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David was in his thirties and living a healthy life when doctors discovered a cancerous mass in his neck. He began treatment immediately, unsure about the journey ahead, and after enduring several therapies that left him feeling worse, his thyroid cancer was still spreading. Luckily, through a support group, David’s wife Kathleen discovered that he could have his tumor tested to see if it had a specific genetic alteration.
This kind of test is known as biomarker testing, which may identify genetic “drivers” that are causing cancer to grow and spread and can help patients and their doctors make more informed treatment decisions. As David experienced, a cancer diagnosis can lead to emotional distress stemming from the unknowns around what comes next. Fortunately, medical advancements like comprehensive biomarker testing can potentially unlock information to help address some of these uncertainties and provide a roadmap for next steps.
Comprehensive biomarker testing is no longer just an option, it is a critical step to guide many patients’ treatment. Results from comprehensive biomarker tests can help doctors determine which treatments or clinical trials may be most appropriate. They can also help determine which therapies may or may not be effective based on the biomarker. Identifying these “drivers” is an important step in informing a treatment plan, especially for patients like David, who may be at a critical moment in their journey.
“We encourage the patients we support to discuss biomarker testing with their physicians as soon as possible after diagnosis,” says Aliye Bricker, founder of RETpositive, a patient advocacy group for people whose cancers are driven by an abnormal RET gene. “Awareness of — and access to — timely and comprehensive biomarker testing is critical for the patient journey and can provide key information that may ultimately impact their treatment options and outcomes.”
Unfortunately, many people with advanced cancer still don’t receive biomarker testing. In fact, according to the American Cancer Society, only 39% of people with cancer who responded to a recent survey reported having biomarker testing completed.1
Here are some key facts about biomarker testing that can help determine if it may be beneficial:
Biomarkers are found in a variety of cancers.
Biomarkers can be found in common cancers like breast and colorectal cancer, as well as rarer tumor types. Of the 1 million people worldwide diagnosed with adenocarcinoma, the most common lung cancer, approximately half have biomarkers that can be acted upon with a targeted therapy.2 For this reason, anyone diagnosed with any type of advanced cancer should talk to their doctor about whether biomarker testing might be helpful.
Biomarker testing can reveal many different biomarkers.
Comprehensive biomarker testing can check for recommended biomarkers based on clinical guidelines to help healthcare professionals understand more about a person’s specific type of cancer. It’s important to note that not everyone who gets tested will have tumors with an identifiable biomarker that can be targeted with a treatment. Comprehensive biomarker results are also critical to match patients with clinical trials – whether as their first course of treatment, or when other options aren’t working.
The techniques used in biomarker testing are evolving.
A healthcare professional can conduct a biopsy to remove tissue from a tumor for testing, which is the most common method. Tests can now also identify a wide range of cancer biomarkers at once instead of one at a time. In lung cancer, a less invasive biomarker test called a “liquid biopsy” may be used to identify genetic alterations through blood.
The importance of biomarker testing before starting treatment.
Biomarker testing is the only way to identify if a person could potentially benefit from certain treatments, so it is critical to talk about it with a care team as soon as they learn they have advanced cancer. Depending on the location of the tumor and type of test, biomarker testing can be done at a doctor’s office, hospital, or testing facility. Results from biomarker tests take about two weeks to come back; it’s important for a patient to talk with his or her doctor about waiting for this information so it can help inform their treatment decision.
In David’s situation, his cancer was positive for RET.
David was eligible to join a clinical trial for GAVRETO, also known as pralsetinib, developed specifically to target his RET+ cancer. People with certain cancers identified with RET alterations may consider this treatment option, which is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of RET-positive metastatic non-small cell lung cancer and advanced thyroid cancer.
For more information about biomarker testing, please visit https://www.biomarkertesting.com.
What is GAVRETO® (pralsetinib)?
• GAVRETO is a prescription medicine used to treat certain cancers caused by abnormal rearranged during transfection (RET) genes in• adults with non-small cell lung cancer (NSCLC) that has spread
• adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy)
• adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working
It is not known if GAVRETO is safe and effective in children younger than 12 years of age.
