A family approach to navigating biomarker-driven lung cancer

(BPT) - For the last few years, Jeff and his wife, Rhonda, have gone to their favorite vacation spot in Destin, Florida. This has become a valued tradition and something they look forward to each year. When they first started this tradition however, they weren’t sure if they’d be able to continue for as long as they have.

“When Jeff was diagnosed with lung cancer, we decided to take a trip for our upcoming anniversary. We didn’t know how many anniversaries we would have together,” recalls Rhonda.

Their apprehensive view of the future began shortly after Jeff went for an annual checkup. At age 57 he was active and worked every day — though he had retired as a firefighter, he still single-handedly ran his 600-acre corn and soybean farm in Ohio. The only thing he had to mention to his doctor at his checkup was a persistent, dry cough.

Concerned about this symptom, his doctor ordered tests which revealed Jeff not only had lung cancer, but the cancer had already metastasized, or spread, to other parts of his body. Following these results, Jeff’s doctor ordered a biopsy of the tumor in his lung to test for genetic mutations, called biomarkers. The results of that test showed that Jeff had a rare type of lung cancer called anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.

“I knew that I had to educate myself on his cancer and become an advocate on his behalf,” says Rhonda. “Our research and my advocacy have helped us to have a good medical team in place that not only supports us but knows us and our goals for Jeff’s treatment.”

Through her research, Rhonda discovered that ALK-positive lung cancer, like Jeff’s, is often treated with biomarker-driven therapies. Armed with this information, she and Jeff asked his doctor to explore prescription medication options that could help them continue to fight his lung cancer.

Because Jeff has responded to his treatments, the trip to Destin, Florida became an annual tradition. “We have gone back every year since then and have taken the same picture in the same spot, drawing the same heart in the sand. It gives us hope and reason to look forward,” says Rhonda.

Jeff started on a biomarker therapy, but after some time, their doctor recommended changing to another. Now, Jeff is taking a biomarker-driven therapy for patients with previously treated disease called LORBRENA^® (lorlatinib).

See below for the LORBRENA indication and Important Safety Information. To learn more about Jeff’s journey, visit LORBRENA.com/patientstories.

Indication

LORBRENA is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC)

• that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and
• that has spread to other parts of the body, and
• who have taken the medicine:
• alectinib, or ceritinib, or
• both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
• that is no longer responding to these treatments.

It is not known if LORBRENA is safe and effective in children.

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Important Safety Information

LORBRENA^® (lorlatinib) may cause serious side effects, including:

• Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
• Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.
• Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most patients will have an increase in the lipid levels in their blood during treatment with LORBRENA.
• If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
• Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
• Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
• Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

• are taking other medications
• have had episodes of depression or seizures
• have high levels of cholesterol or triglycerides in your blood
• have problems with your heartbeat
• have lung or breathing problems
• are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
  • Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.

–Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 6 months after the final dose of LORBRENA. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.

–Males who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA and for at least 3 months after the final dose of LORBRENA.

• are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment with LORBRENA and for 7 days after the final dose. 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 medicines, over-the-counter medicines, vitamins, and herbal supplements.

Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.

The most common side effects of LORBRENA include:

• swelling in your arms, legs, hands, and feet (edema)
• numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
• difficulty thinking or confusion
• difficulty breathing
• tiredness (fatigue)
• weight gain
• pain in your joints
• changes in mood, feeling sad or anxious
• diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Please see Full Prescribing Information and Patient Information.