The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
The trial will assess Precem-TcT, both as monotherapy and in combination with bevacizumab, in patients whose disease has progressed after or become resistant to standard treatments
Under the collaboration, Symeres will test Ambagon’s newly designed molecular glues using in vitro assays and mechanistic studies
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC)
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
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
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
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