Daiichi Sankyo Company, Limited and QuantumLeap Healthcare Collaborative announced that a new treatment arm of the I-SPY2 TRIAL will include patritumab, an investigational anti-HER3 monoclonal antibody.

The I-SPY 2 TRIAL, sponsored by QuantumLeap Healthcare Collaborative (QLHC), is a standing phase 2 randomized, controlled, multicenter study with an innovative adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, locally-advanced breast cancer (Stage II/III). Patritumab in combination with standard trastuzumab (anti-HER2 monoclonal antibody) and paclitaxel (chemotherapy) treatment will be compared to standard therapy alone in the new treatment arm. Women with HER2+ breast cancer will be randomized to one of the treatment arms and receive treatment for 12 weeks prior to undergoing surgery to remove the breast tumor.

“The evaluation of patritumab in I-SPY 2 will inform our understanding of how agents with unique mechanisms of action, like HER3 inhibition, can combine with proven HER2 antagonists,” said Melissa C. Paoloni, DVM, DACVIM-O, Executive Director of Clinical Activities, QuantumLeap Healthcare Collaborative, Sponsor of the I-SPY 2 TRIAL. “The results will help enhance the understanding of the treatment for patients with HER2-positive disease.”

“Research suggests that the combination of a HER3 inhibitor with other inhibitors of HER family receptors may be a promising approach in treating breast cancer,” said Dale E. Shuster, PhD, Executive Director, Clinical Development, Oncology, Daiichi Sankyo. “We are excited about the inclusion of patritumab in I-SPY 2 as this study is a prime example of how a unique scientific collaboration can aid in the evaluation of promising investigational agents for patients with unmet needs.”

The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 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 3 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 3 trial) and rapid evaluation allow the trial to identify the right drug for the right patient in the most expeditious fashion.

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.

Patritumab is an investigational fully human monoclonal antibody that inhibits HER3, a unique member of the HER family that is abnormally activated in several types of cancer. To stimulate growth of a cancer cell, the HER3 receptor binds (dimerizes) with another HER family receptor such as EGFR or HER2. Preclinical evidence suggests that the combination of a HER3 inhibitor with other inhibitors of HER family receptors may be a promising therapeutic approach in treating certain cancers. In addition to inclusion in the I-SPY 2 TRIAL, a phase 2 study evaluating patritumab in previously-untreated recurrent or metastatic head and neck cancer is ongoing and enrolling patients.

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.