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About Lung Cancer | Diagnosis | Biomarkers

ROS1

A ROS1-positive lung cancer, also known as a ROS1 rearrangement in lung cancer, refers to any lung cancer that tests positive for a fusion in the ROS1 gene. ROS1 rearrangements occur in approximately 1-2% of patients with non-small cell lung cancer (NSCLC). ROS1-positive lung cancer tends to be aggressive and can spread to the brain and the bones.

How the ROS1 Mutation Works

ROS1-positive lung cancer occurs when a gene called ROS1 fuses with a nearby gene. This fusion causes the ROS1 gene to remain stuck in the “on” position. This “drives” abnormal cell growth, which is what cancer is. The ROS1 gene is a receptor tyrosine kinase, a cell surface receptor that has been shown not only to be a key regulator of normal cellular processes, but it also has a critical role in the development and progression of many types of cancer, including lung cancer.

ROS1 is an oncogene, like the ALK oncogene, and, in fact, is related to ALK. According to the National Cancer Institute, an oncogene is a gene that is, under normal circumstances, involved in cell growth, but becomes cancerous if a mutation occurs. Patients with a ROS1 rearrangement respond well to some of the same treatments that are used to treat ALK-positive lung cancer patients.

Dr. David Carbone, of the James Cancer Center at Ohio State University, says, “Immunotherapy has revolutionized lung cancer treatments for many patients.”

However, patients with a ROS1 biomarker driving their cancer are less likely to benefit from immunotherapy than other lung cancer patients. Dr. Carbone recommends starting with ROS1 targeted therapies first. The idea is to continue those as long as they’re working.

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What Does ROS1 Mean?

Lung cancer patient and advocate, Lysa Buonanno, asks Dr. David Carbone, a leading lung cancer expert, the questions important for those living with ROS1-positive lung cancer.

Facts about people who have ROS1-positive lung cancer

People with ROS1-positive lung cancer tend to be:

  • younger than average
  • test negative for other known lung cancer biomarkers such as EGFR and ALK
  • people who have never smoked or only smoked a little.

In addition, compared to other forms of lung cancer, a 2015 study found that:

  • The median age of people with ROS1-positive lung cancer was 50.5. (The median age for lung cancer, in general, is 70.)
  • ROS1-positive lung cancer was slightly more common in women, with 64.5 percent ROS1-positive lung cancer patients being female. (Lung cancer, in general, is slightly more common in men than in women.)

Learn More About ROS1-Positive Lung Cancer

Testing for the ROS1 Mutation

Comprehensive biomarker testing can determine whether an ROS1 lung cancer mutation or another lung cancer mutation is present. If you receive a lung cancer diagnosis, the very first thing you should do is make sure your doctors have ordered comprehensive biomarker testing done on your lung cancer tumor. In addition to having this key testing done, you should have the results before starting any treatment, including chemo and/or immunotherapy.

The comprehensive biomarker testing will involve a biopsy of your lung cancer. This biopsy removes tissue. The tissue is then tested for its genetic makeup, or biomarkers. In most cases, biomarker testing can use the same tissue that was obtained during the original biopsy.  (The biopsy which was used to diagnosing the lung cancer.)

NCI-Designated Comprehensive Cancer Centers and other academic centers are excellent choices for and have experience in comprehensive biomarker testing. You can also have the testing done by a commercial lab recommended by your physician.

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Remember These Important Points to Biomarker Testing

Follow the current guidelines recommended by The National Comprehensive Cancer Network (NCCN).

Follow the current guidelines recommended by The National Comprehensive Cancer Network (NCCN).

These guidelines recommend that your tumor be tested for at least 8 different biomarkers.

NCCN Guidelines

Request this thorough biomarker testing from your physician.

Request this thorough biomarker testing from your physician.

It will offer you the very best options for treatment.

NCCN Guidelines

Wait for all biopsy test results to be returned.

Wait for all biopsy test results to be returned.

Once you have the results, then you should begin recommended treatemnt.

NCCN Guidelines

It is important to have comprehensive biomarker testing.

It is important to have comprehensive biomarker testing.

Knowing your biomarker is key to getting the most effective precision treatments.

