SOURCE: Xtalks

Xtalks Webinars

August 25, 2016 07:00 ET

Upcoming Webinar to Examine Tumor Burden and Clinical Benefit Assessment in Immunotherapy Clinical Trials

TORONTO, ON--(Marketwired - August 25, 2016) - On Monday, September 19, 2016, Xtalks will host a complimentary webinar featuring Dr. Klaus Noever, Senior Director of Medical Affairs at WorldCare Clinical, LLC and Dr. Ryan Sullivan, Assistant in Medicine at the MGH Cancer Center, Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School, as the keynote speakers.

In a clinical trial, the treating investigator is responsible for deciding whether a trial participant continues on study. An important determinant on treatment decisions in solid metastatic tumors is the time course of lesion evolution as assessed by imaging using criteria such as the Response Evaluation Criteria in Solid Tumors (RECIST). According to RECIST, progressive disease (PD) is defined as a substantial increase in measurable or non-measurable disease or in the appearance of unequivocal new disease. Progressive disease suggests that a treatment is ineffective and therefore should be discontinued. RECIST has become the standard tumor assessment criterion for cytotoxic drugs and is accepted by regulatory agencies for evaluation of best overall response and time to progression as efficacy endpoints.

Immunotherapies may have a delayed efficacy profile resulting in initial PD followed by response, called pseudo-progression. Current imaging methods cannot distinguish between pseudo-progression and true progression. Most protocols suggest continuing immunotherapy beyond the first RECIST PD for patients without serious adverse events or clinical signs of progression. At the next imaging time point a modified set of radiographic response criteria, the so called immune related Response Criteria (irRC), are applied to check for confirmation of PD. Treatment will be discontinued in case of confirmed irRC PD or if the patient is "no longer clinically benefiting."

With immunotherapy, deciding on whether to continue treatment may become subjective and idiosyncratic. For large international trials where experience levels and treatment standards vary, a large degree of assessment heterogeneity can be introduced. In order to mitigate the concern, a central review committee can be established that takes into account clinical benefit, adverse events, and imaging results.

Numbers extracted from KEYNote-001 (Evaluation of Immune-Related Response Criteria and RECIST v1.1 in patients with advanced melanoma treated with pembrolizumab, Hodi et al. JCO 2016) illustrate the relevance of pseudo-progression. A RECIST PD occurred in 44% of patients. One third of the initial RECIST progressors were pseudo-progressors who mostly continued on treatment and had an improved overall survival compared to the remaining progressors.

This webinar will give an overview of endpoint assessment as it relates to RECIST, irRC, and clinical benefit in the setting of cancer immunotherapy. Recommendations on when and how to apply each criterion will be reviewed as will case histories illustrating the clinical decision-making needed to determine if a patient should continue treatment.

For more information or to register for this free webinar visit: Tumor Burden and Clinical Benefit Assessment in Immunotherapy Clinical Trials

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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