Pfizer’s Potential Novel Cancer Therapy: Insights from Our Latest Pfizer Pflash

December 4, 2025

Oncology is a key area of focus for Pfizer, and we are dedicated to advancing innovation to address unmet medical needs for patients living with cancer. As diseases like lung cancer and colorectal cancer continue to pose a significant global health burden, the need for transformative innovation in cancer care remains urgent.

In July of this year, we closed an exclusive licensing agreement with 3SBio, providing Pfizer with global, ex-China rights to a novel bispecific antibody, PF’4404 (“‘4404”), which we believe has the potential to become a next-generation backbone therapy across multiple cancer types.

In the latest Pfizer Pflash, Francesca DeMartino, Pfizer’s Chief Investor Relations Officer sat down with Jeff Legos, Chief Oncology Officer, for a deep dive into ‘4404 – including its differentiated features, its strategic fit within our Oncology portfolio, and our ambitious clinical development plans underway.

Transforming Pfizer’s Oncology Portfolio: Meet PF’4404

What distinguishes ‘4404 is its ability to simultaneously target and block two key cancer pathways:

PD-1: A key receptor that typically acts to prevent immune cells from attacking cancerous cells.
VEGF: A protein that plays an important role in tumor blood vessel formation.

The combination of these two established mechanisms – PD-1 and VEGF inhibition – in a single molecule, like ‘4404, has the potential to achieve superior efficacy versus PD-1 inhibition alone. If the initial data achieved with the PD-1xVEGF combination can be proven in global studies and in additional treatment settings and tumor types, the results could be truly transformational for patients with cancer.

We believe ‘4404 is a foundational asset and a seamless bet in Pfizer’s Oncology strategy for several reasons:

Builds on our established presence: Many of the areas where this bispecific may have significant impact align with our established disease areas of focus – including cancers like lung, bladder and colorectal, where there is significant unmet need.
Enabled by our deep technical expertise: ‘4404 is a multi-specific antibody, one of our three core modalities where we have deep experience and industry-leading capabilities.
Potential to unlock synergies: There's an opportunity to explore combinations with our industry-leading antibody-drug conjugates (ADC) portfolio.

Three-Pronged Strategy for Clinical Development and Value Creation

Understanding the transformational potential of ‘4404, Pfizer is committed to developing this potential medicine with speed, breadth and depth. Our industry-leading capabilities uniquely position us to create value with ‘4404 through our three-pronged strategy:

Speed: In the near term, we are expecting seven new clinical trial starts, including two pivotal Phase 3 studies, in the first of many planned waves.
Breadth: We are exploring multiple key disease areas where ‘4404 may have significant impact, underpinning our broad goal of developing the therapy across tumor types.
Depth: Pfizer’s unique blend of capabilities, focus and modalities positions us to develop ‘4404 across multiple treatment settings, lines of therapy, and in novel combinations within a given disease area.

Substantial Opportunities in Lung Cancer and Colorectal Cancer

The tumor types encompassed by the ‘4404 development plan represent attractive opportunities in disease areas with a large unmet medical need. In our first wave of trial starts, we are focused on improving outcomes for patients with lung cancer and colorectal cancer, areas in which current standard-of-care treatments provide only modest improvements in survival.

In lung cancer, we are excited to add to our robust portfolio of approved therapies, including Lorbena and the Braftovi + Mektovi combination, as well as late-stage lung cancer agents currently in development. Initial studies for ‘4404 are focused on later stage forms of the disease, but we also see the potential for the therapy in earlier settings of non-small cell lung cancer treatment.

On colorectal cancer, which is the second most frequent cause of cancer-related death in the United States¹, we are also advancing efforts to improve outcomes for patients. Already, ‘4404 has shown positive results in trials conducted by 3SBio for patients with metastatic colorectal cancer. We are planning a Phase 3 study evaluating ‘4404 that we believe could support a potential approval in first-line metastatic colorectal cancer, as well as our broader ambition of redefining the current treatment paradigm.

Not only will ‘4404 help reach significant unmet needs, but it also importantly aligns with Pfizer’s current commercial presence. Lung cancer and colorectal cancers represent large and growing markets, expected to reach approximately $70 billion² and $9 billion³ by 2030, respectively.

Overall, we view PF’4404 as a seamless fit with Pfizer's Oncology strategy, and we are excited about the potential of establishing it as a backbone therapy across multiple tumor types.

For more information on PF’4404 and our ambitious development plan to create value with this potential foundational asset, we invite you to watch the full Pfizer Pflash.

^{1 Siegel et al. Cancer J Clin, 2025;75(1):10-45.

2} Evaluate Ltd market size estimates (includes NSCLC and SCLC). Numbers are rounded.
³Evaluate Ltd market size estimate. Numbers are rounded.

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