Cetuximab is an EGFR-targeted chimeric monoclonal antibody oncology therapy marketed as Erbitux. It is used in metastatic colorectal cancer and head and neck cancers, with biomarker selection in colorectal use. It is administered via intravenous infusion and is prescription-only.
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
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.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
AstraZeneca terminated its Phase I/IIa trial of AZD0022 for KRASG12D-mutant cancers, withdrew a planned saruparib ovarian cancer platform study, and completed a real-world non-small cell lung cancer treatment review.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07775287 |
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07746141 |
A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations |
NOT_YET_RECRUITING | PHASE1 |
| NCT07722754 |
Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial |
NOT_YET_RECRUITING | PHASE2 |
| 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 |
| NCT07678593 |
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07672483 |
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07659795 |
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07644559 |
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer |
RECRUITING | PHASE2 |
| NCT07618624 |
BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT07549399 |
SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC |
RECRUITING | PHASE3 |
