How Effective is Lorlatinib?

While exerting the intended therapeutic effects, a medication may also induce certain adverse reactions. Although not all side effects will occur, medical attention may be required if any of them do appear.

How Effective is Lorlatinib?

The CROWN study is a phase Ⅲ, randomized, open-label, parallel-arm clinical trial. A total of 296 treatment-naive patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) were enrolled and randomized at a 1:1 ratio to receive either lorlatinib monotherapy (n=149) or crizotinib monotherapy (n=147). Enrolled patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2 and confirmed ALK-positive NSCLC as detected by the VENTANA ALK (D5F3) companion diagnostic assay.

The primary endpoint of the CROWN study was progression-free survival (PFS) as assessed by blinded independent central review (BICR). The secondary endpoints included overall survival (OS), as well as tumor-related data evaluated by BICR, including objective response rate (ORR) and duration of response (DOR). For patients with measurable central nervous system (CNS) metastases at baseline, additional efficacy endpoints were intracranial objective response rate (IC-ORR) and intracranial duration of response (IC-DOR), both evaluated by BICR.

Side Effects of Lorlatinib

Some side effects may resolve on their own during treatment as the body gradually adapts to the medication, and usually do not require specific intervention. In addition, healthcare providers may offer recommendations to help prevent or alleviate certain side effects. If you experience any of the following side effects that are persistent, bothersome or concerning, it is advisable to consult a healthcare professional in a timely manner. Common side effects include abnormal dreams, back pain, constipation, difficulty moving, difficulty speaking, drowsiness, joint pain, muscle aches, spasms, pain or stiffness, pain in the arms or legs, somniloquy, and joint swelling. It should be noted that some patients may experience other side effects not listed in this document. If you notice any other unusual effects, please also inform your healthcare professional for further guidance.

What Other Information Do I Need to Know?

Be sure to keep all appointments with your doctor and for laboratory tests. Before and during treatment, your doctor will order certain laboratory tests and electrocardiograms to monitor your body’s response to lorlatinib. Your doctor will also check your blood pressure before and during treatment. In addition, before starting treatment, your doctor will arrange for a laboratory test to determine whether your cancer is suitable for treatment with lorlatinib.

Do not share this medication with other people. If you have any questions regarding refills of your prescription medication, please consult your pharmacist.

Keep a written list of all prescription drugs, over-the-counter medicines, vitamins, minerals and dietary supplements you are taking. Bring this list with you every time you visit your doctor or are admitted to a hospital. You should also carry this list with you at all times for emergency situations.