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.
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SOURCE Quantum Leap Healthcare Collaborative
