Quantum Leap Healthcare Collaborative™ and G1 Therapeutics announced a collaboration to evaluate trilaciclib, an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy, in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast cancer.

"The I-SPY 2 TRIAL is designed to evaluate agents with the goal of accelerating the pace of promising effective and potentially less toxic treatments to patients who are most likely to benefit quickly. We are excited to include trilaciclib in I-SPY 2, with the goal of determining whether adding trilaciclib to neoadjuvant chemotherapy-based treatment, either with or without an immune checkpoint inhibitor, increases the probability that the tumor will disappear prior to surgery, signaling a much better outcome and survival. The study will also measure how much chemotherapy lowers red and white blood cell levels (myelosuppression) to assess whether trilaciclib reduces any of these negative side effects, which have a significant impact on patient care and quality of life," said 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. "As with other arms, the I-SPY 2 TRIAL, has the ability to evaluate the drug across an array of biomarker signatures to learn the chance of how it will benefit patients and predict success in a confirmatory phase 3 trial."

"The I-SPY 2 program is recognized as a leading breast cancer research initiative, and we are excited about the opportunity to evaluate the potential of trilaciclib to improve outcomes for a range of breast cancer subtypes. In our Phase 2 trial of women with triple negative breast cancer, patients who received trilaciclib plus chemotherapy showed significant improvement in overall survival, and reductions in the rate of red blood cell transfusions versus patients treated with chemotherapy alone," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D at G1. "The I-SPY 2 study will allow us to evaluate trilaciclib for the first time in combination with several broadly-used chemotherapy classes. It will provide important data regarding which patients may benefit from treatment with trilaciclib and inform our future development plans."

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 II/III). G1 Therapeutics will provide funding and trilaciclib and Quantum Leap will be responsible for running the trial.

Trilaciclib will be evaluated across all high-risk, early stage breast cancer subtypes (including HR+, HER2+ and triple negative breast cancer). All patients will receive standard neoadjuvant treatment, including chemotherapy (and anti-HER2 Mab for HER2+ disease) prior to surgical resection of breast tissue. Patients in two arms of the study will also receive an anti-PD-1 immunotherapy in combination with paclitaxel prior to surgery. Biomarker data to evaluate the impact of trilaciclib on the tumor immune microenvironment, as well as pre-specified endpoints to evaluate anti-tumor efficacy and myelopreservation will be collected.

Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In 2020, the company plans to initiate a Phase 3 clinical trial in colorectal cancer and begin a neoadjuvant trial in breast cancer as part of the I-SPY 2 TRIAL.

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