ASH Clinical News June 2016 | Page 40

FEATURE Cancer Moonshot our patients. We can learn from our solid tumor colleagues and they, in turn, can learn from us.” Dr. Singer said that determining the best way to share data is a challenging problem in cancer today, particularly due to the large datasets clinical trials are generating. “To truly learn from these data, they need to be complemented by patient annotation.” “That’s why the Moonshot Initiative is so important,” Dr. Anderson added. “Hopefully, the Vice President is setting an example that will inspire people to work in partnership on a scale that we simply haven’t seen previously.” The Promise of Immunotherapy The Moonshot Initiative seems to be marked by its macro- and micro-level views of cancer. “On the one hand, the Moonshot Initiative is exploring big data initiatives to define the heterogeneity of disease, but, just as importantly, it is also exploring personalized immunotherapies – the most promising area in cancer management today,” Dr. Anderson said. “It’s a very exciting time.” The Moonshot Initiative will take a deep dive into immune system–based therapies, which have shown success in melanoma, leukemia, and lymphoma. According to the White House, “this approach is ripe for further exploration in a wider range of cancers.” “The immune system is selective, potent, and very adaptable,” Dr. Anderson explained. “It may be able to overcome the evolution and changes in cancer cells that ultimately lead to resistance and relapse of disease.” As part of the Moonshot Initiative, researchers are also developing vaccines that could prevent cancer from ever developing or that induce an immune response earlier in the disease course – based on the success of vaccines for cervical cancer and other cancers caused by human papillomavirus. According to the White House, funding will go toward “speeding the development, evaluation, and optimization of safe cancer vaccines targeting unique features of individual cancers.” “The concept is th at these approaches vary and have unique mechanisms of action, but the future promise lies in combining these therapies,” Dr. Anderson said. If researchers are able to achieve a memory immune response against a patient’s own cancer through combination therapies, someday it may be possible that a patient never develops active cancer, he explained. Targeting the Genome Although the Moonshot Initiative is still taking shape, the National Institutes of Health (NIH) and the White House have already announced progress in increasing our understanding of the genetic changes that occur within the cancer cell. The NIH is leading the Precision Medicine Initiative (PMI), a research effort to use genomics and big data analytics to develop personalized treatments for many diseases, including cancers. The largest component of this Initiative is the PMI Cohort Program, a long-term health study that will examine genetics, lifestyle factors, and health in an effort to propel precision medicine and identify cancer cures. In February, the program began accepting volunteers. The NIH wants to enroll the first cohort of 79,000 participants into the precision medicine database by the end of 2016, with a projected total enrollment of 1 million participants by 2019. To spur enrollment, the NIH provided funding to Vanderbilt University in Nashville, Tennessee, to perform a pilot study of direct recruitment initiatives, including a participant website and phone line.8 The NIH also pledged to work with federally funded community health centers to encourage cohort volunteers from underserved populations. “For most of history, medicine has been based on trying to identify what works for the average person,” NIH Director Dr. Collins said in a press conference discussing the program. “We’re all different. This one-size-fits-all approach is far from optimal.” The goal of the PMI Cohort Program and recruitment initiatives is to “empower any person, anywhere in the United States, to raise their hand and volunteer to participate.” “The PMI focuses on implementing what we have already learned about cancer genomics to clinical trials,” Dr. Singer added. “The PMI and the Blue Ribbon Panel share complementary agendas and, hopefully, both efforts would be moved under a common umbrella down the line.” Looking to the Future The White House has set forth a bold goal – eliminating an indiscriminant disease that is estimated to kill 600,000 Americans this year.1 So, with what we know about the Initiative so far, will the moonshot lead to more hits or misses? “What the NCI has learned in the last decade is that cancer is diverse and is driven by mutations that continue