Clinical Trials | January 11, 2026
Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC
KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
But acquisition charges drag earnings into loss
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
The company will present new data from across over 20 cancer types and multiple treatment settings at European Society for Medical Oncology Congress 2025
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
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