On December 18, 2019 Quantum Leap Healthcare Collaborative (QLHC), sponsor and manager of the I-SPY TRIALs for Breast Cancer, reported an evaluation of two drugs developed by Regeneron in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, QuantumLeap, DEC 18, 2019, View Source [SID1234552486]). This treatment arm will focus on the release of immune checkpoints, an increasingly accepted strategy for improving outcomes in breast and other cancers. Monoclonal antibodies that target the immune checkpoint receptors lymphocyte-activation gene 3 (LAG-3) and programmed cell death protein-1 (PD-1) have shown enhanced clinical antitumor activity when given in combination.

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This study arm will evaluate Regeneron’s Libtayo (cemiplimab), an IgG4 antibody that binds to PD-1, and REGN3767, an analogous antibody that binds to LAG-3 to disrupt non-redundant inhibitory pathways to further restore exhausted T-cell function in order to target immune pathways.

The goal of this study is to evaluate the safety and efficacy of Libtayo + REGN3767 when used in the neoadjuvant chemotherapy setting in combination with paclitaxel in HER2- patients followed by doxorubicin hydrochloride /cyclophosphamide chemotherapy (AC) and surgical resection of breast tissue.

"The I-SPY 2 TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add Libtayo and REGN3767, into I-SPY 2, with the goal of determining whether adding Libtayo and REGN3767 to standard neoadjuvant paclitaxel and AC, increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone, for the biomarker signatures established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing phase 2 randomized, controlled, multicenter study 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 II/III). Regeneron will provide funding and the drugs, Libtayo and REGN3767.

Libtayo and REGN3767 are currently under clinical development for breast cancer, and their safety and efficacy have not been evaluated by any regulatory authority for this disease.

About REGN3767 and Libtayo

REGN3767 is a fully human monoclonal antibody that binds with high affinity to the immune checkpoint receptor LAG-3 on T-cells. Once bound, REGN3767 is designed to block suppressive LAG-3 signals and take the brakes off T-cell killing of cancer cells.

Libtayo is a fully-human monoclonal antibody designed to target the immune checkpoint receptor PD-1 on T-cells to block suppressive signals. It is approved in the U.S., European Union, Canada and Brazil for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

About the I-SPY TRIALs

The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) 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 ispytrials.org.