In a closely watched result, Adcetris, a cancer drug sold by the biotech firm Seattle Genetics and the Japanese drug giant Takeda, outperformed traditional chemotherapy in front-line Hodgkin lymphoma, a result that is likely to lead to a broadened approval from the Food and Drug Administration.
The result is seen as a key one for Seattle Genetics’ stock, which rose dramatically last year but has increased 17%, half as much as the biotech indices, in 2017. Shares sank last week after studies of an experimental drug, vadastuximab talirine, were stopped due to an elevated death rate with the treatment.
So the success of the Adcetris study, called Echelon-1, is welcome news. The study compared Adcetris to a chemotherapy, bleomycin, on top of a three-drug chemotherapy regimen (adriamycin, vinblstin, and dacarbazine). Adcetris reduced the risk of disease progression — defined as worsening cancer, death, or need for additional cancer treatment — by 23%. At two years, 82.1% of patients who had received Adcetris had not seen their cancer progress, compared to 77.2% in the control arm.
Full results are expected to be presented at the annual meeting of the American Society of Hematology later this year.
Bleomycin can damage the lungs, a side effect that can be life-threatening in a tenth of patients. The long-term side effects can be serious, a big concern given that patients with Hodgkin are often in their twenties or thirties, with a high chance of being cured. “These are mainly young people who will have a lot of years ahead of them,” says Clay Siegall, the chief executive of Seattle Genetics.
But it’s not a blowout finding. The p value, a measure of statistical significance, is 0.035, below the 0.05 threshold of significance but not a lot below it. Siegall says that the control group had a progression-free survival about three to four points higher than in other trials. He also says that a study that tested other cancer drugs without bleomycin found that it added about 6% to progression-free survival rates.
Siegall says that Adcetris will cost about $100,000 to $120,000 for the average first-line Hodgkin patient, depending on the patient’s weight and the exact number of doses given. He points out that treating Hodgkin disease delivers the second greatest financial returns among adult cancers, because it strikes young adults. (Testicular cancer has similar economic costs.) “It’s a little different from drugs that are out there that help cancer patients, but they are aimed at getting a certain percentage of cancer patients a few extra months,” Siegall says.
[Source”timesofindia”]
