Drug intelligence / Profile preview

calderasib + pembrolizumab + berahyaluronidase alfa

Development stage
Unknown
Lead developer
Merck
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules, Recombinant Proteins and Enzymes
Administration
Oral, Subcutaneous
01

Overview

Keytruda Qlex + MK-1084 is an investigational combination regimen being developed by Merck (known as MSD outside the US and Canada) in collaboration with Taiho Pharmaceutical and Astex Pharmaceuticals. The regimen consists of two primary components: MK-1084 (calderasib), an oral, highly selective, small-molecule covalent inhibitor of the KRAS G12C mutant protein, and Keytruda Qlex, a subcutaneous fixed-dose combination of the anti-PD-1 monoclonal antibody pembrolizumab and the permeation enhancer berahyaluronidase alfa-pmph. By combining a targeted KRAS G12C inhibitor with an immune checkpoint inhibitor, the regimen aims to simultaneously disrupt oncogenic driver signaling and overcome the immunosuppressive tumor microenvironment. The combination is currently being evaluated in Phase 3 clinical trials, including the KANDLELIT-007 trial (NCT07190248) and the KANDLELIT-013 trial, as a first-line, chemotherapy-free treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation.

Other names
Keytruda Qlex + MK-1084MK-1084 + Keytruda QlexMK-1084 + MK-3475AMK-3475A + MK-1084calderasib + Keytruda Qlexcalderasib + pembrolizumab + berahyaluronidase alfa-pmphcalderasib + pembrolizumab and berahyaluronidase alfacalderasib + pembrolizumab and berahyaluronidase alfa-pmphpembrolizumab + berahyaluronidase alfa + calderasib
02

Targets

KRAS (Kirsten rat sarcoma viral oncogene homolog)PDCD1 (Programmed cell death protein 1 receptor)

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