Seattle Genetics $SGEN CEO Clay Siegall ran into a wall of skepticism last summer when he rolled out positive data from their Phase III study of a new cocktail for frontline Hodgkin lymphoma. Dropping the toxic bleomycin from the standard chemo combo used to treat the disease, researchers for the biotech — partnered with Takeda — had come up with a lean but significant 5-point PFS advantage for the company’s flagship therapy.
But in an era of sharp payer kickbacks for marginally impressive drugs, the stock wilted as the doubters pounced on the two-year modified PFS rate of 82.1% compared to 77.2% in the control arm — a 4.9 point, or 6%, improvement.
Siegall, however, arrived in Atlanta this weekend for ASH confident that regulators would favor a program stamped with their “breakthrough” designation. Payers would see the benefits, he added, with the full package of data from ECHELON-1. And physicians and patients, he felt, are clearly willing to embrace the change, particularly as the data are being presented simultaneously now in the prestigious New England Journal of Medicine.
First, he told me, there’s the statistically significant addition of longterm, disease-free survival offering more patients a shot at a potentially curative solution to their disease. Dropping bleomycin, he adds, is a clear benefit. Even at a small rate of pulmonary toxicity, it can be lethal. Carving it out of the treatment regimen will be cheered by every expert in the field.
By physicians involved in the trial, the PFS advantage was 6.3%, with a 27% drop in the risk of disease progression, death or need for another drug.
“Can we get 5%, 6%, 7% more patients cured, eliminate bleomycin and lessen the number of patients with second rounds of chemo and radiation therapy?” says Siegall. “All that together really is an advance and doctors are thrilled when they can.”
“Sometimes you see a therapy add 8, 12 weeks in an endpoint that’s not longterm survival,” says the CEO. “It’s very expensive and won’t necessarily change or cure another segment of the population and reduce toxicity, and there’s some pushback because theres a question of the value.”
That’s not the case here, he feels.
Lymphoma expert John Leonard, though, noted in a Tweet to me that there’s one fly in Seattle Genetics ointment.
As per the RATHL study 75% of patients can drop Bleomycin after cycle 2 ABVD which dramatically reduces bleomycin toxicity – so a big component of this argument goes away
If so, physicians could be more likely to stick with the standard,
An added approval for Seattle Genetics is likely, nevertheless. The FDA has made it abundantly clear that they want to see improvements in cancer care, and is willing to move particularly quickly for approved therapies like Adcetris. And after a fourth OK earlier in the year, Seattle Genetics will be closer to the day when they can count Adcetris as a blockbuster therapy.
“We think there’s a strong value proposition across the board,” he adds.”It is what payers are covering.”
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