Amgen announced on the 15th that it has released phase 3 clinical data of ‘Lumacras®’ (ingredient name: Sotorasim), a target treatment for KRAS G12C-mutated non-small cell lung cancer, a lung cancer mutation that is taken orally.
Compared to docetaxel, an intravenous chemotherapy treatment, the company explained that it significantly improved the objective response rate (ORR: primary clinical evaluation index) as well as excellent progression-free survival (PFS: primary clinical evaluation index). In particular, in this clinical trial, patient-reported results (PROs: major secondary clinical evaluation indicators) were also confirmed to be improved compared to docetaxel.
This data was disclosed as a late-breaker oral presentation at the Presidential Symposium III session of the 2022 European Society for Oncology (ESMO) symposium held in Paris, France on the 12th local time.
Dr David Rees, Executive Vice President of Amgen R&D, said, “The clinical evidence confirmed through this study comprehensively supports that Lumacras is an important targeted treatment for patients with KRAS G12C-mutated non-small cell lung cancer, as well as for all advanced lung cancer patients. “This reinforces the importance of comprehensive genetic diagnostic testing.”
Lumakras demonstrated superior progression-free survival in all clinically relevant subgroups, including those with a history of brain metastasis at baseline. The proportion of patients with progression-free survival at 1 year was 25% for Lumacross and 10% for docetaxel.
Lumacross showed a significantly higher objective response rate (28% Lumacross vs. 13% docetaxel) in the administration group compared to the docetaxel administration group.
Other clinical usefulness-related secondary clinical evaluation indicators showed overall consistent clinical benefit. Specifically, the disease control rate (DCR: Lumacross 83% vs. docetaxel 60%) was improved. The time to treatment response was faster (Lumakras 1.4 months vs. docetaxel 2.8 months), and the duration of response was longer (Lumakras 8.6 months vs. docetaxel 6.8 months).
For overall survival (OS: main secondary endpoint), there was no significant difference between the two treatment groups (Lumakras 10.6 months vs. docetaxel 11.3 months).
Melissa L. Johnson, Lung Cancer Research Director, Sarah Cannon Institute, Tennessee Oncology, Tennessee Oncology, who was responsible for the presentation, said, “In addition to consistent improvement in progression-free survival in all clinically relevant subgroups, including patients with a history of brain metastases, In particular, it is very encouraging that the response rate of Lumacross was more than twice that of docetaxel.”
Meanwhile, Lumakras is the only approved KRAS G12C inhibitor in the world. It has been approved in 44 countries including the United States, Europe, the United Kingdom and Japan, including Korea.
Reporter Jang Bom-i [email protected]
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