FDA Gives Adcetris Breakthrough Therapy Status as Firstline Hodgkin’s Treatment

Designation based on ECHELON-1 trial results

The FDA has granted a breakthrough therapy designation to brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination with chemotherapy for the firstline treatment of patients with advanced classical Hodgkin’s lymphoma.

Positive topline results of the phase 3 ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the American Society of Hematology annual meeting in December. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin’s lymphoma. Brentuximab vedotin is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 clinical trials.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.

The ECHELON-1 study “showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin’s lymphoma patients,” said Clay Siegall, PhD, President and Chief Executive Officer of Seattle Genetics. The company intends to submit a supplemental biologics license application to the FDA before the end of 2017.

The randomized, open-label ECHELON-1 study evaluated a combination of brentuximab vedotin plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen in previously untreated advanced classical Hodgkin’s lymphoma. The study met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the brentuximab vedotin–containing regimen versus the control arm as assessed by an Independent Review Facility (hazard ratio, 0.770; P = 0.035). The two-year modified PFS rate for patients in the brentuximab vedotin arm was 82.1% compared to 77.2% in the control arm. Interim analysis of overall survival, the key secondary endpoint, also trended in favor of the brentuximab vedotin plus AVD arm. The safety profile brentuximab vedotin plus AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen.

Brentuximab vedotin for intravenous injection has received approval from the FDA for three indications: 1) regular approval for the treatment of patients with classical Hodgkin’s lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, 2) regular approval for the treatment of classical Hodgkin’s lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and 3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Source: Seattle Genetics; October 2, 2017.

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