Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Shots:

• The US FDA has granted BTD to Merck‘s calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%)
• Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while combination of calderasib + Keytruda & CT achieved an ORR of 53%
• Calderasib is a KRAS G12C covalent inhibitor, which is being assessed in the KANDLELIT program, which incl. 5 P-III trials across a range of tumor types & stages 

Ref: Businesswire  |  Image: Merck  | Press Release

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