What Are Zepzelca and Atezolizumab, and Why Do They Matter?
Zepzelca (lurbinectedin) is a chemotherapy medicine that damages the DNA of cancer cells by disrupting their protein function and ability to repair DNA. This action makes it difficult for cancer cells to grow, survive, and spread. Atezolizumab (Tecentriq) is an immunotherapy medication that helps your immune system find and attack cancer cells. The FDA has approved the combined use of these two medicines as first-line maintenance therapy for adults with extensive-stage small-cell lung cancer (ES-SCLC) whose cancer has not worsened after initial immunotherapy (with atezolizumab) and chemotherapy (with carboplatin and etoposide).
ES-SCLC is a fast-growing type of lung cancer that often spreads quickly to vital parts of the body, such as the brain, liver, and bones. Although many patients with ES-SCLC respond well to therapy at first, the cancer usually comes back stronger and is harder to treat. Approval of this maintenance treatment combination can slow down and delay the return of ES-SCLC in patients after their initial treatment.
Why Was the Treatment Approved?
Approval of this combination was based on a clinical study that showed that Zepzelca combined with atezolizumab versus atezolizumab alone helped people live longer and delayed the return of cancer.
The study involved 483 people with ES-SCLC whose cancer had not worsened after initial treatment. People who received Zepzelca plus atezolizumab lived longer (13.2 months vs. 10.6 months) and went longer without their cancer worsening (5.4 months vs. 2.1 months) than those who received atezolizumab alone. The results showed that the combination reduced the risk of the cancer worsening or death by 46% and lowered the risk of death by 27%, compared with atezolizumab alone.
Common side effects of the combination include low counts of white blood cells, red blood cells, and platelets; low hemoglobin levels; nausea; and tiredness or weakness.
Other serious risks include liver damage, muscle breakdown (called rhabdomyolysis), and skin or tissue injury (tissue necrosis) if the medicine leaks outside the veins. Serious and rare life-threatening side effects include very low blood cell counts (myelosuppression), leading to infections, sepsis, bleeding problems, and severe fatigue.
What Do I Need to Know?
Zepzelca is given through an intravenous (IV) infusion every three weeks. Atezolizumab can be given either as an IV infusion or as a shot under the skin, depending on the version used (Tecentriq and Tecentriq Hybreza, respectively). You'll keep getting treatment as long as it's working and the side effects are manageable. To help prevent injury to the surrounding skin or tissues, the medicine is usually given through a central line, which is a special type of IV line placed in a large vein.
Your health care provider may give you other medicines, like granulocyte colony-stimulating factor (G-CSF), to help lower the risk of serious infections caused by low white blood cell counts. You may also be given medicines to prevent nausea and vomiting or make them less severe. During your treatment, you'll need regular blood tests to check your blood cell levels, liver function, and muscle enzyme levels.
Some foods and medicines can affect how Zepzelca works. You should avoid eating grapefruit and Seville oranges and products containing them. If you have serious liver issues, you should not take Zepzelca. Tell your health care provider if you have liver or kidney problems and about all other medicines, over-the-counter products, herbal remedies, and supplements you take to avoid possible reactions. Zepzelca may interact with medicines that affect liver enzymes.
If you are pregnant or breastfeeding, you should not use Zepzelca. It may harm an unborn baby, and breastfeeding should be avoided during treatment and for at least two weeks after your last dose. Those who can become parents should use birth control during treatment and for four months (men) or six months (women) after the last dose.
Contact your health care provider right away if you have a fever or notice any other signs of infection; unusual bruising or bleeding; severe muscle pain or weakness; or pain on the right side of your stomach area (abdomen).