alpha-controlled analysis in the intention-to-treat population.

Condition: Hodgkin Lymphoma
Type: drug

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