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the difference between being bedridden or able to walk around or climb stairs. Taken a step further, a more vigorous patient might be able to withstand higher doses of chemotherapy or further rounds of anti-tumor drugs, rather than go home to die.
Alder tested this original hypothesis in a small study, to assess safety, in nine patients. The first batch of results were presented at last year’s ASCO conference. The Alder drug was found safe in three different doses of an intravenous infusion. There also were a couple anecdotal cases of patients who were bedridden and waiting to die who were able to get out of bed after infusion. They regained weight and resumed chemotherapy, Schatzman says.
It would be hard to overstate how radical an idea this is to the world of oncology and to the FDA. There is only one gold standard measurement for success in cancer drug development, and that’s whether a drug can help people live longer. Given the time and expense it takes to demonstrate that in a clinical trial, the FDA and cancer experts will sometimes be satisfied with leading indicators of success, like whether a new drug can keep tumors from spreading through the body for a longer time than the standard of care, or whether it does a better job of shrinking tumors. While cancer drugmakers often ask patients in clinical trials to fill out questionnaires about their quality of life, that’s generally considered a mushier, subjective measurement that would never be sufficient evidence to win FDA approval.
Alder knows exactly what it is up against, in terms of the conventional wisdom of cancer physicians and the FDA. But Schatzman says the data that Alder has in hand from a more ambitious mid-stage trial of 124-patients is compelling enough that his team is in the midst of designing a pivotal clinical trial of ALD518 that could show the drug improves quality of life, and helps people live longer. Alder hasn’t finalized the design of this study, but Alder is preparing to budget $50 million of its own money on this trial.
“We could change how physicians view cancer, and change the treatment of it,” Schatzman says.
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