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Re: Transformative ...In addition to the change in the Illuminate-206 Phase ll trial outcome measures with regards to Overall Response Rate to Objective Response Rate in the primary outcome measures (October 2020), this also was included: Duration of response Durability or response per RECIST v1.1 [Time Frame: DOR will be evaluated every 8 weeks starting Cycle3 Day1 (each cycle is 28 days) for year 1 then every 12 weeks after the first year through study completion until all study participants have either progressive disease or start new anticancer treatment. ] Came across the following information from The World Journal of Clinical Oncology that was published last February which might be a reason for the change in wording and the additional Primary outcome measure of duration of response: Moreover, very recently, immunotherapy by checkpoint inhibitors has led to the development of more specific response criteria because the patterns of response and progression to immunotherapy are different than those of cytotoxic chemotherapy and targeted biologic agents[10]. Core tips: The tumor objective response rate is an important parameter in oncology. World Health Organization and Response Evaluation Criteria in Solid Tumors (RECIST) are anatomic response criteria developed mainly for cytotoxic chemotherapy. These criteria may not be optimal for biologic agents, some disease sites, and some regional therapies. Some alternatives of RECIST were developed, but RECIST v1.1 is validated in prospective studies, is widely accepted by regulatory agencies and has recently shown good performance for targeted cancer agents. The newest alternatives of RECIST are immune-specific response criteria for checkpoint inhibitors. Metabolic response assessments using positron emission tomography (PET) or PET/computed tomography may reflect the viability of cancer cells or functional changes that occur after anticancer treatments. Appreciate your medical perspective regarding all things related to Idera! |
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