October 2015 Edition Vol.11, Issue 10

ACCC-ICLIO: Navigating the Future of Immuno-Oncology and Who’s Going to Pay for It

ACCC-ICLIO: Navigating the Future of Immuno-Oncology and Who’s Going to Pay for It

By Chase Doyle

 

With immunotherapies already being used to treat more than a dozen different tumor types and hundreds of clinical trials ongoing, it’s safe to say that the era of immuno-oncology (I-O) has arrived.

For a few disease states, the results have been remarkable—pushing survival in previously hopeless patient populations to startling lengths and providing hope for many more.

And yet, immunotherapy is no panacea.  Nor is it cheap.

As agents continue to pervade the market, education will be critical, not just for clinicians, but for financial advocates, nursing and pharmacy teams, and patients, too, who are often forced to confront both physical and financial toxicities.

In other words, it’s essential for cancer care providers to go beyond a clinical understanding of I-O to tackle real-world issues.

“When we saw this breakthrough technology coming, we wanted to get ahead of it,” said Christian Downs, JD, MHA, Executive Director of the Association of Community Cancer Centers (ACCC), “not only so that we could make it available to our patients and the providers in the community, but so that those of us in the community setting could be on the forefront of treatment.”

With this goal in mind, the first national meeting of the Institute for Clinical Immuno-Oncology (ICLIO), an ACCC initiative, was held October 2, 2015 in Philadelphia. Offering five areas of focus—clinical optimization, coverage & reimbursement, management best practices, training & development, and patient access—the ICLIO program looks to provide a comprehensive roadmap for I-O implementation.  Established by ACCC, the Institute for Clinical Immuno-Oncology (ICLIO) is the premier source of immuno-oncology resources for members of the multidisciplinary cancer care team who seek to provide their patients with cutting-edge treatment. Comprehensive resources are available at accc-iclio.org.

“We must have a team-based approach to the management of patients with this new therapy,” said Mr. Downs, “so that community providers can deliver benefit to patients in need—effectively and efficiently.”

Growing List of Agents
 

As it secures its place alongside surgery, chemotherapy, and radiation as the fourth pillar of cancer treatment, immunotherapy has expanded its reach beyond the world of metastatic melanoma, but its effect on that disease remains a marvel.

“We have a fairly sizeable patient population that is, indeed, achieving complete remissions and – I dare say – are cured of their stage IV malignancy,” said Sigrun Hallmeyer, MD, Oncology Specialists S.C., Park Ridge, IL. “As little as five years ago, before the approval of ipilimumab, these patients would have died in six months.”

Now, I-O agents are being developed as both monotherapy and combination therapies to treat a number of tumor types, including: bladder, breast, colorectal, esophageal, gastric, head and neck, hepatocellular, leukemia, lung, lymphoma, melanoma, ovarian, pancreatic, prostate, and renal cell carcinoma.

The problem is: not all patients are responsive.

Searching for Biomarkers
 

Despite the impressive results, Lee S. Schwartzberg, MD, Chair of the ICLIO Advisory Committee and Chief of Hematology & Oncology at the University of Tennessee Health Science Center, reminded the audience that it’s still a minority, in most cases, that are benefiting from the current wave of immuno-therapeutic agents.

“Immunotherapy seems to work broadly in subsets of patients,” said Dr. Schwartzberg, “so we have to understand what those subsets are. In certain subsets, it may be patients who have a big mutational load, as we see in GI cancers. We’re just at the very beginning of understanding who the patients are that are going to benefit.”

Although the recent FDA-approval of pembrolizumab for metastatic non-small cell lung cancer (NSCLC) requires a companion test to assess the expression of PD-L1 (the protein’s ligand), Dr. Schwartzberg noted that this test was lacking the sophistication of a true biomarker. The problem is that while high PD-L1 expression is related to response (at least in some tumor types), some patients who lack PD-L1 expression can also respond. Selection for patients for this expensive drug, therefore, is not straightforward.

“The complexity of the interaction between the tumor and the immune system and the tumor and the stroma is fantastic,” he said. “We’re just beginning to scratch the surface of what’s really important.”

Particularly for drugs that are given long-term and are expensive, discovery of a reliable biomarker, he said, could help save patients from the untold costs and suffering of futile therapies.

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