Cancer MoonShot 2020 Proposes a Collaborative Precision Cancer Care Model

A collaboration among the who’s who of healthcare was announced on Monday, January 12, 2016, at the annual JP Morgan Healthcare Conference. Seeking to accelerate the development of next-generation immunotherapy in oncology, The National Immunotherapy Coalition (NIC) 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 Cancer MoonShot 2020, which boasts the following key attributes:

• The 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 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 under the QUantitative Integrative Lifelong Trial (QUILT) Program

To further discuss this venture, Patrick Soon-Shiong, MD, founder and CEO of NantWorks, and the brains 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 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 dogma is influenced by factors beyond research, such as marketing plans and business decisions. “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 of the failure to treat is the dearth of patient participation in cancer clinical trials. Most trials are primarily conducted in academic centers, not in the community; community doctors often do not send their patients to these academic centers because of fear of losing them. “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 plans,” he said.

Compliments and Controversy

Hilferty acknowledged being a part of the group, “As part of MoonShot, we are working closely with the team.” With heavy accolades for 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 this project.

There is, however, some controversy associated with Soon-Shiong’s claims. According to an article in The Cancer Letter¸ officials from the National Cancer Institute (NCI) and the FDA are not in partnership with NIC¹; in fact, government officials asked Soon-Shiong to remove federal agencies from the press release announcing the partnership,² the article claims.

Explaining his company’s decision to approve whole genomic testing for beneficiaries receiving treatment for cancer, Hilferty added, “We serve 3 million people in 5 counties in the Philadelphia region. [The trials] will include a small pool numbering in the hundreds, 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 in marshalling competitors 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 said, emphasizing the need to connect individuals with their data and their information. “We are thrilled to be a part of this project,” he added.

According to Soon-Shiong, the platform they plan to develop can also help reduce the toxicities and avoid unnecessary treatment with chemotherapy agents. Introducing the concept of “targeted chemotherapy,” he said clinical trials will be designed to 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 records…think about a patient controlling his own medical records 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.” He said they plan to use the fiber 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; it’s tumor data that we now have the capability to analyze in 47 seconds.”

Sharing his experience of meeting Vice President Biden and his staffers recently, Soon-Shiong said, “We explained this science to them, and we wanted to help them understand the problem and ask them for their support—regulatory and otherwise. Robert Califf and Janet Woodcock were there as well.”

White House insiders have denied official support of the project. According to The Cancer Letter,¹ although Biden and his staff have participated in listening sessions with Soon-Shiong, neither the vice president nor any federal agencies are involved with the MoonShot program. In fact, Francis Collins, MD, PhD, director of the National Institutes of Health, said that the program described by Soon-Shiong at the Healthcare Conference does not involve the NCI or the FDA.

Back to MoonShot 2020

“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 program as a part of Cancer MoonShot 2020. QUILT is designed to harness and orchestrate all the elements of the immune system (including dendritic cell, T-cell, and NK cell therapies) 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.² EBO

References

1. Ong MBH. When moonshots collide. The Cancer Letter website. http://www.cancerletter.com/articles/20160115_2. Published January 15, 2016. Accessed January 18, 2016.
2. Historic national coalition formed to accelerate next generation immunotherapy in cancer [press release]. San Francisco, CA: NantHealth; January 11, 2016. http://www.businesswire.com/news/home/20160111006094/en/Historic-National-Coalition-Formed-Accelerate-Generation-Immunotherapy.

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