ASH: Seattle Genetics, Takeda Show off Data That Secured Latest FDA Approval for Adcetris

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Less than one month after Seattle Genetics grabbed approval from the U.S. Food and Drug Administration (FDA) for Adcetris as a therapy for previously untreated systemic anaplastic large cell lymphoma, the company showed off the data that earned that nod at ASH.

During a presentation at the American Society of Hematology in San Diego, Seattle Genetics and its developmental partner Takeda Pharmaceutical, showed off the Phase III data that demonstrated why Adcetris in combination with CHP (cyclophosphamide, doxorubicin and prednisone) is effective at extending the progression-free survival and overall survival of patients with CD30-expressing peripheral T-cell lymphomas (PTCL). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. The data from the ECHELON 2 Phase III trial was used by the FDA to grant approval less than two weeks after complete submission of the supplemental Biologics License Application, the companies said.

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Key findings from the Phase III trial show that the combination of Adcetris and CHP demonstrated a significant improvement in progression-free survival, which corresponded with a 29 percent reduction in the risk of progression, death or need for additional anticancer therapy for residual or progressive disease, the companies said. After a median follow-up of 36.2 months, the median PFS for patients treated with the combination dose was 48.2 months, compared to 20.8 months in the control arm. Three-year progression-free survival was 57.1 percent compared from the combination treatment to 44.4 percent for control.

Takeda and Seattle Genetics said overall survival was statistically significant compared to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), a current standard of care in patients with CD30-expressing peripheral T-cell lymphomas. The overall survival data corresponds to a 34 percent reduction in the risk of death, the companies said. The estimated three-year OS was 76.8 percent for the Adcetris arm compared to 69.1 percent for CHOP.

Roger Dansey, chief medical officer at Seattle Genetics, said the latest approval for Adcetris was the sixth approval by the FDA for lymphoid malignancies. November’s approval also marked the second FDA approval as a frontline treatment in combination with chemotherapy.

“The data presented today at ASH underscores that the Adcetris combination provides clinically meaningful benefit to patients with previously untreated PTCL and has the potential to be practice changing for these patients,” Dansey said in a statement.

Takeda’s head of oncology clinical research and development Jesús Gómez-Navarro called the results from the ECHELON-2 trial impressive. He said the results build on the efficacy and safety that has been observed with Adcetris in a “variety of CD30-positive lymphomas.”

“The study demonstrated clinically meaningful outcomes and was the first randomized Phase III trial in frontline PTCL to show improvement in overall survival. Establishing an optimal therapy for PTCL has been a challenge for physicians, and these findings represent the progress in addressing the unmet needs of people living with this serious disease. We look forward to working with regulatory authorities in our territory to bring a potential new treatment option to patients with PTCL,” Gómez-Navarro said in a statement.

For Seattle Genetics, this is the latest of presentations at ASH. Over the weekend, the company presented data from three ongoing clinical trials evaluating the combination of Adcetris and Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab). As BioSpace previously reported, one report was initial data from a Phase II trial of the combination in r/r primary mediastinal large B-cell lymphoma. The other data presented included information from an ongoing Phase I/II clinical trial of the drug combination in r/r classical Hodgkin lymphoma, as well as initial data from a Phase II of the combo with Adcetris, Opdivo and bendamustine in children, adolescents and young adults with r/r classical Hodgkin’s lymphoma.

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