In an interview, Dr. Thomas Lynch, director of the Yale Cancer Center in New Haven, Conn., and a member of the American Association for Cancer Research’s annual meeting program committee, praised the novel design of the I-SPY 2 trial, "the fact that it allows rapid evaluation of both biomarkers and new drugs and the interaction between biomarkers and new drugs.
"It’s not a definitive [trial] design; it’s not going to lead to drug approval in and of itself. But it does have a lot of power to sort out which biomarkers and which agents are the most important to combine and look at in putting together treatments for patients," Dr. Lynch said.
He went on to describe the findings regarding neratinib as "intriguing, but I have to see a bigger study to have a sense of magnitude of benefit. What the interaction of the biomarker is, is hard to know."
The study is sponsored by the QuantumLeap Healthcare Collaborative, a 501(3) charitable foundation. Dr. Park said that he had no relevant financial conflicts to disclose. Dr. Lynch disclosed that he is on the board of directors of Bristol-Myers Squibb and Infinity Pharmaceuticals, and that he receives honoraria and stock from both companies. He is also on the scientific advisory board of Arvinas and receives honoraria and stock from that company. In addition, Dr. Lynch is a patent holder with Partners Healthcare for an EGFR mutation testing patent and receives royalties.