Takeda Pharmaceutical will present new data on Adcetris (brentuximab vedotin) as first-line therapy for advanced Hodgkin’s lymphoma at the 59th American Society of Hematology (ASH) Annual Meeting, set for Dec. 9-12 in Atlanta.
The Japanese company, along with Seattle Genetics, will share the full data from its Phase 3 ECHELON-1 trial (NCT01712490) of Adcetris in this patient group.
“This year at ASH, we are presenting data that truly has the potential to change how patients with blood cancers are treated,” Dr. Christophe Bianchi, president of Takeda’s Global Oncology Business Unit, said in a press release.
In June, Takeda announced that the trial met its primary objective of prolonging survival without disease progression or the need for an additional therapy — a goal met by 82.1 percent of Adcetris plus chemotherapy-treated patients. By comparison, only 77.2 percent of those in the control group — treated with a combination of chemotherapies — met this goal.
This translated into a 23 percent lower risk of progression, need of an additional treatment or death among patients treated with Adcetris.
At the meeting, researchers will share additional data on how the Adcetris-based treatment was particularly effective in certain patient subgroups. Although there were numerically fewer deaths in the Adcetris group — 28, compared to 39 in the control group — the difference was not statistically significant. Other secondary measures, including the number of patients who saw a complete eradication of their cancer, tended to be better in the Adcetris group, but were not significant.
Safety in the ECHELON-1 trial was similar to that seen in other Adcetris trials, researchers said. Adcetris was linked to more patients getting severe infections if they were not treated with G-CSF prophylaxis. G-CSF is a factor that boosts the production of certain immune and stem cells. Patients in the control group had a higher risk of potentially fatal lung toxicity.
Nonetheless, the results have convinced Takeda to suggest Adcetris as a new frontline therapy in Hodgkin’s lymphoma. Seattle Genetics — which holds the right to Adcetris in the U.S. and Canada — has also submitted a request to the U.S. Food and Drug Administration to approve the treatment for this patient group in the U.S.
“The positive data from the ECHELON-1 trial represents a milestone in the frontline treatment of advanced Hodgkin lymphoma – a population in which one in three patients doesn’t achieve long-term remission after standard frontline therapy,” said Bianchi.
