Press Releases

Data to Be Presented at 2017 ASCO Annual Meeting Include Findings in

Patients with Locally Advanced Triple-Negative (TNBC) and
Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Breast Cancers

KENILWORTH, N.J. & SAN FRANCISCO, June 5, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and QuantumLeap Healthcare Collaborative, today announced results from the Phase 2 I-SPY 2 TRIAL investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with standard therapy [paclitaxel followed by doxorubicin and cyclophosphamide (AC)] as a neoadjuvant (pre-operative) treatment for patients with locally advanced triple-negative breast cancer (TNBC) or hormone receptor-positi...

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NEW ENGLAND JOURNAL OF MEDICINE UNDERSCORES SUCCESS OF THE I-SPY 2 CLINICAL TRIAL MODEL AS PROMISING RESULTS ARE PUBLISHED FOR TWO BREAST CANCER DRUGS INVESTIGATED IN THE STUDY

See publications on www.nejm.org here:

Adaptive Randomization of Neratinib in Early Breast Cancer
Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer

Adaptive Platform Trial with Treatment in Neo-adjuvant Setting Streamlines Drug Development.

Rapid Development of New Breast Cancer Drugs Means Better Options for Women with Triple Negative and HER2+ Breast Cancer

SAN FRANCISCO, CA – July 7, 2016 –Two articles published today in the July 7, 2016 issue of the New England Journal of Medicine (NEJM) reinforce the importance of mul...

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Pre-surgery Combination Therapy Lessens Short and Long-term Toxicity and Could Mean Development of Fewer Recurrent Metastatic Breast Cancers

QuantumLeap Healthcare Collaborative is Working to Accelerate Research and Development of Better and More Cost Effective Treatments for the Most Resistant and Aggressive Forms of Breast Cancer

San Francisco, CA—April 18, 2016 — QuantumLeap Healthcare Collaborative today announced Results from the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) indicating that a neoadjuvant (presurgery) therapy combination of the antibody-drug conjugate trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) was more benefi...

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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 Collab...

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Researchers Present Data at Breast Cancer Symposium Showing MammaPrint/BluePrint Can Identify Women Who Benefit from Chemotherapy and Targeted Dual Anti-HER2 Drug Treatment Before Surgery

IRVINE, CA and AMSTERDAM, THE NETHERLANDS – Agendia’s MammaPrint® and BluePrint® tests provide new insights that may provide many more women with beneficial treatment for breast cancer before surgery, according to findings presented at the 2015 Breast Cancer Symposium.

Researchers analyzed a cohort of 889 early-stage breast cancer patients in the NBRST (“N-breast”) study who had functional molecular subtyping with the BluePrint test. The data underscored the ability of MammaPrint and BluePrint to predict the result of con...

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Researchers estimate the 20-year breast cancer-specific death rate for women diagnosed with ductal carcinoma in situ to be 3.3 percent, although the death rate is higher for women diagnosed before age 35 and for black women, according to an article published online by JAMA Oncology.

Ductal carcinoma in situ breast (DCIS) cancer, which is also referred to as stage 0 breast cancer, accounts for about 20 percent of the breast cancers detected through mammography. Some women with DCIS experience a second breast cancer (DCIS or invasive) and a small proportion of patients with DCIS ultimately die of breast cancer. However, it is not clear what factors might predict mortality after a DCIS diagnosis. Women who develop an invasive breast cancer ...

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QuantumLeap Healthcare Collaborative today announced top line results for the investigational AKT inhibitor, MK-2206, developed by Merck (known as MSD outside the United States and Canada), in the Phase II I-SPY 2 TRIAL for the neoadjuvant treatment of breast cancer.

The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or 3 breast cancer that addresses whether adding biologically targeted investigational drugs to standard chemotherapy in the neoadjuvant (pre-operative) setting is better than standard chemotherapy. The trial enrolls patients who have a high risk of relapse using up-front ...

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BERKELEY, CA, and SAN FRANCISCO, CA—December 11, 2014 – 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).

About the I-SPY 2 TrialI-SPY 2 i...

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The I-SPY 2 trial identified a neo-adjuvant regimen containing the investigational drug neratinib and standard chemotherapy to be beneficial for hormone receptor (HR)-negative, HER2-positive primary (non-metastatic) breast cancer patients, according to data presented at the AACR Annual Meeting.

“The I-SPY 2 trial is a randomised phase II clinical trial for women with newly diagnosed stage 2 breast cancer,” said John W. Park, M.D., professor of medicine at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco.

“The trial tests whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy alone, and the goal is to match investigational reg...

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The first results from the I-SPY 2 trial, which is evaluating novel agents in the neoadjuvant treatment of breast cancer, show encouraging possibilities for veliparib (ABT-888) and neratinib (PB272). The study employs a groundbreaking approach that may accelerate and influence the way that oncology drugs are tested and approved in the near future, leading researchers said during the 2013 San Antonio Breast Cancer Symposium.

The approach involves evaluating drugs in small study populations, using advanced statistical techniques that will promptly identify potentially successful cohorts. The investigators have label these drugs the “graduates,” which are then eligible to move into phase III testing, according to Hope S. Rugo, M...

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