This past January, ASCO published Clinical Cancer Advances 2018,1 its 13th annual report on the progress being made against cancer. The report names chimeric antigen receptor (CAR) T-cell immunotherapy as ASCO’s Advance of the Year. In 2017, the U.S. Food and Drug Administration (FDA) approved two CAR T-cell therapies: tisagenlecleucel (Kymriah) for the treatment of pediatric acute lymphoblastic leukemia (ALL) and axicabtagene ciloleucel (Yescarta) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and DLBCL arising from follicular lymphoma. Research is also underway in the use of CAR T-cell therapy in the treatment of multiple myeloma.
In addition, the report highlights other precision medicine approaches including immune checkpoint inhibitors that are impacting care for patients with cancer. According to the report, an analysis by the ASCO Center for Research and Analytics (CENTRA) estimates that immune checkpoint inhibitors could save 250,000 years of life if all U.S. patients with advanced non–small cell lung cancer (NSCLC) for whom the therapy is indicated received the treatment.
Furthermore, the analysis found that 1 in 4 newly diagnosed patients and 1 in 10 patients with previously treated lung cancer are expected to live beyond 5 years after treatment initiation, which is substantially longer than if they were treated with standard therapies, although the full impact of immunotherapy on longer-term survival is not yet known. The CENTRA estimates are based on an analysis of clinical trial results and cancer incidence and population data, taking into account differences by race and gender in NSCLC incidence and life expectancy.
Impact of Improved Therapies on Survival
Since 2015, the FDA has approved three checkpoint inhibitors in the treatment of lung cancer: nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). A fourth such agent, durvalumab (Imfinzi), a programmed cell death ligand 1 (PD-L1) inhibitor recently granted approval by the FDA for the treatment of locally advanced NSCLC after the administration of chemotherapy plus chest radiotherapy. And in 2017, pembrolizumab became the first cancer treatment to receive a tumor-agnostic indication from the FDA, allowing use of the drug to treat any type of solid tumor that has mismatch-repair deficiency. In total, from November 2016 to October 2017, the FDA approved 31 new therapies for more than 16 types of cancer.
With decades of advances in cancer treatment, more Americans are living as cancer survivors—15.5 million (nearly 1 in 20), up from 11.4 million in 2006.2 By 2040, that number is expected to grow to 26 million, with 73% of those survivors aged 65 and older.3
Ensuring All Patients Benefit From Advances
In conjunction with the release of its Clinical Cancer Advances 2018 report, ASCO held a press briefing at the National Press Club in Washington, DC, on the State of Cancer Care in America, followed by a discussion about how precision oncology is expanding treatment opportunities for patients and saving lives. During the briefing, Clifford A. Hudis, MD, FACP, FASCO, Chief Executive Officer of ASCO, credited federal investment in cancer research with the progress being made in more effective therapies for patients. He urged increased funding to accelerate future cancer breakthroughs, which the majority of Americans—91%—also support.4
“The National Cancer Institute (NCI) funded the very first clinical trial of CAR T-cell therapy in children with acute lymphoblastic leukemia, and the NCI was among the first to report the possible role of CAR T-cell therapy in multiple myeloma,” said Dr. Hudis. “So this is the never-ending plea for all of us to work collectively, advocating for continued increases in support at the federal level.” Dr. Hudis also acknowledged the importance of ensuring that all patients with cancer benefit from precision oncology advances.
“The question, of course, becomes what does the future hold? How do we make sure that the right therapy—the best therapy—is available to every single patient who will benefit? And here I want to call out a specific perspective that we bring from ASCO. It is our view that precision medicine shouldn’t only be about this exciting cutting-edge science and the cancer treatments being delivered to a select few,” said Dr. Hudis.
“It should also be about making sure that the highest-quality care is available to all eligible members of society on the basis of science and that this should all be deployed in a way that reflects the individual patient’s goals and aims,” he continued. “It [should involve] personalization of the care decisions, so that everybody’s needs and wants are appropriately matched, and we think this is one of several critical next steps for precision medicine.”
