UCSF Chancellor Susan Desmond-Hellmann discusses the future of oncology
drug development and adaptive clinical trial design and what it means
to patients in an interview with Pharma Strategy Blog’s Sally Church. Here are excerpts from the post:
“What’s really neat about the I-SPY trial is that Laura Esserman, the PI of the trial, is a breast cancer surgeon here at UCSF and has added so much value to the project because she sees patients early and has a unique opportunity to offer neoadjuvant therapy.
Patients are getting their primary therapy before they get surgery, so for imaging and biomarkers – either established or exploratory – it is a fantastic opportunity. The endpoint is pathological complete response, so you can see if the tumor has disappeared or not.”
“It’s a fantastic rapid readout model so you can get answers much more quickly in a year, including pathological specimens, along with the answers from biomarkers and imaging, which are important.
The FDA has allowed a master IND agreement for this study, so it will be possible to move agents in and out of the trial quickly. So if agent A looks promising it can be advanced quickly and more patients put on it, but if agent B looks toxic, it can be discarded quickly. It’s not just a clinical trial but a experimental trial process that gives you a rapid readout of whether the agent works or not.”
“The hope is that you won’t wasting time and money in phase III trials, but most importantly, patients experience on that molecule. If the answer is yes on I-SPY, you then have a biomarker hypothesis for that agent and can then do a more traditional phase III trial having increased your chances of success.”
Read about the i-Spy 2 adaptive clinical trial which was launched on March 17 in Washington.
Watch the video from the Biomarkers Consortium press conference: