Quantum Leap Healthcare Collaborative

Press Release

Widely hailed as the future of phase II drug development, the adaptive I-SPY2 platform trial has set a new benchmark for efficiency, through innovation in trial design and clinical operations.

Keytruda, talazoparib join I-SPY 2

QuantumLeap Healthcare Collaborative Announces Inclusion of MERCK’s KEYTRUDA (pembrolizumab) and MEDIVATION’s Talazoparib PARP-Inhibitor for I-SPY 2 TRIAL in Breast Cancer

SAN FRANCISCO, CA—March 21, 2016 – QuantumLeap Healthcare Collaborative today announced that the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) has opened a new treatment arm that includes Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). Also entering the I-SPY 2 TRIAL in the next few months will be Medivation’s (Nasdaq: MDVN) potent, investigational PARP Inhibitor talazoparib (MDV3800). The I-SPY 2 Trial is sponsored by QuantumLeap Healthcare Collaborative (QLHC), a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions.

The I-SPY 2 TRIAL (NCT01042379) is a standing Phase II randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient subgroups. The trial is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical and biotech companies, leading academic medical centers, and patient advocates under its umbrella.

I-SPY 2 employs a unique adaptive trial design to match experimental therapies with patients, while testing whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery). The innovative adaptive design utilizes biological markers (biomarkers) from each woman to assign her to a particular investigational drug. The trial learns as it goes, as each patient’s response to a particular drug informs how the next patient will be assigned to a treatment arm. Drugs with a strong efficacy threshold for a particular patient group may “graduate” to a more focused phase III drug registration trial, while drugs found to be ineffective or with significant side effects are dropped from the trial quickly. This high efficacy bar (85% likelihood of success in a 300-person phase III trial) and rapid evaluation allow the trial to identify the right drug for the right patient in the most expeditious fashion.

“The I-SPY TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting targeted and potentially less toxic treatments to patients much more quickly. The goal is to compress the timeline to get the right drugs to the right patients, and to do so more affordably. We are excited to bring MERCK’s agent, which specifically targets the tumor immune microenvironment in the neoadjuvant setting, into I-SPY where we can learn where it will be most effective,” stated Dr. Laura J. Esserman, 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.

“In addition to the knowledge we gain from KEYTRUDA, we are also very excited that Medivation’s investigational PARP inhibitor talazoparib will be offered in the I-SPY TRIAL,” added Dr. Esserman. “The activity and side effect profile of talazoparib established in multiple investigational settings merits its inclusion in the evaluation of new agents being tested in the neoadjuvant space, and we are eager to include these potent new agents in I-SPY 2.”

“At Merck, we believe that innovative clinical trial design and collaboration are key components to advancing science and helping us uncover new treatments for cancer,” said Dr. Eric Rubin, Vice President and Therapeutic Area Head, Oncology Early-Stage Development, Merck Research Laboratories. “We are pleased that KEYTRUDA is included in this important clinical study which focuses on understanding new options for patients with locally advanced breast cancer.”

“We have seen promising results with pembrolizumab for both estrogen receptor positive and triple-negative breast cancer, and we look forward to learning more about which breast cancer patients are most likely to benefit from this anti-PD-1 therapy,” stated Dr. Rita Nanda, Assistant Professor of Medicine and Associate Director of Breast Medical Oncology at University of Chicago Medicine and the lead investigator for KEYTRUDA in the I-SPY 2 TRIAL.

“We are excited that the combination of talazoparib with low-dose irinotecan will be the first regimen to be tested without the traditional paclitaxel backbone in I-SPY-2,” said Amy Peterson, M.D., Vice President, Clinical Development, Medivation. “Talazoparib, which currently is in Phase 3 for patients who harbor a germline BRCA1/2 mutation, has demonstrated pre-clinical synergy in combination with lowered doses of DNA-damaging agents due to its remarkable PARP trapping ability, as well as activity and tolerability in phase 1b. Inclusion in the I-SPY 2 clinical trial will allow us to gather further efficacy and safety data about this combination in hopes of introducing a new treatment option targeted specifically for patients with more aggressive, faster growing breast cancer.”

About QuantumLeap Healthcare Collaborative
QuantumLeap Healthcare Collaborative, a non-profit foundation, was established in 2005 as a collaboration between medical researchers at University of California at San Francisco, and Silicon Valley entrepreneurs. QuantumLeap’s mission is to accelerate transfer of high-impact research in clinical processes and systems technology into widespread adoption so that patients and physicians can benefit from the research as soon as practicable. QuantumLeap provides operational, financial and regulatory oversight to I-SPY 2 and is also the sponsor of its companion phase 3 confirmatory trial, I-SPY 3. For more information, visit: http://www.quantumleaphealth.org.

UC Disclaimer
The information stated above was prepared by MERCK, Medivation, and the QuantumLeap Healthcare Collaborative, a 501(c)(3). This information solely reflects the opinions of those entities. Nothing in this statement shall be construed to imply any support or endorsement of MERCK, Medivation, or any of its products, by The Regents of the University of California, its officers, agents and employees.

Media Contact:
Cynthia Inácio, QuantumLeap
King + Company Public Relations

Media Contact:

Karyn DiGiorgio
Quantum Leap Healthcare Collaborative