Innovative Trials Produce Promising Breast Cancer Drugs

Excerpt:

“An innovative set of clinical trials have identified two drugs that could provide a fighting chance for women with advanced breast cancer.

“The drugs, neratinib and veliparib, both appear effective in helping women diagnosed with stage 2 or 3 , researchers report.

“These are the first two drugs to come out of the I-SPY clinical , a research effort intended to streamline  testing by better guiding treatments to those who would most benefit from them, said one of the study authors, Dr. Laura Esserman. She is director of breast cancer care at the University of California, San Francisco’s Comprehensive Cancer Center.”

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Neoadjuvant T-DM1/Pertuzumab Combo Boosts pCR in HER2+ Breast Cancer

Excerpt:

“Neoadjuvant ado-trastuzumab emtansine (T-DM1; Kadcyla) in combination with pertuzumab (Perjeta) improved pathologic complete response (pCR) compared with standard of care in patients with advanced HER2-positive breast cancer, according to recently reported data from the adaptively randomized I-SPY 2 trial.

“Of the 249 patients with HER2-positive disease included in the I-SPY 2 trial, 54% of those who received T-DM1/pertuzumab experienced a pCR compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“These findings suggest that T-DM1 may ultimately increase survival in these patients, says lead study author Angela M. DeMichele, MD, professor of Medicine and Epidemiology at the University of Pennsylvania.”

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​​A Presurgery Combination Therapy May Improve Outcomes for Women With HER2-positive Breast Cancer

Excerpt:

“Results from the I-SPY 2 TRIAL show that a neoadjuvant (presurgery) therapy combination of the antibody-drug conjugate trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) was more beneficial than paclitaxel plus trastuzumab for women with HER2-positive invasive breast cancer, according to research presented here at the AACR Annual Meeting 2016, April 16-20.

“In this portion of the I-SPY2 TRIAL, the investigators tested if T-DM1 plus pertuzumab could bring a substantially greater proportion of patients to the primary endpoint of pathological complete response [pCR] compared with paclitaxel plus trastuzumab. They also examined whether this combination could meet that goal without the need for patients to receive paclitaxel. pCR is an outcome in which, following neoadjuvant therapy, no residual invasive cancer is detected in the breast tissue and lymph nodes removed during surgery.”

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Plexxikon and QuantumLeap Healthcare Collaborative Announce Selection of PLX3397 for I-SPY 2 TRIAL in Breast Cancer

The gist: A new drug called PLX3397 will now be available through the innovative I-SPY 2 clinical trial, which uses molecular testing to match breast cancer patients to the pre-surgery treatments most likely to work for them. The trial is open for participation by women with newly diagnosed, locally advanced breast cancer.

“Plexxikon Inc., a member of Daiichi Sankyo Group, and QuantumLeap Healthcare Collaborative today announced that Plexxikon’s drug candidate, PLX3397, has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (minimum of Stage 2) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery).

“I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The 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 employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (‘biomarkers’) from individual patients’ tumors are used to screen promising new treatments, identifying which therapies are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may ‘graduate’ from I-SPY. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.”