Quantum Leap Healthcare Collaborative and Athenex Announce the Selection of Oral Paclitaxel plus Encequidar in Combination with dostarlimab, an anti-PD-1, in the I-SPY 2 TRIAL targeting Stage 2/3 HER2+ and HER2- Breast Cancers
Athenex’s oral paclitaxel plus encequidar is being evaluated in combination with GSK’s dostarlimab in the neoadjuvant chemotherapy setting
Company to host conference call and webcast today at
The primary objective is to determine whether this regimen increases 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.
The primary endpoint is to assess objective response rates, as measured by pCR. This measurement will occur after the end of therapy during pathologic assessment of residual disease. pCR is defined as no residual invasive cancer in the breast (at the time of definitive surgical resection) or in the lymph nodes (no invasive tumor as determined by hematoxylin and eosin [H&E] stain).
Secondary endpoints include safety assessments and additional information on response to be obtained by measuring the change in MRI volume before, during and after therapy in order to calculate the change in residual cancer burden (RCB) at time of pathologic assessment of residual disease.
This regimen has several innovative components including: (1) assessment of extending PD-1 blockade to HER2+, (2) an orally bioavailable investigational paclitaxel that may be more convenient and tolerable over many more cycles compared to the IV formulation, and (3) the assessment of the impact of carboplatin on efficacy across all tumor subtypes, which may drastically enhance outcomes for some patients.
“We’re very excited to enter this treatment combination into the trial,” noted
“Our NDA for oral paclitaxel and encequidar was accepted by the FDA for Priority Review in metastatic breast cancer. We are very excited to evaluate oral paclitaxel plus encequidar in early stage breast cancer, by participating in the I-SPY 2 trial,” said Dr.
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 will provide dostarlimab.
Conference Call and Webcast Information
To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13709162. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at http://ir.athenex.com/.
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
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
Founded in 2003,
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Corporate Development and Investor Relations
Managing Director, LifeSci Advisors, LLC
Source: Athenex, Inc.