At this ASCO, how does Merck view the PD-1/VEGF assets?

At this year's ASCO, two transactions involving PD-1/VEGF bispecific antibodies, as well as the data readout of CanSino/Summit's PD-1/VEGF Ivoris monoclonal antibody, became the focus of the entire pharmaceutical market.

As the owner of the drug Keytruda, Merck (MSD) also detailed its strategies for tumor immunotherapy and ADC therapies, which are worth investors' attention.

At this year's ASCO, Merck stated that it is actively adjusting its product pipeline and R&D strategy in the field of tumor treatment, focusing on PD-1/VEGF bispecific antibodies and antibody-drug conjugates (ADCs) to address the challenges posed by the impending expiration of its core product Keytruda's patent.

The company expects that by the mid-2030s, its late-stage tumor pipeline is expected to bring in over $25 billion in commercial opportunities, with ADCs expected to contribute more than half of that.

PD-1/VEGF, Rapid Exploration of Data in China, Advancing ADC Combination Therapy

Merck believes that the biological mechanism of combining PD-1 and VEGF has been validated, with improvements in progression-free survival (PFS) observed across various indications. However, management also pointed out that while the data shows clinically meaningful overall survival (OS), the statistical significance of OS benefits remains an "open question."

Merck has obtained global exclusive rights to the PD-1/VEGF bispecific antibody LM-299 (internal code MK-2010) through a collaboration with LaNova Medicines. This project is currently undergoing Phase I/II clinical research primarily in China. Merck stated that the choice to conduct early research in China is to leverage the country's clinical research infrastructure and collaborate with local partners to accelerate the exploration of combination therapy strategies, providing information for subsequent dose optimization and larger-scale global development in the U.S. Merck also mentioned the possibility of combining MK-2010 with novel ADCs, including Sac-TMT.

The competition in the PD-1/VEGF bispecific antibody field is fierce, with CanSino Biologics/Summit's Ivoris monoclonal antibody making progress in non-small cell lung cancer (NSCLC), and Pfizer also entering the field through a collaboration with 3SBio. The future key for MK-2010 lies in whether it can demonstrate clear clinical benefits based on mature OS data.

Accelerating the Advancement of the Industry's Broadest ADC Projects

Merck views ADCs as an important component of its future tumor pipeline and claims to be advancing "one of the industry's broadest ADC projects." The company expects ADCs to contribute more than half of the anticipated revenue from its late-stage tumor pipeline.

Among them, the TROP2 ADC Sacituzumab Tirumotecan (sac-TMT, also known as SKB264 or MK-2870), developed in collaboration with Keren Biotechnology, is one of the core projects Keren Biotechnology's early clinical research in China has demonstrated the potential of the drug, particularly in patients with treated EGFR mutation NSCLC and triple-negative breast cancer (TNBC). Sac-TMT has been approved in China for the treatment of TNBC and locally advanced or metastatic EGFR mutation NSCLC (the first TROP2 ADC approved for lung cancer in China) and has received breakthrough therapy designation from the FDA in the United States for specific treated advanced or metastatic non-squamous NSCLC patients with EGFR mutations.

Merck executives described Sac-TMT as a "just right" "workhorse ADC" during the ASCO 2025 investor event.

Its differentiated strategy is mainly reflected in the dosing regimen (once every two weeks), toxicity profile (manageable safety), and development plans, such as exploring its application in maintenance therapy and avoiding the dosing adjustment challenges that may arise from direct combination with platinum-based chemotherapy. Merck has planned 14 registrational studies for Sac-TMT, several of which have the potential to become "first-in-class."

Competitors in the TROP2 ADC field include Gilead's Trodelvy and AstraZeneca/Daiichi Sankyo's Datopotamab deruxtecan (Dato-DXd).

Future Oncology Treatment Plans and BD&MA

Merck's oncology development draws on the experience of Keytruda, with its pipeline mainly divided into three categories:

1. Immuno-oncology drugs aimed at stimulating immune responses (such as the subcutaneous formulation of K drug and other immune agonists);

2. Precision targeted drugs aimed at affecting cancer growth pathways (such as the KRAS G12C inhibitor MK-1084);

3. ADCs aimed at targeting chemotherapy and immune cell activation. The company's goal is to address tumor types with poor PD-(L) 1 inhibition effects (such as small cell lung cancer, colorectal cancer, and hematological malignancies) and explore better treatment combinations. For example, the combination of K drug and KRAS G12C inhibitor MK-1084 has entered Phase III clinical trials.

In terms of BD&MA, Merck's standard is whether "the pathway, technology, or clinical design of the target demonstrates an unambiguous promotable advantage," and whether Merck can "significantly drive the market" with its own strength.

A noteworthy statement regarding BD&MA is that "demonstrating an unambiguous promotable advantage" is quite clear For example, if the OS data is significant + can sell better than the existing drugs in hand, does it mean that Merck still has the possibility to act when the PD-1/VEGF OS data is significant?

In addition to the collaboration with Lixte Biotechnology and Kelun-Biotech, Merck also previously acquired Tongrun Biopharmaceutical, which owns the next-generation CD3/CD19 bispecific antibody CN201.

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