We Asked an Oncologist: What Might Someone with ROS1+ Non-Small Cell Lung Cancer Need to Know?

The ROS1+ lung cancer patient doesn’t look like your “typical” lung cancer patient. People with this form of lung cancer tend to be younger, and typically have little or no history of smoking.

Dr. Rajat Thawani at the University of Chicago shares more about ROS1+ NSCLC and shares advice for newly diagnosed patients.

When a patient is diagnosed with lung cancer, how would they know it’s ROS1+ NSCLC?     

To determine a ROS1+ NSCLC diagnosis, the patient would need to undergo something called biomarker testing.

Biomarker testing is how doctors discover important factors that may be driving someone’s cancer, like a gene mutation or fusion in the case of ROS1. This testing is done by checking a blood or tissue sample for certain genes, proteins or other markers.

The results of biomarker testing can help determine a patient’s treatment options. For instance, if someone is determined to have ROS1+ NSCLC, their treatment options are different and may include targeted therapies known as tyrosine kinase inhibitors, or TKIs.

Can you tell us more about the latest treatment option available for ROS1+ NSCLC patients? 

We’ve known about ROS1 mutations in NSCLC for quite some time but treating these patients has been challenging. Fortunately, there has been scientific research in this area. There were limited options at the end of 2023, until the FDA approved a treatment option called Augtyro, also known as repotrectinib.

Augtyro is an oral prescription medicine used to treat NSCLC in adults that has spread within the chest or to other parts of the body and is caused by an abnormal ROS1 gene.

Augtyro is not chemotherapy— it’s a targeted ROS1 treatment which means it zeroes in on ROS1 proteins. Most types of targeted therapies like Augtyro help fight specific proteins that cause tumors to grow and spread throughout the body.

It’s important to remember that every patient responds differently.

Augtyro may cause serious side effects, including central nervous system effects (CNS), lung problems (pneumonitis), liver problems, muscle problems, increased uric acid level in your blood (hyperuricemia), and bone fractures. Patients should talk to their doctors about what’s right for them.

What research led to the approval of this treatment?

The FDA approval is based on the results from a clinical trial called TRIDENT-1.

• This study looked at Augtyro in patients with locally advanced or metastatic solid tumors harboring ROS1, including NSCLC.
• The study included both patients who had never been treated with a TKI, known as TKI-naïve, as well as those who had been treated with a prior TKI, known as TKI-pretreated.
• Of the 71 patients who were TKI-naïve, 73% saw their tumors shrink and 6% saw their tumors disappear.
• For those patients whose tumors did respond, either partially or completely, the median length of time before that tumor grew or spread – otherwise known as the median duration of response – was 34.1 months.
• For the 56 patients treated with other TKIs before (TKI pre-treated patients) in the trial, 32% saw their tumors shrink and 5% had their tumors disappear.
• The disappearance of many measurable tumors in response to treatments does not necessarily mean the cancer has been cured.

ROS1+ NSCLC can spread to the brain. Did the research reveal anything about patients who experienced this kind of metastasis?

Yes, the trial also assessed the effects of Augtyro in patients whose cancer had spread to their brain before entering the study but did not have symptoms.

• In this assessment, we used a measure called intracranial response. This is defined as the number of patients showing a decrease in the size of their brain tumor or the disappearance of signs of cancer in the brain following treatment.
• Among those who had cancer that spread to the brain at the start of the trial, responses in intracranial lesions were observed in 7 of 8 TKI-naïve patients and 5 of 12 of those who were TKI-pretreated.

The most common side effects of Augtyro include constipation; shortness of breath; tiredness; trouble with balance, coordination, and walking; problems with thinking, such as forgetfulness or confusion, memory problems and hallucinations; muscle weakness; and nausea. But these are not all the possible side effects of Augtyro. Please see the Important Safety Information and talk to your doctor for more information.

What excites you about this treatment option for patients?

This form of lung cancer remains difficult to treat and can often spread to the brain, so having a next-generation treatment option in our toolbox for both TKI-naive and TKI-pretreated patients is very important.

Speak to your doctor about Augtyro as a potential treatment option.

What advice would you give to someone recently diagnosed with ROS1+ NSCLC?

Hearing the words, “you have cancer” is overwhelming, and there is often a lot for a patient to learn about ROS1+ NSCLC. Treatment decisions may need to happen quickly, and this can be difficult to navigate and process. I advise patients:

• Bring a trusted friend or family member to appointments. This can help ensure you understand your treatment options, which is key for decision-making and for helping reduce anxiety.
• Have regular and candid discussions with your doctor and care team about your treatment goals and options. Cancer treatment is constantly evolving, so staying receptive to new information is important.
• Lastly, there are resources available to help you through this journey, including support groups and educational materials. Advocacy groups, like ROS1ders and the Lung Cancer Research Foundation, can help connect patients to these resources.

