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The Challenges of Immuno-Oncology Clinical Development, Part III

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In the third 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. Though we have only begun to tap its potential, new immunotherapies have dramatically benefited thousands of patients across the United States, Europe and Asia in many indications, demonstrating more durable responses along with improved median overall survival and without significantly increased toxicity.

With the expectation that combination strategies hold more potential than monotherapy in many cases, sponsors are setting up combination trials as early as possible in clinical development. From the early phases through to approval, clinical development of I-O combination agents poses significant complexities that can be challenging to address.

Activating sites and enrolling patients in a competitive landscape

As additional I-O targets are identified and combined with existing and nascent therapies, the volume of clinical trials will continue to grow, generating increased demands for specific patient populations in an already crowded field. In many cases, we are seeing that established I-O sites, and even some relatively inexperienced sites, are inundated with competing studies. When entering this landscape, it can be difficult to find sufficient sites with I-O experience and access to treatment-naïve patents, especially sites experienced in adoptive T-cell therapies capable of running CAR T-cell, TCR, and TIL therapy studies.

New approaches are coming to market to accelerate identification of patients available for I-O trials. For example, Optimal Research, a U.S.-based site community, features a unique site activation model called Just in Time (JiT) that connects to patients within their own local communities. By expanding the pre-screening physician population to almost 1,000 oncologists in a myriad of indications, studies can expedite First Patient In (FPI), Last Patient In (LPI), or even boost lagging cohorts in early development studies.

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