Pfizer reported positive topline PFS results for encorafenib plus cetuximab and FOLFIRI in BRAF V600E-mutant mCRC from BREAKWATER cohort 3. The regimen showed significant PFS improvement and clinically meaningful OS benefit, with no new safety signals.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
The global oncology market is projected to nearly triple from $279.98 billion in 2026 to $748.17 billion by 2035, driven by rapid adoption of immunotherapy, checkpoint inhibitors, and cell therapies across solid tumors and hematologic cancers.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
New combination therapies demonstrate improved outcomes in advanced anal and colorectal cancers, with retifanlimab plus chemotherapy approved for anal cancer and onvansertib showing strong efficacy signals in RAS-mutated colorectal cancer.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Pfizer announced positive results from Cohort 3 of the Phase 3 BREAKWATER trial, showing BRAFTOVI combined with cetuximab and FOLFIRI significantly improved progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
Oncolytics Biotech announced FDA Fast Track Designation for pelareorep combined with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal cancer, driving shares up 19.7%.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07702032 |
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1) |
RECRUITING | PHASE3 |
| NCT07649655 |
EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07446322 |
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07323576 |
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer |
WITHDRAWN | PHASE2 |
| NCT07318389 |
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07221357 |
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer |
RECRUITING | PHASE2/PHASE3 |
| NCT07021950 |
AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06867822 |
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer |
RECRUITING | PHASE1 |
| NCT06747845 |
Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy |
RECRUITING | PHASE2 |
| NCT06663319 |
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers |
RECRUITING | PHASE1 |
