Dr Patrick Soon-Shiong's Dream Team: The National Immunotherapy Coalition

A collaboration between the who’s who of healthcare was announced on January 12, 2016, at the annual JP Morgan Healthcare Conference. With the hope of accelerating the development path of next generation immunotherapy in oncology, The National Immunotherapy Coalition has coalesced leaders from large pharma (Celgene and Amgen), biotech (NantWorks, NantKwest, Etubics, Altor Bioscience, and Precision Biologics), academic cancer centers, community oncologists, and the health plan Independence Blue Cross. This coalition forms the basis of The Cancer MoonShot 2020, with a robust backing from vice president Joe Biden.

Following are important features of the program:

• Nation’s first insurance coverage of next generation whole genome sequencing and proteomic diagnostic platform in cancer patients
• Next generation sequencing and precision medicine evolving from research to the clinical trial and cancer care setting
• Coalition to design, initiate, and complete randomized clinical trials at all stages of cancer in up to 20 tumor types in as many as 20,000 patients in multiple phase 1 to 3 trials by year 2020
• Beneficiaries and patients will undergo next-generation molecular sequencing and gain access to over 60 novel and approved molecules to be tested as immunotherapy combinations in 20,000 cancer patients with cancer across all tumor types: The QUILT Program

To further discuss this venture, Patrick Soon-Shiong, MD, founder and CEO of NantWorks, and the brain behind this entire operation, invited Dan Hilferty, president and CEO of the Independence Health group (parent company of Independence Blue Cross); and Paul Black, CEO, Allscripts Healthcare Solutions Inc, to participate on a panel at the Healthcare Conference on January 13, 2016.

“The president mentioned the moonshot in his State of the Union speech, which has put us on the stage and in the news,” said Soon-Shiong. “The opportunity to change healthcare forever, in the face of immunotherapy use, is upon us. It’s taken us 15 years to get here.” Explaining that our body has the innate capacity to immunize itself against infections as well as abnormal growth, he added, “I have personally struggled with the fact that we destroy our immune system with chemotherapy, and then boost the immune system with checkpoint inhibitors.”

He acknowledged the fact that this has been the dogma due to multiple reasons that include marketing plans, payments to be made, business decisions, etc. “We know that when you create a blockbuster, it treats only 20% of those who receive it…this is well known.” When a physician prescribes this treatment, Soon-Shiong added, he goes in blindly without knowing whether you fall under the responsive 20% or the unresponsive 80% of patients.

Another important aspect is the dearth of patient participation in cancer clinical trials. Most trials are primarily conducted in the academic center setting, not in the community; community doctors often do not send their patients to these academic centers because of the fear of losing them. So there exists a disconnect at every stage. “That is why only 4% of cancer patients are enrolled in clinical trials. But I firmly believe in measurement to improve health outcomes. We have to understand each of the 3 billion base pairs in every genome, which is an expensive proposition.” That’s where the health plans come in. “It will be paid for by pulling in the health plan,” he said.

Hilferty chimed in, saying, “As part of the Moonshot, we are working closely with the team.” With heavy accolades to Soon-Shiong, Hilferty said he was the only individual who could pull together the financers, the pharmaceutical industry, the scientific heavyweights, the regulators, and the Government for the MoonShot project.

Explaining his company’s decision to approve whole genomic testing for their beneficiaries being treated for cancer, he said, “We serve 3 million people in 5 counties in the Philadelphia region. It’s a small pool in the hundreds, a small pool but it’s a start. We want to prove that working together with whole genome testing will improve the quality of care and outcomes as well as the service we deliver. This can serve an example for care providers across the country. With outcome-based practice of medicine, we can show that we can improve outcomes and reduce costs as well. From an insurance point of view, this is the future.” Hilferty said that they will be working to convince other insurers to get on board as well.

Black had similar praise for Soon-Shiong, for his vision and his leadership abilities in bringing competitors together to collaborate on this project. “We have faith that the monstrous amount of data resulting from the sequencing can be applied and translated by community oncologists even in rural areas to improve outcomes.” Black emphasized the need to connect individuals with their data, and their information. “We are thrilled to be a part of this project,” he said.

According to Soon-Shiong, the platform can help reduce the toxicities and avoid unnecessary treatment with chemotherapy agents. Introducing the concept of “targeted chemotherapy,” he said clinical trials will be designed conduct a micro laser dissection on tumor samples and measure resistance patterns of the tumor to different chemotherapy agents. “We can measure the resistance factor before treating patients with the drug…similar to how we measure antibiotic resistance in patients before starting them on an antibiotic.” This can put an end to the trial-and-error empiric treatment.

“We also need to empower the patient with his medical record…think about a patient controlling his own medical record and giving the doctor the privilege to access it,” said Soon-Shiong.

“We want to create a predictive learning model, which makes real-time analysis vital. But analyzing and computing this huge amount of data in real-time requires enormous computing capacity,” Soon-Shiong explained. He said they plan to use the fibre optic cable that was earlier used by scientists working on the Large Hadron Collider, which has the capacity to compute data at the rate of 10 Gb/sec. “This is what we mean by analyzing tumor data in real time. We are not talking about retrospective claims data; its tumor data that we now have the capability to analyze in 47 seconds.”

Sharing his experience meeting vice president Biden and his staffers recently, he said, “We explained this science to them and we wanted to help them understand this problem and ask them for their support—regulatory and otherwise. Robert Califf and Janet Woodcocok were there as well.”

“The concept of immunotherapy as the backbone is the only way to fight this disease. My only concern is with wiping off the immune system,” Soon-Shiong said, introducing the QUILT (QUantitative Integrative Lifelong Trial) program as a part of the Cancer MoonShot 2020. QUILT is designed to harness and orchestrate all the elements of the immune system by testing novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy and immunomodulators—including check point inhibitors—in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic analysis, with the goal of achieving durable, long-lasting remission for patients with cancer.