A patient’s healthcare provider will perform a test to make sure that GAVRETO is right for them.
GAVRETO was approved 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 GAVRETO.
IMPORTANT SAFETY INFORMATION
GAVRETO may cause serious side effects, including:
Lung Problems: GAVRETO may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including shortness of breath, cough, or fever.
High blood pressure (hypertension): High blood pressure is common with GAVRETO and may sometimes be severe. You should check your blood pressure regularly during treatment with GAVRETO. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including confusion, dizziness, headaches, chest pain or shortness of breath.
Liver problems: Liver problems (increased liver function blood test results) can happen during treatment with GAVRETO and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment with GAVRETO to check you for liver problems. Tell your healthcare provider right away if you get any signs or symptoms of liver problem during treatment, including yellowing of your skin or the white part of your eyes (jaundice), loss of appetite, nausea or vomiting, dark “tea-colored” urine, pain on the upper right side of your stomach area, sleepiness, bleeding or bruising.
Bleeding problems: GAVRETO can cause bleeding which can be serious and cause death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment, including vomiting blood or if your vomit looks like coffee-grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or brown urine, drowsiness or difficulty being awakened, red or black (looks like tar) stools, confusion, coughing up blood or blood clots, headache, unusual bleeding or bruising of your skin, change in speech, or menstrual bleeding that is heavier than normal.
Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause patients to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. A healthcare provider may do blood tests to check patients for TLS. Patients should stay well hydrated during treatment with GAVRETO. Patients should call their healthcare provider or get emergency medical help right away if they develop any of these symptoms during treatment with GAVRETO: nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures or swelling.
Risk of wound healing problems: Wounds may not heal properly during treatment with GAVRETO. Patients should tell their healthcare provider if they plan to have any surgery before or during treatment with GAVRETO. Patients should not take GAVRETO for at least 5 days before surgery. A healthcare provider should tell patients when they may start taking GAVRETO again after surgery.
Before taking GAVRETO, patients should tell their healthcare provider about all of their medical conditions, including if they:
• have lung or breathing problems other than lung cancer
• have high blood pressure
• have bleeding problems
• plan to have surgery
• are pregnant or plan to become pregnant. GAVRETO can harm an unborn baby.
Females who are able to become pregnant:
• A healthcare provider will do a pregnancy test before patients start GAVRETO.
• Should use an effective form of non-hormonal birth control (contraception) during treatment with GAVRETO and for 2 weeks after the final dose of GAVRETO.
• Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with GAVRETO.
• Patients should talk to their healthcare provider about birth control methods that may be right for them during this time.
• Patients should tell their healthcare provider right away if they become pregnant or think they might be pregnant during treatment with GAVRETO.
Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after their final dose of GAVRETO.
• are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes into breast milk. Patients should not breastfeed during treatment and for 1 week after their last dose of GAVRETO.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GAVRETO may affect the way other medicines work, and other medicines may affect how GAVRETO works.
The most common side effects of GAVRETO include constipation, decreased levels of phosphate in the blood, high blood pressure, decreased levels of calcium in the blood, tiredness, decreased levels of body salt (sodium) in the blood, muscle and joint pain, diarrhea, abnormal liver function blood tests, and decreased white blood cell, red blood cell, and platelet counts.
GAVRETO may affect fertility in males and females, which may affect a patient’s ability to have children. Patients should talk to their healthcare provider if this is a concern for them.
These are not all of the possible side effects of Gavreto. Patients should call their doctor for medical advice about side effects. Patients are encouraged to report side effects to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088.
Please see the full Prescribing Information and Patient Information for Gavreto.
This content was developed by Blueprint Medicines Corporation and Genentech, Inc.
References:
• American Cancer Society: Cancer Action Network. (2020, September). Survivor Views: Biomarker Testing. American Cancer Society.
• Kris, M. G. et al (2014). Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA, 311(19). https://doi.org/10.1001/jama.2014.3741.
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