How effective is Lumakras, what's the survival rate?

In a study of people with KRAS G12C mutation-positive non-small cell lung cancer (NSCLC) taking 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, meaning the response lasted longer than 10 months in 50% of people, and less than 10 months in the other half.
• In another lung cancer study, the 12-month progression-free survival rate was 24.8% with Lumakras vs. 10.1% with the chemotherapy agent docetaxel.

In a study evaluating people with KRAS G12C mutation-positive metastatic colorectal cancer (mCRC), people receiving Lumakras plus Vectibex (panitumumab) had improved median progression-free survival (PFS) of 5.6 months compared to 2 months in people receiving the investigator's choice of care.

• Progression-free survival is the length of time during and after cancer treatment that a patient lives with the disease but it does not get worse.
• The study demonstrated an improved overall response rate (ORR) of 26% compared to 0% with investigator's choice.
• The study was not designed to determine overall survival (OS) but showed a trend toward improved OS for patients randomized to Lumakras plus Vectibex.

Clinical studies of Lumakras effectiveness

Lumakras (sotorasib) has been studied in patients with KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) and KRAS G12C-mutated, metastatic colorectal cancer (mCRC).

Your healthcare provider will perform a test to make sure that Lumakras is right for you. You will take Lumakras until your disease worsens or you have intolerable side effects.

NSCLC: CodeBreaK 100 study

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 NSCLS

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).

mCRC: CodeBreaK 300 study

In the CodeBreaK 300 Phase 3, open-label trial in people with KRAS G12C mutation-positive metastatic colorectal cancer (mCRC), people receiving Lumakras plus Vectibex had an improved median progression-free survival (PFS) of 5.6 months compared to 2 months in people receiving the investigator's choice of care (trifluridine/tipiracil or regorafenib). Overall survival data for mCRC are still under investigation.

PFS is the length of time during and after cancer treatment that a patient lives with the disease but it does not get worse.

• Approval was based on the phase III, randomized, open-label CodeBreaK 300 study which compared Lumakras in combination with Vectibix to the investigator's choice of care (trifluridine and tipiracil or regorafenib) in patients with KRAS G12C-mutated mCRC that did not respond to other cancer treatments.
• Results showed that Lumakras plus Vectibix in 53 people showed a significantly improved median PFS of 5.6 months compared to 2 months for 54 patients on investigator's choice of care.
• Researchers did not design the study to look at overall survival (OS), but further evaluation of the study showed a trend toward improved overall survival for patients taking Lumakras plus Vectibix compared to the investigator’s choice of care. The median overall survival (mOS) for patients treated with Lumakras plus Vectibix was not reached and mOS for patients treated with investigator's choice was 10.3 months; the final analysis of OS was not statistically significant.

Related questions

• Is small cell or non-small cell lung cancer worse?
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• How aggressive is non-small cell lung cancer?

Side effects

The most common side effects include diarrhea, musculoskeletal pain, nausea, fatigue, liver toxicity, laboratory abnormalities and cough in people treated for NSCLC.

In people being treated for mCRC combination with Vectibix (panitumumab), the most common side effects are rash, dry skin, diarrhea, stomatitis, fatigue, laboratory abnormalities and muscle / bone pain.

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.

In Jan. 2025, the FDA also approved Lumakras in combination with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

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% of mutations in NSCLC and about 3% to 5% of colorectal cancers.

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.