to accumulate as cancer grows,” Dr. Singer said. Some of the mutations are common to many cancers, but others are unique. In other words, one size does not fit all. While strategies that target the immune system may be more universally applicable and certain approaches target commonalities found within multiple forms of cancers, individual treatment strategies will still be necessary to effectively treat each type of cancer, she added. “We are going to have a lot of different approaches, but the more we learn, the more we can develop those targeted therapies.” “The solutions are not going to be simple,” Dr. Anderson said. “We will likely look to targeted therapies in combination with immunotherapeutic approaches admin- istered early in the disease course – when the potential for the treatment’s effect is greatest.” There are still many questions about the future of the Moonshot Initiative – which priorities will be identified and adopted, for one – but those involved in the process say the hematology/oncology community won’t have to wait long before more specifics are known. A clearer picture will start to emerge by this fall, when the Blue Ribbon Panel will present its top priorities and recommendations to the Task Force and National Cancer Advisory Board. The Task Force is expected to deliver its full report, including the top research priorities, to President Obama in December. “This is moving fast,” Dr. Mayer said. “I think we have a very strong panel bringing different aspects of cancer and cancer care to the table, but we all recognize our charge is really to look at the whole picture.”—By Jill Sederstrom ● REFERENCES 1. The White House. Fact Sheet: Investing in the National Cancer Moonshot. Accessed May 4, 2016 from https://www.whitehouse. gov/the-press-office/2016/02/01/fact-sheet-investing-nationalcancer-moonshot. 2. The White House. Memorandum: White House Cancer Moonshot Task Force. Accessed May 4, 2016 from https://www.whitehouse.gov/ the-press-office/2016/01/28/memorandum-white-house-cancermoonshot-task-force. 3. National Cancer Institute. Blue Ribbon Panel announced to help guide Vice President Biden’s National Cancer Moonshot Initiative. Accessed May 4, 2016 from http://www.cancer.gov/news-events/pressreleases/2016/blue-ribbon-panel-announced. 4. Friends of Cancer Research. “Pink Sheet - FDA Oncology Center of Excellence Coming, Moonshot or Not.” Accessed May 5, 2016 from http://www.focr.org/news/pink-sheet-fda-oncology-centerexcellence-coming-moonshot-or-not. 5. Carter AJR, Nguyen CN. A comparison of cancer burden and research spending reveals discrepancies in the distribution of research funding. BMC Public Health. 2012;12:526. 6. “Sustaining the New ‘Golden Age’ of Medical Research.” Panel discussion at the Milken Institute Global Conference, May 2, 2016; Los Angeles, California. 7. “Highlights 2016: Vision for the Future.” Plenary session at the American Association of Cancer Research Annual Meeting. April 20, 2016; New Orleans, Louisiana. 8. National Institutes of Health. “Preparing to Launch the Precision Medicine Initiative Cohort Program.” Accessed May 6, 2016 from https:// www.nih.gov/about-nih/who-we-are/nih-director/statements/ preparing-launch-precision-medicine-initiative-cohort-program. ASH Offers Expertise to Help With Initiative Pictured L to R: Suzanne Leous, ASH staff; Kenneth Anderson, MD, president-elect of ASH; Greg Simon, executive director of the Cancer Moonshot Initiative; Martin Tallman, MD, and Tracy Roades, ASH staff. 38 ASH Clinical News Leaders of the Cancer Moonshot Initiative are asking for public comments, and ASH has made sure hematology’s priorities have been heard. In April, ASH representatives met with Executive Director Greg Simon at the White House to share ASH’s scientific recommendations for the Initiative. “Hematologists are pioneers in several fields that are revolutionizing cancer research, including immunotherapy, cell therapy, and genome sequencing – areas of study that are now showing great promise in treating solid tumors in addition to blood cancers,” ASH President Charles S. Abrams, MD, said in a statement supporting the Initiative. Commenting on the meeting, Kenneth Anderson, MD, said that ASH was well received. “Mr. Simon could not have been nicer and more receptive and spent several hours with us and appreciated the value that ASH can bring to the Moonshot effort.” Prior to the meeting, an ASH task force on precision medicine was charged with creating a series of recommended action items for the Moonshot Initiative. For a full list of ASH’s recommendations, visit www.hematology.org/Research/Recommendations/ Moonshot-Initiative. June 2016