The family of one young cancer patient has a message about genomic cancer testing

(BPT) - Kayley and Shayne Leeds are like most parents. On any given day they juggle work and family, all with the goal of providing a happy and healthy life for their three children. When their middle child Ashton was born, they looked forward to watching him grow and thrive. Ashton’s early years were filled with all the milestones parents hope for — first steps, first words, first day of kindergarten. When Kayley noticed a lump on the side of Ashton’s neck, she thought maybe her 4-year-old son was simply coming down with a cold. When she noticed that the lump was still there a couple of weeks later, she decided it was best to have Ashton see a doctor. There was nothing that could have prepared Kayley and Shayne for what would happen next in their young son’s life.

Ashton’s diagnosis

Ashton’s doctor looked at the lumps on his neck and referred him to an ultrasound. During the course of this appointment, the ultrasound technician started measuring lump after lump on both sides of Ashton’s neck. Due to this abnormal finding, a biopsy was promptly ordered by the doctor. Kayley and Shayne eventually received the call they had been dreading. The doctor called to tell them Ashton had cancer; he’d been diagnosed with Stage IV thyroid cancer. The doctor further explained that it was very rare for a child of such a young age to have the disease so widespread throughout his body. The Leeds were overwhelmed with shock and concern for what lay ahead. He was only 5 years old at this time.

Ashton’s treatment journey

Ashton’s medical team advised that the first treatment would be surgery to remove the bulk of the tumors. After surgery, the plan was to give Ashton two treatments of radioactive iodine. He received the first treatment of radioactive iodine and didn’t require the second treatment until almost a year and a half later. After some time had passed Ashton’s parents noticed that he was having difficulty breathing and took him to see his doctor. It was at that appointment that the doctors could see on Ashton’s chest X-rays that his cancer had spread. His cancer cells were resistant to the radioactive iodine. The Leeds felt they were out of options for their son, but they went forward with the scheduled surgery in hopes it would help. In the hospital, they were approached by the endocrinologist who asked if he could conduct genomic cancer testing on Ashton's tumors in hopes that it would show what was causing his cancer. The Leeds quickly agreed to the testing, holding onto the hope that it may yield some new answers, and it did.

That knowledge may help your doctor recommend treatments that have been approved or are in clinical trials based on the specific genomic alteration identified.

The role of genomic cancer testing

Genomic cancer testing helps doctors match patients to approved or investigational therapies based on what is thought to be causing the patient’s cancer.1 That’s what happened with Ashton — the doctor called to share the news that the test had found an NTRK gene fusion, a rare genomic alteration. The doctor also told them about a study for patients with tumor specimens that also have this specific type of genomic alteration. The Leeds’ were given the opportunity for Ashton to join the clinical trial. Ashton began treatment with VITRAKVI® (larotrectinib). VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that are caused by certain abnormal NTRK genes and have spread or if surgery to remove the cancer is likely to cause severe complications, and there is no acceptable treatment option or the cancer grew or spread on other treatment.2 A healthcare provider will perform a test to make sure that VITRAKVI is right for you. It is not known if VITRAKVI is safe and effective in children younger than 1 month of age.2

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

After a couple of months of being on the study, Ashton’s doctors shared a side-by-side image with the Leeds family that showed CT scans before starting the trial medication and a few months after. The cancer in his lungs had decreased in size, and some spots had totally disappeared. Today, they are sharing their experience to help others.

Patients may experience serious side effects including nervous system or liver problems. The most common side effects of VITRAKVI include tiredness, nausea, dizziness, vomiting, cough, constipation and diarrhea. See below for the full Important Safety Information.

Image of Ashton’s CT scans of his chest before and after treatment.

“Learning that your child has a cancer diagnosis is perhaps the most difficult experience a parent can go through. There is so much uncertainty about the future. It’s an emotional rollercoaster. Our advice to other parents in this situation is to talk to your doctor about genomic cancer testing to learn if it’s an option for your child. Without testing Ashton’s tumor, we never would have learned that he had an NTRK gene fusion, and that there were treatment options like VITRAKVI available,” Kayley Leeds shared.

Today, Ashton likes to build things and he enjoys sports. The Leeds’ describe the journey as an emotional rollercoaster, with many ups and downs. But they say it has all been worth it.

This is the story of one cancer patient’s experience with VITRAKVI® (larotrectinib). Not all patient experiences will be the same.

VITRAKVI was studied in 3 separate clinical trials. The studies looked at how many patients with solid tumors had a response to treatment with VITRAKVI. The primary analysis included 55 patients whose tumor had an NTRK gene fusion from these clinical trials. A response means that the cancer reduced in size by at least 30% or completely disappeared. 41 of 55 (75%) patients had a response to treatment. 22% (12 patients) had a complete response, which means that their target tumors completely disappeared, and 53% (29 patients) had a partial response, which means that their target tumors reduced in size by 30% or more. There was 1 pediatric patient with a type of cancer called unresectable infantile fibrosarcoma who had a partial response and was able to undergo surgery. The patients remained disease free when the study data was analyzed.

What is VITRAKVI®?

VITRAKVI (larotrectinib) is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

  • are caused by certain abnormal NTRK genes and
  • have spread or if surgery to remove their cancer is likely to cause severe complications, and
  • there is no acceptable treatment option, or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

It is not known if VITRAKVI is safe and effective in children younger than 1 month of age.

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

Important Safety Information

VITRAKVI may cause serious side effects, including:

  • Nervous system problems. Tell your healthcare provider if you develop any symptoms such as confusion, difficulty speaking, dizziness, coordination problems, tingling, numbness, or burning sensation in your hands and feet. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop symptoms of a nervous system problem with VITRAKVI.
  • Liver problems. Your healthcare provider will do blood tests to check your liver function during treatment with VITRAKVI. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop liver problems with VITRAKVI.

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

  • have liver problems
  • have nervous system (neurological) problems
  • are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. You should not become pregnant during treatment with VITRAKVI.
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you.
    • Males with female partners who are able to become pregnant should use effective birth control during treatment with VITRAKVI and for at least 1 week after the final dose of VITRAKVI.
  • are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VITRAKVI
  • VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

While on VITRAKVI, you should avoid:

  • driving or operating machinery until you know how VITRAKVI affects you. VITRAKVI can make you feel dizzy.
  • taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Certain other medicines may affect how VITRAKVI works.

The most common side effects with VITRAKVI include:

  • Tiredness
  • Nausea
  • Dizziness
  • Vomiting
  • Cough
  • Constipation
  • Diarrhea

These are not all the possible side effects with VITRAKVI. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For full prescribing information, visit: http://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf

References:

  1. National Foundation for Cancer Research. Cancer Genomics. https://www.nfcr.org/genomics/. Accessed February 2020.
  2. VITRAKVI [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2019.

© 2020 Bayer. Bayer, the Bayer Cross and Vitrakvi are registered trademarks of Bayer.

PP-VIT-US-0184-3

06/20

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