Pfizer drug delivers breakthrough in late-stage blood cancer trial
Patients receiving ELREXFIO largely remained free from disease progression during the interim analysis
Patients receiving ELREXFIO largely remained free from disease progression during the interim analysis
Pharma giant targets new standards of care
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
The trial met its primary endpoint, with the combination therapy demonstrating a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival
The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI
The drug also showed a manageable safety profile, with just 6.4% of patients stopping treatment due to side effects. No new safety concerns emerged
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
The combination also outperformed chemotherapy on another important secondary endpoint
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