NCCN Guidelines

Treatment for the ROS1 Mutation

Once the biomarker testing is complete, and ROS1-positive lung cancer determined, there are some good and effective treatment options available. If your lung cancer hasn’t yet spread and it’s in an early stage, you might be a candidate for surgery to have the lung cancer completely removed. If not, the lung cancer can be treated with a targeted therapy, which is commonly a pill, taken by mouth.

Treatment Options

  • Targeted Therapies

    Effective targeted therapies for ROS1-positive lung cancer include: Crizotinib, Lorlatinib, Entrectinib, Ceritinib, and Repotrectinib

  • Surgery

    If your lung cancer hasn’t yet spread and it’s in an early stage, you might be a candidate for surgery to have the lung cancer completely removed.

  • Radiation

    Radiation therapy slows or stops tumor growth by damaging the DNA and stops cancer cells from dividing and growing. In many cases, radiation therapy kills all of the cancer cells, thus shrinking or eliminating tumors.

  • Chemotherapy

    Chemotherapy for lung cancer treatment uses a drug (or a combination of drugs) that employs cell-killing medications (cytotoxic) to attack cancer cells.

  • Immunotherapy

    Patients with ROS1-positive lung cancer have much less probability of benefiting from immunotherapy than other biomarker driven lung cancers. Immunotherapy might be an option for ROS1-positive lung cancer patients after other options have been exhausted. But the approved targeted therapies for ROS1-positive lung cancer are the best choice for first line treatment.

Clinical Trials

Clinical trials are sometimes great options for patients with ROS1-positive lung cancer. If you are accepted into a clinical trial, you will be assigned to a treatment group. You will either receive an investigational drug or you will be randomized to receive the investigational drug or the best standard of care. The specifics of the clinical trial depend on whether you are in a first-in-human trial or a later phase trial. (Best standard of care is the best treatment that physicians are offering patients with that cancer.)

In addition, the care that is included in the clinical trial will be covered financially by the trial sponsor, and you may receive a new treatment that might become a best option for you. There may also be additional expenses that might not be covered by the trial sponsor, so please carefully read the Informed Consent agreement. Discuss any concerns with a trial coordinator prior to making your decision.

Antidote Match™ connects people with medical research studies, in the fastest and easiest way possible. All you need to do is answer a few questions, and they will find the right trials for you. You gain access to the latest medical developments and world-class care.

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ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

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FDA-Approved ROS1-Positive Lung Cancer Treatments

Types

  • Repotrectinib (Augtyro)

    Repotrectinib (Augtyro) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

    Also used in the treatment of tumors with NTRK gene fusions, Repotrectinib is a next-generation TRK inhibitor approved for patients with NTRK-positive locally advanced or metastatic solid tumors.

    Approved for: NSCLC

    Biomarkers: NTRK, ROS1

    FDA Approval Date: 11/15/2023

    Used in: Targeted Therapy

  • Lorlatinib (Lorbrena)

    Non-small cell lung cancer that is ALK positive and has metastasized (spread to other parts of the body). It is used in patients whose disease got worse after treatment with: Crizotinib and at least one other ALK inhibitor therapy for metastatic disease, or Alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. In March, 2021 also approved to include frontline treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

  • Entrectinib (Rozlytrek)

    Non-small cell lung cancer that is ROS1 positive. It is used in adults whose cancer has metastasized (spread to other parts of the body).

    Approved for: NSCLC

    Biomarkers: ROS1

    FDA Approval Date: 12/21/2024

    Used in: Targeted Therapy

  • Crizotinib (Xalkori)

    Non-small cell lung cancer that is ALK positiveor ROS1 positive and has metastasized (spread to other parts of the body).

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

  • Ceritinib (Zykadia)

    Non-small cell lung cancer that is ALK positive and has metastasized (spread to other parts of the body). It is used in adults.

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

  • David Carbone, M.D., PhD.

    “ROS1 is a gene that is present in everyone’s body. But, the genetic abnormality that drives ROS1-positive lung cancer is only found in the lung cancer tumor. It can't be inherited."

    Dr. David Carbone, James Cancer Center, Ohio State University