Dr Horinouchi on Safety Data for Adjuvant Alectinib in ALK+ NSCLC

“Based on the results from the ALINA trial, adjuvant treatment [with alectinib] is 1 of the new standard treatment strategies for the 

-positive NSCLC after complete resection.”

Hidehito Horinouchi, MD, PhD, professor, oncologist, the National Cancer Center Hospital, Tokyo, Japan, discusses 

safety findings from the phase 3 ALINA trial

 (NCT03456076) evaluating the adjuvant alectinib (Alecensa) compared with platinum-based chemotherapy in patients with resected 

-positive non–small cell lung cancer (NSCLC).

In this multicenter trial, the safety analysis included 128 patients in the alectinib arm and 120 in the chemotherapy arm. Any-grade adverse effects (AEs) were observed in 98% of patients treated with alectinib vs 93% of those treated with chemotherapy. The rates of grade 3/4 AEs were 30% and 31%, respectively. Grade 3/4 treatment-related AEs occurred in 18% and 28% of patients in the alectinib and chemotherapy arms, respectively.

Treatment modifications were more common in the alectinib arm, with AEs leading to dose reductions, dose interruptions, and treatment discontinuations occurring in 26%, 27%, and 5% of patients, respectively. In the chemotherapy arm, these respective rates were 10%, 18%, and 13%. Despite these adjustments, the median treatment duration for alectinib was 23.9 months, which was consistent with the planned protocol duration.

Horinouchi highlight that the most frequent AEs in the alectinib arm were laboratory abnormalities, including elevated levels of blood creatine phosphokinase (CPK), aspartate aminotransferase, alanine aminotransferase, and bilirubin. These laboratory findings were predominantly asymptomatic, minimizing their clinical impact, he says. Although elevated CPK levels was the most common abnormality, only 5.5% patients required dose modifications due to these AEs.

Horinouchi emphasizes that the safety profile of alectinib in this adjuvant setting aligns with previously reported data in the advanced setting, underscoring its tolerability. The low discontinuation rate and manageable toxicity profile make alectinib a feasible option for long-term adjuvant therapy in ALK-positive NSCLC, he concludes.

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Hidehito Horinouchi, MD, PhD, discusses safety data for adjuvant alectinib vs chemotherapy in ALK-positive non–small cell lung cancer.

Hidehito Horinouchi, MD, PhD

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Dr Horinouchi on Safety Data for Adjuvant Alectinib in ALK+ NSCLC