How effective is Lumakras, what's the survival rate?
In one clinical study with Lumakras, 45 out of 124 people (36%) saw their non-small cell lung cancer (NSCLC) tumors disappear or decrease in size by at least 30%. The median duration of response was 10 months. In another study, the 12-month progression-free survival rate was 24.8% with Lumakras vs. 10.1% with the chemotherapy agent docetaxel.
Effectiveness of Lumakras
In a study of 124 patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) receiving 960 mg of Lumakras orally once per day, 36% of people (45 people) saw their tumors shrink (by at least 30%) or disappear.
- Two people had tumors disappear and 43 had their tumors shrink. The median duration of response was 10 months, with close to 60% of patients responding for at least 6 months.
- In addition, 44% of people (55 patients) had their tumors remain stable, not growing by 20% or more or shrinking by 30% or more. Overall, Lumakras treatment led to smaller tumors or suppressed tumor growth in 81% of patients.
The FDA approved Lumakras (sotorasib) for treatment of NSCLC under an "accelerated approval". This means that continued approval may depend upon results of further clinical studies looking at its effectiveness for this use.
Survival rate with Lumakras
In another study presented at the 2022 European Society of Medical Oncology Congress, the 12-month progression-free survival rate at a median of 17.7 months was 24.8% with Lumakras compared with 10.1% with the chemotherapy agent docetaxel (Taxotere).
Progression-free survival is the length of time a patient lives from the start of a study to disease progression or death.
In this study, patients lived on average 1.1 months longer with Lumakras compared to docetaxel (5.6 months vs. 4.5 months, respectively).
When was Lumakras approved?
Amgen’s Lumakras (sotorasib) received FDA accelerated approval in May 2021 for adults with non-small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy.
In clinical studies, healthy volunteers responded to Lumakras, but further studies are ongoing to determine overall effectiveness. Lumakras is also being studied in other solid tumor types.
You will take Lumakras until your disease worsens or you have intolerable side effects. The most common side effects include diarrhea, muscle pain or body aches, nausea, tiredness, liver damage and cough. Serious liver damage and lung scarring / inflammation may also occur.
The recommended dose is 960 mg by mouth once daily. Your doctor may need to change your dose if you have side effects like liver or lung toxicity, severe nausea or vomiting, severe diarrhea or other side effects. In some cases, your doctor may decide you need to stop treatment.
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What is KRAS G12C?
KRAS is a protein found in the body that signals cells to grow or to stop growing. If you’ve had a test that shows you have a KRAS G12C mutation, this means that the KRAS protein has been changed (mutated) and does not function normally. KRAS G12C tells the KRAS protein to stay active, which can lead to uncontrolled tumor growth.
Lumakras was the first targeted therapy for cancers with any KRAS mutation. KRAS G12C mutations account for about 13% (1 in 8) of mutations in NSCLC.
This is not all the information you need to know about Lumakras (sotorasib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.
References
- Ryan MB, Corcoran RB. Therapeutic strategies to target RAS-mutant cancers. Nat Rev Clin Oncol. 2018 Nov;15(11):709-720. doi: 10.1038/s41571-018-0105-
- Hong DS, Fakih MG, Strickler JH, et al. KRAS G12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239
- Lumakras (sotorasib) prescribing information. Amgen Inc. Thousand Oaks, CA. Accessed Jan. 25, 2023 at https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Lumakras/lumakras_pi_hcp_english.pdf
- FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Drugs.com. May 28, 2021. Accessed Jan. 25, 2023 at https://www.drugs.com/newdrugs/fda-approves-lumakras-sotorasib-kras-g12c-mutated-locally-advanced-metastatic-non-small-cell-lung-5533.html
- Lumakras.com Amgen. About KRAS G12C. Accessed Jan. 25, 2023 at https://www.lumakras.com/about-kras-g12c
- Inman S. Lumakras Improves Outcomes, Quality of Life in Patients With Lung Cancer Subtype. CureToday. Sept. 14, 2022. Accessed Jan. 25, 2023 at https://www.curetoday.com/view/lumakras-improves-outcomes-quality-of-life-in-patients-with-lung-cancer-subtype
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