Julia Rotow, MD, medical oncologist, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, discusses updated data from the phase III ALEX trial in ALK-positive non—small cell lung cancer (NSCLC).

The ALEX trial randomized patients with newly diagnosed ALK-positive NSCLC to receive alectinib (Alecensa) or crizotinib (Xalkori).

Initial results showed an improvement in progression-free survival (PFS) and central nervous system (CNS) activity with alectinib versus crizotinib, says Rotow.

According to 42-month follow-up data which were published in the 

 in May 2019, the median PFS was 34.1 months with alectinib versus 10.2 months with crizotinib. Additionally, alectinib showed superiority over crizotinib in patients regardless of baseline CNS metastases. Overall survival (OS) data are immature, but a trend toward survival benefit was reported with alectinib compared with crizotinib, says Rotow.

At the 2019 ESMO Congress, mature PFS data, as well as updated OS and safety data were presented.

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Julia Rotow, MD, discusses updated data from the phase III ALEX trial in ALK-positive non–small cell lung cancer.

Dr. Rotow on Updated ALEX Trial Results in ALK+ NSCLC

Julia Rotow, MD, medical oncologist, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, discusses the safety profile of brigatinib (Alunbrig) in 

-positive non&shy;—small cell lung cancer (NSCLC).

In 2017, the FDA announced accelerated approval of brigatinib for patients with metastatic 

-positive NSCLC who are resistant to prior crizotinib.

Brigatinib has shown similar toxicity to available ALK TKIs, including gastrointestinal adverse events, explains Rotow. Other toxicities such as elevated blood pressure, creatine phosphokinase, and lipase appear to be more specific to brigatinib, she continues.

Importantly, a pulmonary toxicity syndrome may develop in some patients treated with brigatinib within the first week or so of therapy. This syndrome can present with shortness of breath or infiltrates on lung imaging, Rotow says.

A dose-escalation regimen with brigatinib may mitigate this toxicity, concludes Rotow. Patients should have a 1-week 90 mg lead-dose of the drug, with an increased 180 mg dose given if initial therapy is well tolerated.

Julia Rotow, MD, discusses the safety profile of brigatinib in ALK-positive non–small cell lung cancer.

Julia Rotow, MD

Articles

Dr. Rotow on Updated ALEX Trial Results in ALK+ NSCLC

Dr. Rotow on Brigatinib Safety Profile in ALK+ NSCLC