On May 23, 2016 Medivation, Inc. (NASDAQ: MDVN) reportedd that the talazoparib-containing arm of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) has been activated (Press release, Medivation, MAY 23, 2016, View Source [SID:1234512693]). I-SPY 2, sponsored by the QuantumLeap Healthcare Collaborative, combines a personalized medicine approach and novel trial design to study investigational treatments in the neoadjuvant setting and is being conducted by a consortium consisting of the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), pharmaceutical and biotech companies, leading academic medical centers and patient advocates.

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"The I-SPY 2 TRIAL is designed to rapidly test promising agents to reduce the cost, time and number of patients needed to bring new therapies to breast cancer patients who urgently need new treatment options," said Laura J. Esserman, M.D., 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. "We are very excited to initiate a new trial arm of talazoparib that is designed to optimize our understanding of this investigational drug and avoid some of the complications of paclitaxel, which is part of the current standard treatment. We are building on what we know of the PARP-inhibitor drug class and looking for ways to maximize benefit and minimize toxicity, which is what all women want."

The I-SPY 2 TRIAL is a Phase II, randomized, controlled, multi-center trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III). The trial employs an adaptive design, matching experimental therapies with patients based on the use of biomarkers, investigating whether new therapies can be added to standard chemotherapy or whether they may replace certain components of standard chemotherapy in the neoadjuvant setting. Therapies that are found effective can move onto a more focused Phase III registration trial.

"We are delighted that the combination of talazoparib and irinotecan was chosen to be evaluated in this innovative trial design seeking to replace components of standard chemotherapy with more targeted, potentially less toxic agents," said Amy Peterson, M.D., Vice President, Clinical Research, Medivation. "This trial will allow us to gather important information about the activity and tolerability of this combination in a breast cancer patient population that goes beyond germline BRCA1/2 carriers and is an example of Medivation’s commitment to rapidly and efficiently bring impactful medicines to patients in need."

The talazoparib arm of the I-SPY 2 TRIAL will enroll up to 75 patients with HER-2 negative breast cancer. Patients will be treated initially with talazoparib daily and irinotecan every two weeks for 12 weeks followed by treatment with doxorubicin and cyclophosphamide. Patients in the comparator arm will receive standard paclitaxel therapy followed by doxorubicin and cyclophosphamide treatment. The primary endpoint of the trial is pathologic complete response (pCR), defined as the absence of clinical and pathological evidence of invasive tumor in breast or lymph nodes.

For more information about the I-SPY 2 TRIAL, visit www.clinicaltrials.gov, trial identifier NCT01042379.

About Talazoparib

Talazoparib is a potent and specific inhibitor of PARP 1 and 2(i) that is being developed by Medivation for the treatment of selected solid tumors. In pre-clinical studies, talazoparib has shown single-agent anti-tumor activity, as well as synergy in combination with lowered doses of DNA-damaging agents, due to its dual mechanisms of cytotoxicity, PARP trapping, and inhibition of PARP enzyme activity. Trapping of PARP on DNA impairs DNA replication resulting in tumor cell death. Talazoparib currently is in Phase III development for patients with locally advanced and/or metastatic breast cancer who harbor a germline BRCA1/2 mutation.