Antonio Passaro: Why is this press release of Bristol Myers Squibb so crucial for our community?
Antonio Passaro, Medical Director at the Institute of European Oncology (IEO), shared a post on X/Twitter:
“Why is this press release of Bristol Myers Squibb so crucial for our community? During ESMO20, the results of CodeBreak-200 were presented, later published in The Lancet, showing a Progression-Free Survival (PFS) improvement with sotorasib vs. docetaxel by just over a month: 5.6 vs. 4.5 months, with an HR of 0.66.
While these results are positive, they have left stakeholders perplexed, given the urgent therapeutic need for targeted anti-KRAS agents in clinical practice.
Based on these results, the FDA Oncology Oncologic Drug Advisory Committee (ODAC) voted that the PFS of sotorasib cannot be reliably interpreted vs. docetaxel in this trial. Instead of voting on whether CodeBreak-200 should be used to convert accelerated approval to traditional approval for sotorasib, the committee voted on whether the primary endpoint of PFS per Blinded Independent Central Review (BICR) could be reliably interpreted in CodeBreak-200.
The committee ultimately decided that the PFS could not be reliably interpreted. Worldwide different countries lack access to direct KRAS p.G12C agents like Sotorasib. The KRYSTAL-12 study results offer a potential opportunity for clinicians and patients. Today, starting indirect comparisons vs Sotorasib is not useful.”
Source: Antonio Passaro/X
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