After almost 40 years of research, the first KRAS-targeted therapy has been approved. The drug sotorasib (Lumakras) is an inhibitor of the RAS GTPase family.

Sotorasib was approved by the FDA on May 28, 2021. It is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy. Diagnosis is determined by an FDA-approved test in patients who had disease progression  after receiving an immunotherapy or chemotherapy. Available in 120 mg tablets, 960 mg of sotorasib is taken by mouth daily.

The approval of sotorasib was based on results from the CodeBreak 100 trial, in which 124 locally advanced or metastatic NSCLC patients with KRAS G12C mutations were administered sotorasib 960 mg orally daily until disease progression. In these patients, their cancer had previously progressed during or after chemotherapy, immunotherapy, or both.

One primary outcome in the study was the objective response rate (ORR), which was 36% (95% CI: 28%, 45%), with the other primary outcome being a median response duration of 10 months. Furthermore, 81% of patients attained disease control, which was defined as the number of patients who achieved complete response, partial response, and stable disease lasting 3 or more months.

Diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough were the most common adverse reactions, occurring in 20% or more of patients. Laboratory anomalies occurring in 25% or more of patients included lymphocytopenia, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Share your thoughts about the efficacy of sotorasib and how this may affect how you test and treat NSCLC.

Sources:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf

https://www.amgen.com/newsroom/press-releases/2021/05/fda-approves-lumakras-sotorasib-the-first-and-only-targeted-treatment-for-patients-with-kras-g12cmutated-locally-advanced-or-metastatic-nonsmall-cell-lung-cancer

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc

After almost 40 years of research, the first KRAS-targeted therapy has been approved. The drug sotorasib (Lumakras) is an inhibitor of the RAS GTPase family.

Sotorasib was approved by the FDA on May 28, 2021. It is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy. Diagnosis is determined by an FDA-approved test in patients who had disease progression  after receiving an immunotherapy or chemotherapy. Available in 120 mg tablets, 960 mg of sotorasib is taken by mouth daily.

The approval of sotorasib was based on results from the CodeBreak 100 trial, in which 124 locally advanced or metastatic NSCLC patients with KRAS G12C mutations were administered sotorasib 960 mg orally daily until disease progression. In these patients, their cancer had previously progressed during or after chemotherapy, immunotherapy, or both.

One primary outcome in the study was the objective response rate (ORR), which was 36% (95% CI: 28%, 45%), with the other primary outcome being a median response duration of 10 months. Furthermore, 81% of patients attained disease control, which was defined as the number of patients who achieved complete response, partial response, and stable disease lasting 3 or more months.

Diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough were the most common adverse reactions, occurring in 20% or more of patients. Laboratory anomalies occurring in 25% or more of patients included lymphocytopenia, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Share your thoughts about the efficacy of sotorasib and how this may affect how you test and treat NSCLC.

Sources:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf

https://www.amgen.com/newsroom/press-releases/2021/05/fda-approves-lumakras-sotorasib-the-first-and-only-targeted-treatment-for-patients-with-kras-g12cmutated-locally-advanced-or-metastatic-nonsmall-cell-lung-cancer

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc