Pfizer’s colon cancer Combo Therapy shows positive results in Phase III BREAKWATER trial

USA—American pharmaceutical giant Pfizer has announced that its combination therapy for metastatic colorectal cancer (mCRC) has achieved significant milestones in the Phase III BREAKWATER trial.

This therapy combines Braftovi (encorafenib), Erbitux (cetuximab), and the chemotherapy regimen mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin).

The trial focused on patients with mCRC who have a BRAF V600E mutation and had not received prior treatment.

The BREAKWATER trial met one of its primary goals by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

This means that patients receiving the combination therapy experienced a longer period without disease progression compared to those on standard treatments.

Additionally, the study reported a notable improvement in overall survival (OS), indicating that patients lived longer overall when treated with this regimen.

The U.S. Food and Drug Administration (FDA) granted accelerated approval for this combination therapy in December 2024.

Following the positive results from the BREAKWATER trial, Pfizer plans to present these findings to the FDA to seek full approval.

 Importantly, no new safety concerns were identified during the trial, suggesting that the therapy’s safety profile is consistent with previous studies.

Dr. Roger Dansey, Pfizer’s Chief Oncology Officer, expressed optimism about the trial’s outcomes, highlighting that the results could be transformative for patients with this specific cancer mutation, who have historically faced limited treatment options and poor prognoses.

Dr Dansey emphasized that the Braftovi regimen is emerging as a new standard of care, being the first targeted therapy approved for first-line use in patients with mCRC harbouring a BRAF V600E mutation.

The BREAKWATER trial is notable for being the first initiated under the FDA’s Project FrontRunner.

This initiative encourages the development of treatments for patients at earlier stages of their disease, rather than focusing solely on those who have exhausted multiple therapies.

In the trial, patients were randomly assigned to receive either the combination of Braftovi and Erbitux, with or without mFOLFOX6, or standard chemotherapy regimens.

 The control group received treatments such as mFOLFOX6, FOLFOXIRI (a combination of folinic acid, fluorouracil, oxaliplatin, and irinotecan), or CAPOX (capecitabine and oxaliplatin), with or without bevacizumab.

The BRAF V600E mutation leads to uncontrolled cell division, contributing to cancer progression. This mutation is present in approximately 8-12% of mCRC cases and is associated with poorer outcomes.

 While some BRAF mutations respond to targeted therapies, others do not, underscoring the importance of personalized treatment approaches.

In related developments, Tizona Therapeutics is expanding its Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with mCRC.

Additionally, Johnson & Johnson reported a 49% overall response rate in a colorectal cancer study involving their drug RYBREVANT.

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