Hope vs Hype of Precision Medicine
ASCO President Bruce E. Johnson, MD, FASCO, Chief Clinical Research Officer and Institute Physician at the Dana-Farber Cancer Institute, Boston, also stressed the need to expand access to new cancer therapies.
“I still treat people with lung cancer, so I’ve been able to witness the revolution first-hand and see how precision medicine is being introduced into the management of our patients,” said Dr. Johnson. “Precision medicine is currently allowing us to deliver better cancer care faster than we have before, in defined subsets of patients. “We hope the promise of precision medicine is that more people can benefit from it, not only at the academic centers, but also where most patients are treated—in the community cancer centers.”
Cost vs Value
Underlining the promise of precision therapies, especially CAR T-cell immunotherapy, is their considerable cost—$475,000 for tisagenlecleucel and $373,000 for axicabtagene ciloleucel—vs their value. A panel discussion at the briefing, moderated by Richard L. Schilsky, MD, FACP, FASCO, ASCO’s Senior Vice President and Chief Medical Officer, explored the challenges to realizing the full potential of precision medicine in cancer care. Dr. Schilsky asked panel member Robert W. Dubois, MD, PhD, Chief Science Officer and Executive Vice President of the National Pharmaceutical Council, to explain “how the precision medicine approach potentially creates value even in the face of what are acknowledged to be very expensive treatments.”
“Personalized medicine is absolutely moving us to a crisper, definable value proposition. We have increasingly personalized medicine, but we have a completely impersonalized payment system. We want to put fewer barriers in front of the patient who has an opportunity for curative or effective high-value therapy,” Dr. Dubois explained.
“For disorders like hypertension and diabetes, for example, there are health plans that make drugs low cost or maybe even free of charge because they want patients to take them. But that concept of a value-based insurance design hasn’t really hit the oncology world. And that’s what we need to see,” he continued.
“The last thing we want to see is when a patient pays a lot of money for a therapy that doesn’t work, and the next patient says I can’t afford it and walks away from CAR T-cell therapy. If we don’t solve that [problem], we will not have won the battle,” said Dr. Dubois.
Future of Oncology Care
While acknowledging that not all patients with cancer are reaping the rewards from advances in personalized medicine—in 2016, nearly 600,000 Americans died from their disease5—Dr. Schilsky called the progress made over the past 3 decades in oncology care “breathtaking.”
“I used to be a therapeutic nihilist as it relates to immunotherapy,” said Dr. Schilsky. “Many of us in my generation grew up believing it would never work. But I think all of us probably can now foresee a time in the next 10 to 15 years when immunotherapy will be the initial treatment of choice for the majority of patients with cancer. And many of those patients will actually be cured.”
He added: “It’s a remarkable time in cancer research and cancer care…. I tell every young doctor I run into to get into oncology because it’s going to be the most exciting part of medicine right now.” ■
DISCLOSURE: Drs. Hudis, Johnson, Schilsky, and Dubois reported no conflicts of interest.
REFERENCES
1. Heymach J, Krilov L, Alberg A, et al: Clinical Cancer Advances 2018: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology. J Clin Oncol. January 30, 2018 (early release online).
2. American Cancer Society: Cancer Facts & Figures 2017. Available at www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html. Accessed March 6, 2018.
3. Bluethmann SM, Mariotto AB, Rowland JH: Anticipating the ‘silver tsunami’: Prevalence trajectories and comorbidity burden among older cancer survivors in the United States. Cancer Epidemiol Biomarkers Prev 25:1029-1036, 2016.
4. Harris Insights & Analytics: National Cancer Opinion Survey. Prepared for ASCO, October 2017. Available at www.asco.org/sites/new-www.asco.org/files/content-files/research-and-progress/documents/ASCO-National-Cancer-Opinion-Survey-Results.pdf. Accessed March 6, 2018.
5. National Cancer Institute: Cancer statistics. Available at www.cancer.gov/about-cancer/understanding/statistics. Accessed February 12, 2018.
MORE ON IMMUNOTHERAPY
For further discussion of CAR T-cell therapy and other immunotherapies in cancer treatment, see interviews with experts recorded at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium on The ASCO Post Newsreels at www.ascopost.com/videos.
