Quantum Leap Healthcare Collaborative™ (QLHC) announced 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.