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The Cancer MoonShot 2020 program brings together stakeholders from pharma, community and academic oncology, as well as government and scientific communities in an effort to accelerate the potential of combination immunotherapy as the next-generation standard of care in cancer patients.
In 2016, more than 1.6 million new cases of cancer will be diagnosed and cancer will kill an estimated 600,000 Americans. The Agency for Healthcare Research and Quality estimates that the total cost for cancer care in the United States in 2011 was $88.7 billion. Fifty percent of this cost was for hospital outpatient or doctor office visits, 35% was for inpatient hospital stays, and 11% was for prescription drugs.
“The truth is, cancer is still a mystery; no two cancers are alike, making it nearly impossible to choose the best treatment path for each patient,” says Patrick Soon-Shiong, MD, founder and chief executive officer of NantWorks and founder of the Chan Soon-Shiong Institute of Molecular Medicine, located in Culver City, California. In January 2016, the billionaire launched the Cancer MoonShot 2020 Program in an effort to win the war on cancer. “When a patient is first diagnosed with cancer, they are overwhelmed with a sense of uncertainty. Our goal is to develop personalized immunotherapeutic treatment options and arm oncologists with the necessary tools to combat cancer with certainty.”
The Cancer MoonShot 2020 program brings together stakeholders from pharma, community and academic oncology, as well as government and scientific communities in an effort to accelerate the potential of combination immunotherapy as the next-generation standard of care in cancer patients. The program’s goal is to initiate randomized phase 2 trials in 20,000 patients at all stages of disease in 20 tumor types before 2020, called the Quantum Integrative Lifelong Trial (QUILT). These findings will be used to develop an effective vaccine-based immunotherapy to combat cancer by 2020.
The joint approach provides researchers with necessary testing materials and patients with more opportunities to participate through local facilities and wider insurance coverage. Oncologists receive real-time clinical trial results, and patients have hope for more positive outcomes.
SenderAccording to Leonard Sender, MD, medical director, Hyundai Cancer Institute at Children’s Hospital Orange County, Orange, California, and codirector of the Chan Soon-Shiong Institute of Molecular Medicine, “Cancer MoonShot 2020 is the first program to test the hypothesis that the immune system has the ability to defeat cancer.”
Up until recently, he says, major advances in cancer medicine involved targeted therapy, in which a particular drug targeted a change in DNA (the whole genome) and immunotherapy. These treatments were often separated in different silos. “This program will bring both concepts together; multiple partners will conduct testing in real patients, not animals, to see if the combination results in greater cures,” says Sender. “This will be done as quickly as possible by bringing in infrastructure that will allow for rapid adoption of clinical trials in light of governmental regulations.”
LeeImmunotherapy, a form of biologic therapy, is a type of cancer treatment designed to boost the body's natural defenses to fight cancer. “We are using lower-dose chemotherapies in a way that the immune response is maintained,” says John Lee, MD, cancer center director, Chan Soon-Shiong Institute of Molecular Medicine, and surgical oncologist at Sanford Health in Sioux Falls, South Dakota, which is one of the first national and regional self-insured employers to cover next-generation whole genome sequencing and proteomics for various cancers. “Treatments also include immune modulators-both antibodies and small molecule therapy-as well as a natural killer cell therapy.”
Soon-Shiong is using NantHealth, his foundation, to help fund oncology patients on clinical trials with a new molecular cancer test called GPS Cancer. The test sequences the whole DNA of 3 billion base pairs with more than 20,000 genes, as well as RNA, to identify mutated genes which express the proteins from a patient’s cancer. Testing is performed in NantOmics’ CLIA-certified laboratories that are accredited by the College of American Pathologists.
Only through this test can physicians more accurately identify which molecular alterations are present in cancer cells that will translate to abnormal proteins being produced-which are the key targets for many therapeutic interventions, Soon-Shiong says. This helps oncologists to develop personalized treatment strategies. The opportunity to identify through GPS assay which patients have "hot" (inflamed) or "cold" (immunosuppressed) tumors will play a critical role in treatment decisions and trial design in the moonshot program.
“The GPS Cancer test allows clinicians to better predict whether a cancer drug will or won’t work,” says Lee, noting that it’s very similar to how physicians perform laboratory testing to determine if an antibiotic for a bacterial infection will be effective.
