Quantum Leap Healthcare Collaborative Announces Result of Oral Paclitaxel in Combination with a PD-1 and Carboplatin from I-SPY2 TRIAL at ASCO

SAN FRANCISCO, May 1, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (Quantum Leap) and Athenex, Inc. (Nasdaq: ATNX) will present the 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 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-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.

"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," 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.

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative 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. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/.

About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) 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 Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The Company's current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex's employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit http://www.athenex.com.

SOURCE Quantum Leap Healthcare Collaborative