Martin Dietrich, Medical Oncologist at Cancer Care Centers of Brevard, shared a post on LinkedIn:
“Overcoming PD-1 resistance is a major unmet need in solid tumor oncology. RP1 has demonstrated ORR 33% in melanoma post PD-1 population, with similar efficacy in injected and non-injected lesions and substantial durability. Safety profile here was excellent. A concept of great interest for many indications.
After years of support for trial design, breakthrough designation and priority review designation, RP1 receives a CRL despite hitting all endpoints. Insisting on results of a randomized trial in a space where standard of care is NOT defined demonstrates a profound lack of clinical acumen. Offering arbitrary control arms for the sake of randomization hurt, not facilitate, scientific progress.
A major misjudgment by the FDA.”
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