"For the first time, we can measure proteins that denote resistance to taxanes and cisplatin ... standard chemotherapy that has been administered in an empiric fashion,” Soon-Shiong says. “Now with GPS, information regarding chemo resistance or chemo sensitivity can be identified from the patient's tissue by GPS and a better informed decision can be made before treatment begins. The patient and doctor can now address the question: What information could be gleaned from my tissue sample that would better inform the treating physician of the probability that the treatment about to be prescribed would be effective?”
The GPS test is unique in that it measures RNA transcription and affected protein pathways downstream and has the capability of profiling the inflamed status of the tumor. “In this era of immunotherapy, knowing whether the tumor is ‘hot’ or ‘cold’ has huge outcome implications," Soon-Shiong says.
As part of the initiative, Soon-Shiong formed clinical working groups in specific cancer specialties, including the Melanoma and Sarcoma Working Group, Head and Neck Cancer Working Group, Breast Cancer Working Group, and Radiation and Immuno-Oncology Working Group. “We will collect data from scientists and clinicians in both academic and community settings,” says Sender, a founding member of Cancer MoonShot 2020’s National Pediatrics Consortium. “We want to learn about experts’ ideas for treating specific cancers and evaluate all of the science that is known about these cancers so we can start creating our first clinical protocols."
Another goal is to find treatments for solid tumor cancers that don’t fall into the top 10 types of cancers and pediatric cancers that haven’t been successfully treated before. These include uncommon cancers that don’t typically have clinical trials such as head and neck cancer along with melanoma and sarcoma, says Lee, a leader of the Head and Neck Working Group and a member of the Radiation and Immuno-Oncology Working Group.
Test results for certain patients will be obtainable within 21 days, and oftentimes within seven days. By using a HIPAA-compliant app, called the GPS genome browser, physicians and study investigators can access report summaries. “No one on the market today has that level of sophistication,” Sender says. The Cancer MoonShot 2020 program can work with both academic and community-based cancer centers, which is important given that 85% of cancer patients are treated at community cancer hospitals.
To date, more than 300 individuals with cancer have had their testing completed. Fifteen QUILT clinical trials have opened as of September 2016. “Hopefully, we will have sequenced 5,000 patients by the end of this year,” Lee says. “I think we can make it if we ramp things up a bit. We’ve had more enrollment as the year progresses. Oncology patients are seeking out newer testing methods and are looking for newer therapies that use their body’s own immune responses to fight off cancer. By using less toxic treatments, patients experience less sickness and may not lose their hair.”
Sender adds: “Due to the bureaucracy and design of clinical trials, it can take a long time to get new ideas implemented and clinically tested. With this initiative we are hoping to complete what normally takes 10 years in five years.”
Another achievement is the formation of The National Pediatric Consortium, formed in February 2016. The consortium is focused on offering combined immunotherapy as the next-generation standard of cancer care to children. Ten founding members spanning major cities nationwide are participating in a national data sharing infrastructure to accelerate clinical development of next-generation immunotherapy. For example, as a physician and scientist whose practice and laboratory specializes in cancer caused by human papillomavirus, Lee will facilitate collaboration between Sanford Health and the Chan Soon-Shiong Institute of Molecular Medicine to advance cancer care and increase immunotherapy clinical trials available at Sanford.
In addition, the first clinical trial milestone was also achieved in January when an immunotherapy trial demonstrated encouraging survival rates in patients with end-stage metastatic colorectal cancer who were not responsive to standard therapy. More than 30% of patients who failed all standard chemotherapy and antibody therapy are still alive after neo-epitope immunotherapy ensituximab. The longest current survivor was treated more than two years ago.
“Ultimately, the aim of the program is to win the war on cancer-to get to a point in the very near future when cancer is managed the same way as other chronic disease, such as diabetes or asthma,” Soon-Shiong says.
“When we can finally stop administering toxic therapies, such as chemotherapy and radiation which decimate the immune system, and instead, rally the full power of the immune system and the body’s natural killer cells to fight off the cancer the way they were designed to do, patients will not only survive their diagnosis, but live-even thrive-with cancer,” Soon-Shiong concludes.
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.