11/9/2017 Landmark Analysis from Memorial Sloan Kettering Reveals Genomic Tumor Sequence of More Than 10,000 Cancer

er Patients Using MSK-IMPA…

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Pressroom / Press Releases

Landmark Analysis from Memorial Sloan Kettering

Reveals Genomic Tumor Sequence of More Than 10,000
Cancer Patients Using MSK-IMPACT™
New York, NY,
Monday, May 8, 2017

Memorial Sloan Kettering (MSK) has reached a major milestone in bringing personalized
treatments to more cancer patients. Michael Berger, PhD, Ahmet Zehir, PhD, and colleagues
have reported an in-depth analysis of the first 10,336 patients whose tumors were submitted for
clinical genomic sequencing by MSK-IMPACT™, a powerful diagnostic test developed at MSK to
provide detailed genetic information about a patient’s cancer. Their landmark work, published in
Nature Medicine, analyzes the central findings in one of the only studies that has evaluated the
clinical impact of real-time large-scale tumor sequencing in patients with metastatic cancer.

Building on MSK’s rich history of innovation, a team of nearly 100 MSK researchers reported the
results for the first 10,945 tumors that underwent clinical genomic sequencing through MSK-
IMPACT™. MSK-IMPACT™ (Integrated Mutation Profiling of Actionable Cancer Targets) detects
gene mutations and other critical genetic aberrations in both rare and common cancers. The
study found that nearly 37 percent of patients who had their tumors sequenced through MSK-
IMPACT™ had at least one actionable mutation, meaning that drugs to target these mutations
were available either in a clinical trial or as part of the standard of care. Additional patients
harbored mutation profiles suggesting they were more likely to respond to immunotherapy
treatment. In addition, the breadth and depth of MSK-IMPACT™ allowed the researchers to
detect important genomic alterations that would have been missed by other approaches.

“This study represents the culmination of a major effort and investment in implementing large-
scale clinical sequencing of patients at MSK,” says Dr. Berger, Associate Director of the Marie-
Josée and Henry R. Kravis Center for Molecular Oncology and senior author of the study. “Now
that we have sequenced more than 10,000 patients, we have assembled a data set with
enormous opportunities for data mining and discovery. The first 10,000 patients were a big
milestone for us, and this paper describes how the tumor sequencing data contributed to these
patients’ care.”

Implications for Patients

Based on the study results, 11 percent of patients were able to participate in clinical trials of
treatments that directly targeted the genetic alterations in their tumors. MSK-IMPACT™ has
helped doctors accelerate the entry of patients into cancer clinical trials, which are crucial to test

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new therapies.

Collaboration and Data Sharing with Colleagues

All of the data collected through MSK-IMPACT™ testing is being made available to the larger
scientific community through a database developed at MSK called the cBioPortal. Patients’
identifying information is removed, but basic clinical data are included, allowing researchers at
MSK and beyond to study the connections between particular genomic alterations and the
patients’ responses to therapy and their eventual outcomes. In addition to having a leading role
in data-sharing initiatives, such as the American Association for Cancer Research’s Project
GENIE, MSK has created a number of its own initiatives aimed at increasing DNA sequencing in
minority populations and for patients around the world.

MSK also launched the MSK Cancer Alliance in 2014, aimed at improving the quality of care and
outcomes for people with cancer in community settings. These are just a few examples of the
work being done to break down the silos, increase collaboration and information exchange, and
ultimately expand accessibility to new precision treatments. MSK’s exceptionally powerful and
seamless integration of clinical and scientific teams makes it uniquely situated to help design the
future of precision oncology.

Enrolling Patients in Genomically Informed Clinical Trials

MSK patients increasingly have the opportunity to participate in clinical trials — including basket
trials, which target the mutations that drive tumors regardless of where the cancer originated in
the body. By sequencing patients’ tumors with MSK-IMPACT™, doctors can accelerate the
accrual of patients, which allows for faster enrollment in clinical trials and faster analysis of the
results and potentially leads to earlier approval of new therapies.

As evidenced by the establishment of the CMO and the vision of MSK’s Physician-in-Chief, José
Baselga, MD, PhD, MSK leadership saw the promise of precision oncology early on and
committed to realizing its ability to create better treatment options for all people with cancer.
With more than 800 clinical trials currently open, MSK has a strong clinical trial infrastructure.
After launching a comprehensive survey and determining that only 4 percent of all patients
enroll in clinical trials for cancer each year, the MSK community is actively working to expand
enrollment in clinical trials.

“Genomic sequencing is allowing scientists to glean new insights into why some patients
respond very well to drugs while others do not. By focusing on so-called exceptional responders,
it’s possible to uncover new insights connecting particular gene mutations to drug responses,”
says Dr. Baselga, also a study author. “Less than 5 percent of adults with cancer in the United
States enroll in clinical trials. This means that many trials take longer to perform due to slow
patient accrual, which in turn means it takes longer to test a drug’s efficacy. MSK-IMPACT™ is
designed to address this problem.”

The MSK-IMPACT™ Team

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MSK-IMPACT™ sequencing has been approved by the New York State Department of Health as a
clinical test and is performed in the clinical laboratories of the MSK Molecular Diagnostics
Service, led by Marc Ladanyi, MD, who played a key role in implementing MSK-IMPACT™
sequencing clinically and who oversees this effort together with Maria Arcila, MD. In MSK-
IMPACT™, both the tumor sample and a normal sample from the same patient are sequenced in
each case.

This is done to identify genetic differences between the two in order to pinpoint the cancer-
causing mutations, but it also provides valuable information about inherited mutations that may
increase the risk for cancer development. Detecting inherited mutations can allow doctors to
more closely monitor the organs in which cancer may arise, and it offers the opportunity for the
patient’s family to be tested for the mutation and screened for earlier cancer detection if they
also carry the same mutation.

The MSK-IMPACT™ team includes molecular pathologists, clinical bioinformaticians, genomic

technology scientists, genomic variant curators, and highly specialized clinical technologists
working together to ensure that the most accurate and clinically useful information is obtained
through this clinical tumor sequencing program, possibly the largest of its kind anywhere.

“As we pass this important MSK-IMPACT™ milestone, I think we are well on our way to
establishing a new paradigm for cancer care,” says Dr. Ladanyi, also a study author. “As part of
the standard initial assessment of cancer patients, we can now not only identify the exact type
of cancer and how far it has spread but also determine the mutations that drive the cancer cells
to divide. Knowing the genetic makeup of the patient’s cancer now helps us select the drugs
most likely to be effective in that patient.”

Journalists may contact the Department of Public Affairs for

more information.
Telephone: 212-639-3573
Email: mediastaff@mskcc.org

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