Quantum Leap Healthcare Collaborative (Quantum Leap) and Athenex, Inc. will present the findings of the I-SPY 2 TRIAL evaluation of oral paclitaxel plus encequidar in combination with GSK's dostarlimab in the neoadjuvant setting at this year's American Society of Clinical Oncology (ASCO) conference. Athenex, a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions collaborated with GSK and Quantum Leap in two study arms of the I-SPY2 TRIAL. The two arms included oral paclitaxel plus Encequidar in combination With GSK's Dostarlimab, an investigational antibody binding PD-1, with and without carboplatin followed by adriamycine and Cytoxan.

The goal of the study was to evaluate the safety and efficacy of oral paclitaxelplus encequidar with dostarlimab +/- carboplatin in Stage 2/3 HER2- breast cancer patients and plus trastuzumab in HER2+ patients. The ultimate goal was to determine if this course of treatment increased the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone for any of the tumor subtypes established at trial entry, and to determine the predictive probability of success in a subsequent Phase 3 trial. In December, Quantum Leap, who sponsored the trial, reported that oral paclitaxel plusEncequidar in combinationwith a PD-1 inhibitor and carboplatin had graduated in the triple-negative subgroup of high-risk early-stage breast cancer.

The I-SPY 2 TRIal, sponsored by Quantum Leap, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage 2/3). GSK provided dostarlimab. Athenex provided oral paclitaxel and encequidar.