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Activity Number:
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148
- Considerations in Clinical Trial Endpoints’ Selection
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Type:
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Invited
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Date/Time:
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Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #316721
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Title:
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Treatment-Free Survival and Depth of Response as Novel Endpoints of Immuno-Oncology (IO)-Based Therapy for Metastatic Renal Cell Carcinoma (MRCC)
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Author(s):
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Meredith M Regan* and Laura Fernandes
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Companies:
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Dana-Farber Cancer Institute and FDA
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Keywords:
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Endpoints;
Oncology
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Abstract:
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mRCC has seen the development and regulatory approval of several IO-based doublet regimens as initial therapy. A challenge in their clinical application and barrier in building on IO regimens is measurement of effect/success. Overall survival and RECIST-based endpoints of changes in tumor burden capture only some of their clinical effect. Using phase 3 trials of IO-based doublets, we aim to develop endpoints that capture clinically-relevant features of IO, including durable response off treatment; identify patients early in the course of therapy who will do well long-term; and provide early read-out of novel regimens to expedite drug development. We propose treatment-free survival, defined as the area between KM curves for two time-to-event endpoints defined from randomization (time to initial therapy cessation; and time to subsequent anticancer therapy initiation or death) to capture the potential period of durable disease control after IO-based doublet without subsequent therapy. We’re investigating whether a threshold of depth of response (DpR) of tumor burden reduction measurements early during initial therapy can define patients who achieve desirable long-term outcomes.
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Authors who are presenting talks have a * after their name.
