Drug intelligence / Profile preview

ulevostinag + pembrolizumab

Development stage
Unknown
Lead developer
Merck
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intratumoral, Intravenous
01

Overview

**ulevostinag + pembrolizumab** is an investigational combination therapy of ulevostinag (MK-1454), a cyclic dinucleotide STING (stimulator of interferon genes) agonist, and pembrolizumab, a monoclonal antibody targeting the PD-1 (programmed cell death protein 1) immune checkpoint. Ulevostinag is administered via intratumoral injection and activates the STING pathway in the tumor microenvironment, promoting type I interferon production, immune cell activation, and antitumor immune responses. Pembrolizumab is administered intravenously and blocks PD-1 on T cells, releasing inhibitory signaling and enabling the immune system to attack tumor cells more effectively. The combination is being evaluated primarily in advanced and metastatic solid tumors—including head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC)—with a focus on anti-tumor activity, safety, and immune activation. Merck Sharp & Dohme LLC is developing both components, with clinical investigation on dosing, safety, and efficacy ongoing at Phase I–II stages. Preclinical and early clinical studies show STING pathway engagement, increased cytokine production, and evidence of synergistic antitumor activity, especially in HNSCC and TNBC patients refractory or naïve to anti–PD-1/PD-L1 therapy[1][3][5][7][9].

Other names
ulevostinag + pembrolizumabMK-1454 + pembrolizumabMK-1454 + MK-3475
02

Targets

STING (Stimulator of interferon genes protein)PDCD1 (Programmed cell death protein 1 receptor)

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