Brigatinib versus Crizotinib in Anaplastic Lymphoma Kinase (ALK) Inhibitor–Naive Advanced ALK-Positive Non–Small Cell Lung Cancer: Final Results of the Phase 3 ALTA-1L Trial

In the phase 3 ALTA-1L study of brigatinib in anaplastic lymphoma kinase (ALK) inhibitor–naive advanced ALK+ NSCLC, brigatinib demonstrated superior progression-free survival (PFS) versus crizotinib in 2 planned interim analyses. We report final efficacy, safety, and exploratory results. READ ARTICLE

Journal of Thoracic Oncology DOI:10.1016/j.jtho.2021.07.035

Authors: D. Ross Camidge, Hye Ryun Kim, Myung-Ju Ahn, James CH. Yang, Ji-Youn Han, Maximilian J. Hochmair, Ki Hyeong Lee, Angelo Delmonte, Maria Rosario Garcia Campelo, Dong-Wan Kim, Frank Griesinger, Enriqueta Felip, Raffaele Califano, Alexander I. Spira, Scott N. Gettinger, Marcello Tiseo, Huamao M. Lin, Yuyin Liu, Florin Vranceanu, Huifeng Niu, Pingkuan Zhang, Sanjay Popat

Clinical Trials, group4Kirk SmithJuly 30, 2021anaplastic lymphoma kinase, ALK tyrosine kinase inhibitor, brigatinib, crizotinib, non–small-cell lung cancer

Safety and effectiveness of alectinib in a real-world surveillance study in patients with ALK-positive non–small-cell lung cancer in Japan

We conducted a large-scale surveillance study as a post–marketing commitment to investigate the safety and effectiveness of alectinib in patients with ALK-positive non–small-cell lung cancer (NSCLC) in Japan. Patients receiving 300 mg twice-daily alectinib (September 2014 to June 2015) were monitored until termination of alectinib or completion of 18 months of treatment at 519 Japanese study sites. The primary endpoint was the incidence of adverse drug reactions (ADR), which are important identified risks for alectinib in Japanese patients. Overall survival (OS), a key secondary endpoint, was assessed according to information on outcome. Overall, 1251 patients were enrolled. The median patient age was 62.0 years; 12.9% of patients were aged ≥75 years. At baseline, 63.0% of patients had received crizotinib and 40.6% had brain metastases. Altogether, 1512 ADR occurred in 654 patients (53.6%), with 164 grade ≥3 ADR in 123 patients (10.1%). Commonly occurring ADR were hepatic disorders (al..... READ ARTICLE

Cancer Science
DOI:10.1111/cas.13977

Authors: Noriyuki Masuda,Yuichiro Ohe,Akihiko Gemma,Masahiko Kusumoto,Ikuyo Yamada,Tadashi Ishii,Nobuyuki Yamamoto

Clinical TrialsKirk SmithFebruary 18, 2019Alectinib, real-world surveillance, ALK-positive, non–small-cell lung cancer, Japan, UMIN-CTR Clinical Trial number: UMIN000014989