Amgen Launches Phase 3 Trial of KRAS Inhibitor Sotorasib as First-Line Therapy for Non-Small Cell Lung Cancer in China

The official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform announced,Amgen has launched an international multi-center (including China) Phase 3 clinical trial aimed at evaluatingKRAS inhibitor sotorasib combined with platinum-based doublet chemotherapy.For PD-L1 negative andKRAS p.G12CFirst-line treatment for patients with positive Stage IV or advanced Stage IIIB/C non-squamous non-small cell lung cancerEfficacy and safety. The key Chinese investigator for this study is from Guangdong Provincial People's Hospital.Professor Wu Yilong。

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure

Lung cancer is a common type of cancer and a leading cause of cancer-related deaths.。KRASGene mutations occur in approximately 25% of non-small cell lung cancer (NSCLC) patients, with about 13% carryingKRASG12C mutation.SotorasibIs a specific targetedKRAS G12CCovalent inhibitors of mutants,It works by interacting withKRAS G12CThe mutant binds to KRAS, locking it in an inactive state, thereby irreversibly inhibiting KRAS activity.

In May 2021, the U.S. FDA announcedAccelerated ApprovalsotorasibLaunched for the treatment of patients withKRAS G12CMutatedNon-Small Cell Lung CancerPatient,These patients had received at least one prior systemic therapy.。According to publicly available information,This is the first approved targeted specificKRASAnticancer therapies targeting gene mutations represent a significant milestone in the development of drugs targeting the KRAS point.。

This Phase 3, multicenter, randomized, open-label study (CodeBreaK 202) initiated by Amgen in China is targeted at the indication ofPD-L1 negative,KRAS p.G12CFirst-line treatment for positive advanced/metastatic NSCLC. The purpose of this study is to compare the progression-free survival (PFS) between subjects receiving sotorasib combined with platinum-based doublet chemotherapy and subjects receiving the anti-PD-1 monoclonal antibody pembrolizumab combined with platinum-based doublet chemotherapy.

In September 2023, Amgen announced a project namedCodeBreaK 101Phase 1b/2 Clinical Study Data Evaluating Sotorasib in Combination with Carboplatin and PemetrexedKRAS G12CEfficacy in adult patients with advanced NSCLC harboring mutations. The data shows,In the first-line treatment patients (n=20),The confirmed objective response rate (ORR) was 65%, and the disease control rate (DCR) was 100%.。In evaluable second-line patients (n=13), the ORR was 54% and the DCR was 85%.In patients with PD-L1 expression below 1%, the ORR for first-line treatment was 62%.The ORR for second-line treatment was 50%.With a median follow-up of 3.0 months, rapid and durable responses were preliminarily observed.Progression-Free Survival (PFS）And overall survival (OS) is not yet mature.

Based on the study results, Amgen initiatedsotorasibCombination of Carboplatin and Pemetrexed for First-Line TreatmentKRAS G12CPhase 3 Study of Mutations and PD-L1-Negative Advanced NSCLC (CodeBreaK 202）, which is precisely the clinical study that has just been registered and initiated in China.

Notably, BeiGene has reached a collaboration with Amgen to jointly conduct the development of sotorasib in China.According to publicly available information from BeiGene, sotorasib was previously introduced in the Boao Lecheng Pilot Zone in Hainan.