Biomarker Testing in Lung Cancer

TRACY LAND was a healthy, active 45-year-old woman when she started to feel terrible back pain that led to a devastating lung cancer diagnosis.

When her back problems began, Tracy had just moved her family of four into a new home and frequently enjoyed water sports. As a result, her pain seemed explainable and she thought little of it.

More than a year later, and after receiving several steroid shots to no avail, Tracy’s doctor ordered a set of scans. They revealed tumors in her lung that had also spread in her bones and spine. She was sent for a bronchoscopy, ​which confirmed she had stage IV non-small cell lung cancer (NSCLC).

NSCLC is the most common type of lung cancer, present in up to 85% of all cases. Over the past two decades, targeted therapies have become available for patients with certain types of NSCLC. This class of medicines works by targeting the specific drive​r of the cancer’s growth, providing another alternative to chemotherapy and immunotherapy as a patient’s first treatment.

Tracy’s oncologist recommended a biomarker test to see if they should consider a targeted therapy. The test revealed that Tracy’s cancer was caused by a change in the RET gene, which is found in up to 2% of NSCLC tumors.

Importance of Biomarker Testing

There are currently nine NSCLC biomarkers that can be treated with an approved medicine, which translates to about 50% of patients being eligible for targeted therapy.

“By helping identify appropriate patients for targeted trea​tments, biomarker testing can have an important impact on patient care,” said Jennifer C. King, PhD, Chief Scientific Officer at GO2 Foundation for Lung Cancer. “Studies have shown that these therapies can improve outcomes for patients with lung cancer.”

With comprehensive testing approaches, such as next-generation sequencing, patients can get assessed for multiple biomarkers at once. Biomarker test results take up to two weeks to come back, but it can be worth the wait if there is the opportunity for patients to benefit from a targeted therapy.

Pursuing a RET-Targeted Treatment

Upon hearing the results of the biomarker test, Tracy’s family urged her to understand her medical options. After speaking with multiple doctors, Tracy decided to enroll in a clinical trial for a RET-targeted treatment – today known as GAVRETO^® (pralsetinib).​

FDA approved in 2020, GAVRETO is a prescription medicine used to treat adults with NSCLC caused by abnormal rearranged during transfection (RET) genes and that has spread to other parts of the body. A healthcare provider will perform a test to make sure that GAVRETO is right for the patient.

Impact of GAVRETO for Tracy

Tracy’s prognosis has improved since enrolling in the clinical trial. While everyone’s experience is different, Tracy’s doctors noticed she responded to treatment two months into the study. Tracy takes GAVRETO capsules once a day in the morning. She works closely with her healthcare team to help manage side effects, including nausea and low white blood cell counts, while she is on treatment.

Although Tracy’s life has changed since her cancer diagnosis, she remains active. She loves being on the water, bakes pumpkin bread and other treats through her small business, and prioritizes time with her family and friends.

Tracy stated, “I feel fortunate that my doctors identified the genetic change that caused my cancer, so that from the start, I could be treated with a therapy targeted for my tumor type. I encourage others to speak to their doctors and advocate for biomarker testing to inform treatment decisions.”

For more information, speak with your doctor and visit GAVRETO.com.

IMPORTANT SAFETY INFORMATION

GAVRETO^® (pralsetinib) 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 problems 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 you to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well hydrated during treatment with GAVRETO. Call your healthcare provider or get emergency medical help right away if you 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. Tell your healthcare provider if you plan to have any surgery before or during treatment with GAVRETO. You should not take GAVRETO for at least 5 days before surgery. Your healthcare provider should tell you when you may start taking GAVRETO again after surgery.​​

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

• ​​​​have lung or breathing problems other than lung cancer
• have high blood pressure
• have bleeding problems
• have liver problems
• plan to have surgery
• are pregnant or plan to become pregnant. GAVRETO can harm your unborn baby.
  ​ Females who are able to become pregnant:​​​​
  • Your healthcare provider will do a pregnancy test before you start GAVRETO.
  • Should use an effective form of non-hormonal birth control (contraception) during treatment with GAVRETO and for 2 weeks after your last 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.
  • Talk to your healthcare provider about birth control methods that may be right for you during this time.
  • Tell your healthcare provider right away if you become pregnant or think you 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 your last dose of GAVRETO.​​​​
• are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of GAVRETO.

​​​​Tell your healthcare provider about al​l the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking GAVRETO with other medicines may affect how GAVRETO works.

The most common side effects of GAVRETO include: muscle and joint pain, constipation, diarrhea, tiredness, swelling of your face, arms, legs, hands, and feet (edema), fever, and cough.

The most common severe abnormal blood tests results with GAVRETO include: decreased white blood cell, red blood cell, and platelet counts, decreased levels of phosphate, body salt (sodium), calcium and potassium, abnormal liver function, increased levels of enzyme called alkaline phosphatase, and increased levels of potassium.

GAVRETO may affect fertility in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of GAVRETO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please click here to see the full Prescribing Information and Patie​nt Information for GAVRETO

Thi​s content was developed by Blueprint Medicines Corporation and Genentech, Inc., the manufacturers of GAVRETO.

Blueprint Medicines, GAVRETO and associated logos are trademarks of Blueprint Medicines Corporation.

 M-US-00014039(v2.0) 09/23​  ​

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