Can Adcetris' narrow beat in new trial win a new FDA nod? Seattle Genetics, Takeda hope so

The good news for Seattle Genetics and Takeda: Their blood cancer drug Adcetris hit its primary goal in a Hodgkin’s lymphoma trial.

The not-so-good news? Though Adcetris plus three chemo drugs together held off cancer progression, the combo didn’t perform dramatically better than a standard four-drug chemo regimen.

In previously untreated patients with advanced Hodgkin lymphoma, those taking the Adcetris combo showed an 82.1% lower risk of cancer progression, compared with a 77.2% risk for patients on the standard-of-care chemo.

There’s another important difference between the two regimens, however. The standard chemo is known as ABVD, an acronym of the four meds it comprises. The B stands for bleomycin, a drug that can trigger serious lung problems. Adcetris (brentuximab vedotin) subs in for bleomycin in the regiment, and it’s a chemotherapy delivered by a targeted antibody, designed to reduce side effects.

Still, that 5% difference could be a tough sell with increasingly cost-conscious payers, and investors know it. Seattle Genetics’ shares dropped 11% as the data were released. Overall survival numbers—which, if positive, would trump the progression-free survival stats—aren’t likely to be in for several years.

Seattle Genetics and Takeda plan to file the new data with the FDA, looking to add yet another indication to Adcetris’ label. The drug is already approved for three other uses, two in patients with classical Hodgkin lymphoma, one in those with systemic anaplastic large cell lymphoma.

Dirk Huebner, executive medical director of oncology at Takeda, said the company is excited about the “statistically significant improvement” in “modified” progression-free survival. “The results of this trial signify an important step forward in the development of Adcetris and have the potential to change the treatment approach of frontline advanced Hodgkin lymphoma,” Huebner said.