Pfizer’s metastatic colorectal cancer (mCRC) combination therapy has met one of the primary endpoints of improving progression-free survival (PFS) in a Phase III trial, further supporting a full approval.
The company’s active-controlled, open-label BREAKWATER trial (NCT05217446) evaluating a combination of Pfizer’s Braftovi (encorafenib), Eli Lilly’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) met one of its dual primary endpoints, improving PFS.
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The trial investigated the combination in mCRC patients living with a BRAF V600E mutation who are treatment-naive.
The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Additionally, the company has added that no new safety signals have been observed.
In December 2024, the US Food and Drug Administration (FDA) granted accelerated approval to the combination therapy of Braftovi, Erbitux and mFOLFOX6. Although it is waiting on full analysis of the final results, Pfizer intends to present its findings in a meeting with the FDA to support full approval.
Speaking ahead of World Cancer Day on 4 February, Pfizer’s chief oncology officer Roger Dansey said: “We are extremely pleased with the clinically meaningful PFS and OS results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes.
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By GlobalData“The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation.”
The multi-centre BREAKWATER trial is also the first trial to be launched under the regulatory body’s Project FrontRunner, an initiative aimed at encouraging sponsors to seek approval for drugs for patients in an earlier stage of clinical treatment. This is as opposed to seeking approval for treatments designed for patients who have already undergone several therapies or treatment options.
In the BREAKWATER trial patients were randomised to receive either 300mg of Braftovi and Erbitux alone or in combination with mFOLFOX6. The active control group received mFOLFOX6, FOLFOXIRI (Folinic acid, fluorouracil, oxaliplatin and irinotecan), or CAPOX (capecitabine and oxaliplatin) with or without bevacizumab.
A BRAF mutation is a form of cancer in which the BRAF gene begins to cause certain cells to continue dividing without ever receiving a signal to stop. The V600E variant is one of the more common forms of BRAF mutation with the name defining the location and nature of the condition. While some BRAF mutations are susceptible to different forms of targeted therapy, other BRAF mutations are not.
Elsewhere in the treatment of mCRC, Tizona Therapeutics has expanded its ongoing Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with the condition. Meanwhile, Johnson & Johnson has reported a 49% overall response rate in a colorectal cancer study with RYBREVANT.
