The Challenges of Immuno-Oncology Clinical Development, Part II

In the second of a four-part series, Jai Balkissoon, vice president of medical and scientific strategy, writes about the challenges in developing immuno-oncology therapies in combination clinical trials.

Immuno-oncology (I-O) has emerged as one of the most promising areas of cancer research. How do we integrate effective combination I-O therapies into our current clinical practice? There are an increasing number of therapies being combined with backbone CPIs in multiple tumor types. Emerging treatment options also include T-cell therapy combinations with backbone CPIs. One of the major challenges is the potential increased treatment related toxicities and financial toxicity seen with effective combination IO/IO therapies. The goal will be for patients to be able to receive effective and tolerable I-O treatments determined by specific biomarkers and to receive these treatments in their own community.

Planning for highly complex, specialized programs

Protocol and trial optimization, along with identification of the most experienced and capable sites, must address all specific challenges presented by the I-O clinical trial landscape. Successful strategy development of a clinical trial must analyze many facets including disease prevalence, the competitive environment, patient pathways, site experience and capabilities, shifting standards of care, regulatory landscape, biomarkers and specific protocol demands. Thus, a robust and comprehensive feasibility study is essential.

As more combination trials are started and planned around the globe, feasibility studies also can identify regions outside North America and Europe that have successfully operationalized

Designing innovative modernized trials

Clinical trials with combination I-O therapies have the potential for much-needed therapeutic benefits, but they also bring a higher risk of enhanced and unexpected toxicities. Considering that only 7 percent of all oncology agents that enter Phase I clinical trials are likely to gain U.S. Food and Drug Administration (FDA) approval, combination I-O trials with their additional questions about toxicity and sequencing require nimble decision-making to increase their odds of success.

Jai Balkissoon is a vice president of medical and scientific strategy. Read part one, part three and part four of this series. Read more in the white paper “Addressing key challenges in the clinical development of combination immuno-oncology therapies: A CRO’s perspective.”