Timothée Olivier: Wow, a long awaited decision about the CodeBreaK 200 trial… with a PFS per BICR considered… unreliable!

Timothée Olivier, Clinic Director at HUG – Geneva University Hospitals, shared the following post by FDA Oncology, adding the following:

“Wow, a long awaited decision about the CodeBreaK 200 trial… with a PFS per BICR considered… unreliable!

We pointed many limitations, including this, right after the 2022 ESMO presentation more than 1 year ago…”

Quoting FDA Oncology’s post:

“FDA Oncologic Drugs Advisory Committee voted 10-2 against the question: Can the primary endpoint, PFS per blinded independent central review, be reliably interpreted in CodeBreaK200? Re: sotorasib for KRAS G12C mutated advanced/metastatic NSCLC.”

Source: Timothée Olivier/Twitter and FDA Oncology/Twitter