Seattle Genetics is making history today, after a dozen years of effort, with groundbreaking clinical trial results in the field of cancer drugs. The results pave the way for the first successful “empowered antibody” drug for cancer, and a new therapy for people who have run out of options for fighting Hodgkin’s disease.
The Bothell, WA-based company (NASDAQ: [[ticker:SGEN]]) and its Cambridge, MA-based partner, Millennium: The Takeda Oncology Company, are reporting today that Seattle Genetics’ lead drug candidate, brentuximab vedotin, was able to partially or completely shrink tumors for 75 percent of the 102 patients with Hodgkin’s disease who enrolled in a pivotal clinical trial. Most cancer drugs shrink tumors in fewer than 30 percent of patients. That means Seattle Genetics unequivocally surpassed the usual definition of success, and is now in a position to seek FDA approval to market the drug in the U.S.
“I’ve been doing cancer research and making cancer drugs for 25 years, and these are the kind of data you dream of,” says Clay Siegall, the co-founder and CEO of Seattle Genetics. “We are going to have an amazing impact on patients.”
Even though the patients were the sickest of the sick, their tumors were kept in check for at least six months. Doctors will continue to follow the patients to see how long the tumors remain stable, and ultimately how long the drug helps the patients live. Detailed results from the study will be presented at an upcoming medical meeting.
Armed with this new batch of results, Seattle Genetics now plans to seek FDA clearance in the first half of 2011, and to ask for a faster-than-usual six-month regulatory review that is sometimes granted for lifesaving therapies.
The results are important for several reasons. If the FDA gives the green light, brentuximab vedotin (formerly known as SGN-35) will become a transformative asset for Seattle Genetics, as the company will morph from an R&D-only operation into a more fully integrated company that discovers, develops, and sells pharmaceuticals. Scientifically, the drug is potentially the first of a new class of drugs designed to zero in specifically on cancerous cells, with a potent toxin to give them extra tumor-killing punch. Medically, the drug could offer a new option for many of the 8,500 patients in the U.S. diagnosed with Hodgkin’s each year, as well as other patients with lymphomas that overexpress a protein marker called CD30, which brentuximab is designed to hit.
Millennium, which last year paid Seattle Genetics $60 million upfront to obtain rights to the product outside North America, said its next move will be
