For Stakeholders in Immuno-Oncology, Is the Third Time the Charm?

FOR IMMEDIATE RELEASEFebruary 25, 2015For Stakeholders in Immuno-Oncology, Is the Third Time the Charm?

PLAINSBORO, N.J.—For those who treat cancer patients and for payers who fund their care, deciding whether a treatment has value has always involved what Bruce Feinberg, DO, calls “the triad” of efficacy, toxicity, and cost. But today, as the third wave of immuno-oncology moves beyond the research phase and into clinical practice, balancing those 3 factors has never been more challenging.

Dr Feinberg, vice president and chief medical officer for Cardinal Health Specialty Solutions, draws on his 30 years of waiting on the promise of immuno-oncology in his commentary, “Impacting Stakeholder Adoption of Immuno-Oncology,” which appears in a special issue of Evidence-Based Oncology (EBO) devoted to the topic. EBO is an indexed publication of The American Journal of Managed Care. To access the commentary, click here.

In the piece, Dr Feinberg recalls the enthusiasm in the mid-1980s, when he was a fellow at MD Anderson Cancer Center in Texas, and the concept of harnessing the body’s own immune system to fight cancer was just emerging. Dr Feinberg himself had significant research on the topic published in the Journal of the American Medical Association and also presented his work at the annual meeting of the American Society of Clinical Oncology.

But as he recounts, there was much to learn. Dr Feinberg writes, “The enthusiasm over this first generation of immuno-oncology agents was eventually tempered by toxicity and limited efficacy, leading to the commercialization of only a handful of agents that would have an impact on relatively small disease populations.” A second wave of research into immunotherapy vaccines, led by Steven A. Rosenberg, MD, PhD, at the National Cancer Institute, yielded insights into how tumors circumvent immunoregulatory mechanisms, but widespread commercial success remained elusive.

Immuno-oncology, however, has turned a corner. Approvals of ipilimumab to treat metastatic melanoma and sipuleucel-T to treat minimally symptomatic metastatic prostate cancer offer only a glimpse of what could come with this “third wave.”

Recent FDA approvals of nivolumab and pembrolizumab capitalize on the area of greatest promise: targeting the PD-1, or “programmed cell death” pathway. Blocking this protein can potentially be used to treat a variety of tumor types, under different conditions, and trials abound to learn which patients can benefit. What’s more, in addition to significant tumor shrinkage, the PD-1 inhibitors appear to create a “memory immune response” in T-cells, at least for some patients. As data on patients who have been treated matures, it appears that for some, the effects of therapy can last years.

He contrasted this with targeted therapies, which may produce powerful but not long-lasting results, writing, “What makes immuno-oncology seem so transformative and, thereby, so appealing is the gestalt of panacea, therapies that are histology agnostic unleashing an immune system to recognize self from abnormal self, regardless of cell origin.”

Crossing this frontier is not without a price. Dr Feinberg outlines how achieving stakeholder buy-in for therapies that will be incredibly expensive—and still not curative—will require collaboration among everyone in oncology, including the drug developers. He notes that the last 10 oncology drugs to reach the US market, including ipilimumab, sipuleucel-T, nivolumab and pembrolizumab, cost more than $10,000 a month.

“Although the cost versus value can be debated, cost has increasingly become a factor in stakeholder adoption,” Dr Feinberg writes.

With the “third wave” of immuno-oncology upon us, however, the question of what makes a cancer therapy worth the price cannot be avoided. “Rapid responses, durable tumor control, and long-term survival through harnessing the power of the immune system are now realities,” Dr Feinberg writes.

About the Journals

The American Journal of Managed Care (AJMC) celebrates its 20th year in 2015 as the leading peer-reviewed journal dedicated to issues in managed care. Other titles in the franchise include The American Journal of Pharmacy Benefits, which provides pharmacy and formulary decision-makers with information to improve the efficiency and health outcomes in managing pharmaceutical care, and The American Journal of Accountable Care, which publishes research and commentary on innovative healthcare delivery models facilitated by the 2010 Affordable Care Act. AJMC’s Evidence-Based series brings together stakeholder views from payers, providers, policymakers and pharmaceutical leaders in oncology and diabetes management. To order reprints of articles appearing in AJMC publications, please call (609) 716-7777, x 131.

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