Oncology
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.
Introduction
Berry has a long history of innovation within oncology, led by our founder Dr. Don Berry, one of the world’s most well-known oncology biostatisticians. Berry has led innovation in platform trials, basket trials, meta-analyses, and research and clinical trials involving cancer screening. Berry designed clinical trials have resulted in multiple drug approvals, including a novel “pan tumor” approval for dabrafenib and trametinib in 2022.
Berry Examples and Case Studies
ISPY-2 is one of the first platform trials ever designed, enrolling patients in 2010 and exploring dozens of therapies for breast cancer in its decade plus implementation. ISPY-2 pioneered the now standard adaptive platform trial approach, investigating multiple arms simultaneously and achieving efficiency through the sharing of controls, the adaptive stopping of arms of efficacy or futility, and the reinvestment of saved resources into new investigational therapies. I-SPY2’s innovation has been the focus of many major editorials in medical journals, for example 4 articles in a 2016 issue of the New England Journal of Medicine. I-SPY2 contains additional innovations such as measuring differential response across a variety of biomarker signatures, recommending future investigation for targeted sets of patients. Many of these recommendationsled to successful phase 3 trials and drug approvals. I-SPY2 also pioneered the use of longitudinal data to drive adaptation, using early patient scans to accurately predict the final endpoint of pCR(pathological complete response).
GBM-AGILE is a platform trial investigating treatments for Glioblastoma multiforme. Incorporating many of the innovative features pioneered in ISPY-2, GBM-AGILE also contains subgroup exploration and adds an option for a confirmatory extension to the trial for therapies that show promise in the phase 2 component, allowing a pathway to approval within GBM-AGILE itself.
ROAR was a basket trial investigating dabrafenib and trametinib in combination for the treatment of 9 rare BRAF cancers. The primary analysis model borrowed information between the 9 groups, reflecting scientific intuition that a successful treatment of one such cancer increases, but does not guarantee, the likelihood of success in the other cancers. This borrowing of information obeys statistical principles dating back to Stein in the 1950s and formalizes the biological intuition of biomarker based treatment. Based on the results of ROAR and other clinical trials, dabrafenib and trametinib were granted the first “pan tumor” approval by the FDA in 2022.