For more information please visit, www.augtyro.com.

INDICATION

AUGTYRO® (repotrectinib) is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread within your chest or to other parts of the body and is caused by an abnormal ROS1 gene.

It is not known if AUGTYRO is safe and effective in children with ROS1-positive NSCLC.

IMPORTANT SAFETY INFORMATION

AUGTYRO® (repotrectinib) may cause serious side effects, including:

Central nervous system (CNS) effects. Tell your healthcare provider right away if you experience any new or worsening symptoms of CNS effects during treatment with AUGTYRO, including:

• dizziness
• vertigo
• changes in mood, such as anxiety, irritability, and depression
• balance or coordination problems
• problems with thinking, such as forgetfulness or confusion
• seeing or hearing things that are not real (hallucinations)
• problems with concentration, attention, memory, and sleep

Lung problems (pneumonitis). Tell your healthcare provider right away if you have any new or worsening lung problems, including a dry cough (without mucus), productive cough (with mucus), wheezing, or trouble breathing.

Liver problems. Your healthcare provider will do blood tests to check your liver function before starting treatment with AUGTYRO, every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you develop symptoms of liver problems including: your skin or the white part of your eyes turns yellow, dark or “tea-colored” urine, light-colored stools (bowel movements), loss of appetite, nausea or vomiting, pain on the upper right side of your stomach area.

Muscle problems. Your healthcare provider will do blood tests before starting treatment with AUGTYRO, every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Increased uric acid level in your blood (hyperuricemia). AUGTYRO may cause an excess of uric acid in your blood. Your healthcare provider will do tests before and during your treatment with AUGTYRO to check the uric acid level in your blood. Your healthcare provider may prescribe medications if you have high blood uric acid levels. Tell your healthcare provider if you experience symptoms of increased uric acid including:

• red, hot, tender, or swollen joints, especially in your big toe
• pain in your stomach-area or sides
• decrease in your amount of urine or no urine at all
• nausea or vomiting
• pink or brown urine or blood in your urine

Bone fractures. AUGTYRO may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider right way if you have pain, changes in movement, or bone abnormalities.

Before taking AUGTYRO, tell your healthcare provider about all your medical conditions, including if you:

• have nervous system (neurological) problems.
• have lung or breathing problems other than lung cancer.
• have liver or kidney problems.
• are pregnant or plan to become pregnant. AUGTYRO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AUGTYRO.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with AUGTYRO.
  • You should use effective non-hormonal birth control (contraception) during treatment and for 2 months after the last dose of AUGTYRO.
  • Birth control methods that contain hormones (such as birth control pills, injections or transdermal system patches) may not work as well during treatment with AUGTYRO.
  • Talk to your healthcare provider about birth control methods that may be right for you.

  Male patients with female partners who are able to become pregnant:

  • You should use effective birth control during treatment with AUGTYRO and for 4 months after the last dose.
• are breastfeeding or plan to breastfeed. It is not known if AUGTYRO passes into your breast milk. Do not breastfeed during treatment and for 10 days after the last dose of AUGTYRO. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Taking AUGTYRO with certain other medicines may affect the amount of AUGTYRO or other medicines in your blood and may cause side effects or affect the way that AUGTYRO or other medicines work. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking AUGTYRO?

• You should not drink grapefruit juice or eat grapefruit during your treatment with AUGTYRO. It may increase the amount of AUGTYRO in your blood to a harmful level.
• Do not drive or operate machinery until you know how AUGTYRO affects you. If you experience dizziness, blurred vision, memory loss, changes in mental status, confusion, hallucinations or have trouble with balance or coordination or problems with concentration and attention, do not drive or operate machinery until your symptoms have resolved.

The most common side effects of AUGTYRO include: dizziness; change in sense of taste; feeling of numbness or tingling in your arms or legs; constipation; shortness of breath; tiredness; trouble with balance, coordination, and walking; problems with thinking, such as forgetfulness or confusion, memory problems and hallucinations; muscle weakness; and nausea.

These are not all the possible side effects of AUGTYRO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Patient Information for AUGTYRO. Talk to your healthcare team for more information about this medication.

© 2024 Turning Point Therapeutics, Inc., a Bristol Myers Squibb Company.

AUGTYRO™ and the related logo are trademarks of Turning Point Therapeutics, Inc.

 

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