Study suggests that low-fat meals may affect blood concentration levels, and high blood concentration has been correlated with a better response to the drug.
© tortoon stock.adobe.com
Alecensa (alectinib), a second-generation small molecule kinase inhibitor, is a first-line treatment for some patients with advanced nonsquamous non-small cell lung cancer. It has been shown to be very effective, with a response rate of 83% and a median progression-free survival of 35 months, but the effectiveness is tied closely to exposure: The higher the blood concentration, the better the response. In one study, a trough plasma concentration above the threshold (>435 ng/mL) doubled progression-free survival.
Daan A.C. Lanser, M.Sc., of the Erasmus University Medical Center, investigated how the fat content of meals affected blood concentrations of Alecansa (alectinib).
Absorption of Alecensa is largely influenced by food; patients are recommended to take it with a meal. But just how food affects absorption is not entirely known, so Daan A.C. Lanser, M.Sc., and colleagues from Erasmus University Medical Center in Rotterdam conducted the first study to describe an interaction of alectinib with food with different fat percentages. They reported their results this month online in the Journal of the National Comprehensive Cancer Network.
In the study, 20 patients took one of two daily doses of Alecensa with different diets for three periods of seven days each (a new steady-state is formed within seven days, the researchers say). The first dose was taken with either a continental breakfast (two slices of wheat bread with butter and either ham, cheese, or peanut butter, and 250 milliliters (mL) of semi-skimmed milk) at 8 a.m.; 250 grams of low-fat yogurt and 250 mL of water at 8 a.m.; or a self-chosen lunch at 12 p.m. The second dose was taken with a self-chosen dinner at 7 p.m.
Absorption was 14% lower with the low-fat yogurt, compared with the continental breakfast, and 20% less than with the chosen lunch.
The food-drug interaction was clinically relevant and potentially dangerous, the researchers say: Patients with known Ctrough levels close to or below 435 ng/mL are at risk for subtherapeutic exposure and subsequent treatment failure.
Although they only studied low-fat yogurt, the researchers suggest that it’s “probable” that the same issues might arise with other low-fat foods, which could be a quandary for patients concerned about gaining weight (a potential side effect of Alecensa). For those patients, the researchers suggest, Alecensa could be taken with lunch, which typically has a higher fat content .
Combining Avastin With Alecensa Shows Promise in Advanced ALK-Positive Lung Cancer
May 29th 2025A phase 2 trial found that adding bevacizumab to alectinib significantly delayed disease progression, protected against brain metastases, and improved quality of life in patients with advanced ALK-positive lung cancer.
Read More
ICI-Chemo Combo Delivers More Benefit Than Harm, Even for High-Risk NSCLC Patients, Study Finds
May 16th 2025Immune checkpoint inhibitors, such as Opdivo (nivolumab) and Keytruda (pembrolizumab), have been a huge advance in the treatment of non-small cell lung cancer. But it is open question whether they should be combined with traditional chemotherapy.
Read More
Time Well Spent: Lung Cancer Trials Offer Improved Survival Without Added Burden
May 7th 2025Researchers are exploring the topic of "time toxicity" — how much time patients spend receiving care. This study is the first to directly compare time spent in care between clinical trial participants and routine care patients receiving the same treatments.
Read More