a pivotal clinical trial this summer to provide more evidence supporting the drug’s effect in this same patient population.
About 62 percent of patients had some clinical benefit when they got the BiPar treatment, which researchers defined as complete or partial tumor shrinkage, or stable tumors for at least six months. Only 21 percent did that well in the control group. When expressed through an important statistical measure known as the hazard ratio, women on the BiPar drug had a 65 percent lower risk of dying than those who didn’t get it. The p-value for this finding was 0.0005, which means there was a 5 in 10,000 possibility that this result was due to chance, or a fluke, which is far greater confidence than the FDA needs to see to approve a new drug.
The most common side effects were neutropenia—a depletion of infection-fighting white blood cells—but there were actually more cases of that in the control group than among those who got the BiPar treatment.
It will be interesting to see what the opinion-makers at ASCO, and the regulators at FDA have to say about these results. Inhibiting PARP is thought to be useful in a number of different cancers, so this could lead to aggressive new investment in the field across the pharma and biotech industry. Nine days ago, when I previewed the importance of this BiPar trial, Vulcan consultant Michael Kranda suggested that a small number of thought leaders who saw the data before today were bowled over by what they saw.
“This is potentially a fundamental advance against solid tumors,” said Kranda, who pulled together the founding syndicate of venture investors in BiPar. “When you talk to the leading companies and the leading doctors in this space, we’re seeing them compare the impact of this to (Novartis’ Gleevec). That drug obliterates tumors, and you don’t see many drugs get mentioned in conversation like that.”
