Seattle Genetics Inc. (SGEN)’s newly approved cancer medicine Adcetris was well tolerated when combined with more established medicines, the company said, potentially positioning the drug for wider clearance.
None of the 19 patients in one segment of the clinical trial experienced lung damage, an issue that led Seattle Genetics to halt an earlier test, the Bothell, Washington-based company said today. The results were released at the American Society of Hematology meeting in San Diego.
“We have an awesome opportunity to redefine front line therapy,” Clay Siegall, chairman, president and chief executive officer of Seattle Genetics said in an interview at the conference today.
Adcetris was approved in August for patients with Hodgkin lymphoma for whom other therapies have failed, the first new medicine cleared by U.S. regulators for the disease since 1977. Seattle Genetics reported sales of $10 million from the medicine’s first six weeks on the market.
The trial, the first of three typically required for regulatory approval, tested Adcetris in newly diagnosed patients. The drug was combined with a chemotherapy regimen containing adriamycin, vinblastine and dacarbazine, a standard treatment called AVD.
“Becoming part of first-line treatment would significantly increase the target population by a factor of four to five,” said Jason Kantor, an analyst at RBC Capital Markets in San Francisco, in an interview. “Most doctors we talk to believe Adcetris will ultimately become part of standard of care.”
In November, the drugmaker discontinued part of the study testing Adcetris with the other medicines and the antibiotic bleomycin, after patients experienced significant complications, prompting shares to drop the most in nine years.
Patients in both groups experienced side effects, including nausea, fatigue, vomiting and neutropenia, a blood condition in which chemotherapy patients suffer from a drop in white blood cells and are at risk for infections.
Hodgkin lymphoma, a cancer of the immune system, will be diagnosed in an estimated 8,830 U.S. patients this year, killing about 1,300, according to the National Cancer Institute.
Seattle Genetics said it will conduct a Phase 3 clinical trial comparing how Adcetris and AVD work in newly diagnosed patients with patients taking AVD and bleomycin. The company is developing the drug with the Millennium unit of Osaka, Japan- based Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker.
Seattle Genetics fell less than 1 percent to $17.02 at the close in New York. The shares have gained 14 percent this year.
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