Pfizer PFE announced positive top-line results from the progression-free survival (PFS) analysis of a late-stage study of its oncology drug, Braftovi (encorafenib), for treating patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. Braftovi is an oral small-molecule kinase inhibitor that targets BRAF V600E.

The phase III BREAKWATER study is evaluating the candidate's safety and efficacy in combination with Eli Lilly’s LLY Erbitux (cetuximab) and chemotherapy (mFOLFOX6) in mCRC patients harboring a BRAF V600E mutation.

Per the data readout, a statistically significant and clinically meaningful improvement in PFS, one of the dual primary endpoints of the study, was observed upon treatment with the Braftovi combination regimen compared with chemotherapy with or without Roche’s Avastin (bevacizumab). Additionally, Pfizer’s Braftovi combination showed a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint.

In the past three months, PFE shares have lost 5.5% compared with the industry’s 6.4% decline.

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Please note that in December 2024, Pfizer received accelerated approval from the FDA for its Braftovi combo regimen to treat treatment-naïve patients with BRAFV600E-mutant mCRC. The approval was based on a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR), the study’s other dual primary endpoint. 

At the time of the ORR analysis, the safety profile of Braftovi in combination with Lilly’s Erbitux and mFOLFOX6 remained consistent with the established safety profiles of each agent. Treatment-related adverse events were mostly mild to moderate in severity. No new safety concerns were observed.

Pfizer plans to share detailed results from the PFS analysis of the phase III BREAKWATER study to support the conversion of the accelerated approval to full approval.

Braftovi was a combination with Lilly’s Erbitux for adults with mCRC with a BRAF V600E mutation after prior therapy. The BREAKWATER study data is being reviewed by global regulatory authorities for potential further approvals in other geographies. Besides the CRC indication, Braftovi is also approved for several other types of cancer.

CRC Offers a Lucrative Market in the United States

CRC is one of the most common types of cancer globally. In the United States, an estimated 154,270 new cases and 53,000 deaths are expected in 2025. Around 20% of CRC cases are metastatic at diagnosis, and up to 50% of localized cases eventually spread.

BRAF mutations are found in 8-12% of mCRC cases and are linked to a poorer prognosis. The BRAF V600E mutation is the most common and more than doubles the risk of death compared to patients without any mutation. Despite the high unmet need, no biomarker-driven therapies were approved for previously untreated BRAF V600E-mutant mCRC until December 2024. Thus, Pfizer has the first-mover advantage in the market for BRAF V600E-mutant mCRC treatments and has the potential to capture a large market share.

Pfizer Inc. Price and Consensus

Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote

PFE's Zacks Rank & Stocks to Consider

Pfizer currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL and Alnylam Pharmaceuticals ALNY, each sportinga Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $1.70. In the past three months, shares of Castle Biosciences have lost 7.6%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The consensus estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 3.5%.

ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

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