On May 1, 2023 Quantum Leap Healthcare Collaborative (Quantum Leap) and Athenex, Inc. (Nasdaq: ATNX) reported that findings of the I-SPY 2 TRIAL evaluation of Athenex’s oral paclitaxel plus encequidar in combination with GSK’s dostarlimab in the neoadjuvant setting will be presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference (Press release, QuantumLeap, MAY 1, 2023, View Source [SID1234630796]).
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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-SPY 2 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 paclitaxel plus 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 plus encequidar in combination with a PD-1 inhibitor and carboplatin had graduated in the triple-negative subgroup of high-risk early-stage breast cancer. Further findings of this study with complete regimen details will be included in the full abstract in June at ASCO (Free ASCO Whitepaper).
"As we continue to improve response to therapy, we have the opportunity to find less toxic, more tolerable regimens that will be as good or better than standard chemotherapy. Our goal for this study was to test a promising PD1 inhibitor in combination with the Athenex oral taxane which was shown to be more effective than paclitaxel in a phase 3 trial in the metastatic setting. Working with companies like Athenex and GSK allows us to test combinations that could improve our ability to deliver combined therapies the world over, and find the best possible outcome for the patients. We are looking forward to sharing our results at this year’s ASCO (Free ASCO Whitepaper)," said Laura Esserman, MD, the leader of the I-SPY 2 study and co-founder of Quantum Leap.
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.