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Arvinas and Quantum Leap Healthcare Announce Clinical Study to Evaluate Vepdegestrant (ARV-471) in I-SPY-2 Endocrine Optimization Platform (EOP) Clinical Trial
The I-SPY-2 Endocrine Optimization Platform (EOP) study (NCT01042379) will include a vepdegestrant monotherapy arm and a vepdegestrant in combination with letrozole arm. This study is focused on patients with clinically high-risk (stage 2/3) ER+/HER2- breast cancer, but molecularly low risk (MammaPrint low risk signature), a subset of patients with substantial risk for late recurrence.
Quantum Leap opened the EOP program in 2021 to specifically assess treatment options for this subset of patients, and work to find an early endpoint to measure the success of therapy. EOP is a sub-study within the main I-SPY-2 clinical trial utilizing neoadjuvant endocrine therapy in patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit.
"I-SPY TRIALs focus on high-impact experimental treatments that may benefit patients, providers, and researchers, and
"The heart of the I-SPY TRIALs is to change how new breast cancer treatments are developed, to find treatments that are more personalized, effective, and less toxic, faster. We are excited to be partnering with
About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally-bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In
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 Endocrine Optimization Pilot (EOP) is developing better endpoints and new endocrine targeted agents for stage 2/3 molecularly low risk breast cancer. The trial is a unique collaborative effort by a consortium that includes the
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential of the I-SPY endocrine program, the potential for vepdegestrant (ARV-471) to become the standard of care for patients with ER+/HER2- breast cancer, and the potential and therapeutic benefits of our clinical programs, vepdegestrant (ARV-471), bavdegalutamide (ARV-110), and ARV-766. The terms "expect," "potential," "will," "intend," "believe," and "plan," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with the successful conduct and completion of clinical trials and development for
SOURCE Quantum Leap Healthcare Collaborative
Arvinas Contacts: Investors:, Jeff Boyle, Vice President, Investor Relations, (347) 247-5089, Jeff.Boyle@arvinas.com; Media:, Kirsten Owens, Director, Communications, (203) 584-0307, Kirsten.Owens@arvinas.com; Quantum Leap Healthcare Collaborative Media Contact: , Jacqueline Murray, Director, Marketing and Communications, (415) 839-8082, email@example.com