SAN FRANCISCO, Sept. 6, 2018 /PRNewswire/ -- Quantum Leap Healthcare Collaborative™ (QLHC) announced today that a new randomized, investigational treatment arm for the I-SPY 2 TRIAL™ includes the study of olaparib and durvalumab, two agents from AstraZeneca.
Olaparib is a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor and durvalumab is an anti-PD-L1 monoclonal antibody immunotherapy agent. Olaparib and durvalumab in combination with paclitaxel (chemotherapy) treatment will be compared to standard therapy (paclitaxel) alone in the new I-SPY 2 TRIAL treatment arm. Patients with HER2 negative breast cancer who are eligible to participate in the trial will be adaptively randomized into the olaparib/durvalumab/paclitaxel arm, another investigational arm, or standard of care (paclitaxel). Patients will then continue treatment with doxorubicin/cyclophosphamide (AC) regardless of assigned arm, all taking place in the neoadjuvant setting (treatment and/or chemotherapy prior to surgery).
The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). Quantum Leap Healthcare Collaborative (QLHC) is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory.
About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit www.quantumleaphealth.org.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, the Company is committed to advance Oncology as one of Four Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to their core capabilities, AstraZeneca actively pursues innovative partnerships and investments that accelerate the delivery of their strategy.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow on Twitter @AstraZenecaUS.
SOURCE Quantum Leap Healthcare Collaborative
Jeff Matthews, PhD
University of California San Francisco