LUMAKRAS® (sotorasib) Dose Comparison Study Results

Today, during an ESMO Plenary Virtual Session, Amgen presented data from the LUMAKRAS® (sotorasib) 960 mg versus 240 mg dose comparison study in pretreated patients with KRAS G12C advanced non-small cell lung cancer (NSCLC). These data were previously provided in our publicly available Oncology Drugs Advisory Committee briefing book in early October.

Based on the totality of data across the global CodeBreaK clinical development program and post marketing data, LUMAKRAS 960 mg once daily provides a more favorable benefit-risk profile for patients living with KRAS G12C-mutated cancers.

Data from the dose comparison study demonstrated that LUMAKRAS 960 mg resulted in a numerically higher response rate and longer median overall survival compared to the 240 mg dose for patients with previously treated NSCLC patients with the KRAS G12C mutation. These data are further supported by the CodeBreaK 300 study of LUMAKRAS plus Vectibix® (panitumumab) versus investigator's choice in KRAS G12C mCRC patients, where the 960 mg dose showed more clinical benefit than the 240 mg dose.

LUMAKRAS at 960 mg once daily is currently the approved dose globally. We will continue to work with regulatory agencies on the path forward.

LUMAKRAS® (sotorasib) U.S. Indication

LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).



Amgen Inc. published this content on 16 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 November 2023 00:34:08 UTC.