Second generation of I-SPY 2 TRIAL design is driving the “precise” in precision medicine
Groundbreaking I-SPY 2.2 TRIAL, an innovative trial model Revolutionizing the Treatment of Early Stage, High-Risk Breast Cancer
I-SPY Family of Trials
Washington D.C, Sept. 16, 2024 (GLOBE NEWSWIRE) — Quantum Leap Healthcare Collaborative™ (QLHC), a non-profit organization and sponsor of the I-SPY 2.2 TRIAL™, presented an overview of the remarkable progress achieved by the I-SPY 2.2 clinical trial today at the National Press Club. This new and unique trial design is extremely patient-centered and represents an important milestone in delivering personalized treatment to improving the outcomes (both efficacy and toxicity) of early stage breast cancer patients who are at high risk for early recurrence. The I-SPY 2.2 trial has an impact far beyond breast cancer by instantiating efficiencies that promise to dramatically improve the pace of trials and accelerate the development and delivery of more effective therapies for other cancer types and a range of other diseases.
It is estimated that 310,720 women and 2,800 men will be diagnosed with breast cancer in the United States this year and 42,250 will die from their disease. Ninety-five percent of breast cancer diagnoses are defined as “early stage”. Of these, 62 percent of these breast cancers are confined to the primary site and 31 percent have spread to regional lymph nodes. The risk of recurrence depends on several factors, but approximately 25 percent of patients (78,000/year) will be told that their risk of early recurrence is high. I-SPY 2.2 set as its goal to prevent recurrence in these early stage high-risk patients – which will result in a cure for this population of patients.
“I have spent much of my career trying to improve the outcomes of women with this early stage (potentially curable) aggressive breast cancer. I-SPY 2.2 is the latest in the I-SPY family of trials and introduces a very patient friendly and straightforward trial design. Ultimately, the goal is to find and develop biologically targeted treatments that help get each patient to the best possible outcome, with the least toxicity. I firmly believe this trial is going to do just that,” said Dr. Laura Esserman, founder and Co-Principal Investigator of I-SPY2.2, Director, UCSF Breast Care Center, University of California, San Francisco (UCSF).
In the conventional adjuvant treatment for these early stage, high-risk individuals, surgery happens before drug treatment with a 3-5 year wait to determine whether the cancer returns. I-SPY2.2 changes this standard to receive treatment before having surgery (neoadjuvant) and introduces a patient-centered design that engages patients in their own care, while still achieving scientific goals of testing agents in sequence. This adaptive platform trial design enables us to optimize therapies through treatment redirection, escalating to the next block if the current block of therapy is resulting in a big enough response, or de-escalating if it looks like a complete response is achieved, allowing women to proceed to the surgical part of treatment and avoid toxic therapies that they likely do not need. Treatment re-direction is based on individual’s own response to the treatment, based on imaging and biopsy.
This is achieved by a groundbreaking trial design leveraging early end points and a Sequential Multiple Assignment Randomized Trial (SMART) design which demonstrates how we can individualize care successfully within the trial and still achieve the ability to compare individual drugs and sequences of treatment.
I-SPY2.2 is shifting the way trial design can and is executed. “Traditional trial design uses a ‘one drug during one trial’ design, focusing solely on a singular outcome. Additionally, a new trial must be created to test and shift treatment. We can test 5 or more different treatments (or combination of treatments) at once. This allows us to be nimbler in our care of patients and respond to their needs more quickly and efficiently, said Dr. Angela M. DeMichele, who, for over a decade was the I-SPY2.2 TRIAL Clinical Trial Operations Working Group Chair, and is Professor in Breast Cancer Excellence at the Perelman School of Medicine at the University of Pennsylvania.
Thus far, I-SPY 2 has enrolled more than 3,000 patients at 43 U.S. sites and by the end of 2024 over 30 drugs will have entered the trial. To date, 10 drugs have graduated from the trial – with 2 receiving accelerated approval and one gaining breakthrough designation by FDA. The design of I-SPY 2.2 increases the throughput of drugs going through the evaluation process, thereby reducing the time and cost of clinical trials and getting approved agents to the patients faster with better outcomes.
I-SPY2.2 continues to evolve for the better; focusing on becoming even more patient-centered by developing a combined end point of both efficacy and less toxicity, testing patient-reported outcomes (PROs) to serve as a quantitative measure of the burden of side effects of treatment. Additionally, we are assessing the value of prospective measurement of circulating tumor DNA and RNA (liquid biopsy) to our MRI and biopsy algorithm to predict outcomes (3 and 5 year survival without disease progression) early.
“Having been involved with I-SPY2.2 from its beginning, I believe this represents a new generation of clinical trials that puts patients and their specific disease at the center of what really is a “smart trial”. It has already served as the prototype for new adaptive platform trials in pancreas and glioblastoma as well as other diseases such as Alzheimer’s disease. This is the future of clinical trials for many reasons, but mostly the best example of precision oncology available today,” said Anna Barker, Chair of the I-SPY2.2 Oversight Group, Board Member, Quantum Leap Healthcare Collaborative and Co-Director and Chief Strategy Officer at the Ellison Institute.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501c(3). A nonprofit pioneer that designs, implements, and succeeds at building and iterating creative and nimble solutions that drive meaningful results for patients. Our mission is to better serve patients by accelerating and innovating health care through approaches that challenge the status quo of science and care. All our efforts focus on achieving our long-term vision to improve human health for all through personalized medicine by bridging the gap between research and care. QLHC provides operational, financial, and regulatory oversight to I-SPY. For more information, visit www.quantumleaphealth.org.
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CONTACT: Jacqueline Murray Quantum Leap Healthcare Collaborative 415.839.8082 j.murray@quantumleaphealth.org
