Pfizer’s New Colorectal Cancer Trial Puts PF-08634404 Head-to-Head With a Market Standard

Pfizer Inc (PFE) announced an update on their ongoing clinical study.

Study Overview
This Phase 3 Pfizer study, officially titled “AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER,” aims to test whether Pfizer’s new drug PF-08634404 can improve outcomes for adults with metastatic colorectal cancer when added to standard chemotherapy. The trial compares the new medicine head-to-head with bevacizumab, a widely used standard treatment, making the results important for both clinical practice and the competitive landscape in colorectal cancer therapy.

Intervention/Treatment
The study tests PF-08634404, given by intravenous infusion, in combination with standard chemotherapy used for colorectal cancer. This is compared against bevacizumab, also given by IV, plus the same chemotherapy. PF-08634404 is designed to be a potential next-generation option that may improve survival or delay disease progression for patients whose cancer has spread.

Study Design
This is a randomized, double-blind, Phase 3 trial. Patients are randomly assigned, like a coin toss, to receive either PF-08634404 plus chemotherapy or bevacizumab plus chemotherapy. Neither patients nor doctors know which treatment each patient gets. The main goal is treatment benefit, measured by how long the cancer can be controlled and how safe the new drug is compared with the current standard of care.

Study Timeline
The study was first submitted on October 28, 2025, marking the start of formal trial setup and site activation. Participants are expected to remain in the study for about 33 months each, covering active treatment and follow-up. The primary completion and final completion dates are not listed here, but the timeline suggests readouts will likely cluster in the late 2020s, depending on enrollment and event rates. The latest update was submitted on January 9, 2026, confirming that the protocol and status are current and that recruitment is ongoing.

Market Implications
For investors, this trial pits Pfizer directly against bevacizumab-based regimens, which are key products in the oncology portfolios of competitors such as Roche. A positive outcome for PF-08634404 could unlock a sizable share of the metastatic colorectal cancer market, support Pfizer’s broader oncology growth narrative, and help diversify revenue beyond its COVID-era portfolio. Near term, the main impact is sentiment-driven: an active, late-stage, head-to-head trial signals commitment to oncology and can support valuation for Pfizer’s pipeline. However, with results still years away, any stock reaction is likely modest and tied to broader sector flows, trial enrollment progress, and updates at major oncology meetings. If the drug ultimately shows clear benefit or safety advantages over bevacizumab, it could pressure incumbents and shift standard treatment patterns across major markets.

The study remains active and recruiting, with up-to-date information available on the ClinicalTrials.gov portal under its current listing.

To learn more about PFE’s potential, visit the Pfizer Inc drug pipeline page.