(Lung Cancer) Efficacy of Lorlatinib?

• January 10, 2020
• Reading time: 2 minutes

On October 25, 2019, Alice T. Shaw published results in The Lancet Oncology from a Phase 1/2 clinical trial evaluating the efficacy and safety of lorlatinib — a third-generation ALK tyrosine kinase inhibitor — as monotherapy in ROS1-positive non-small cell lung cancer (NSCLC) patients.

This Phase 1/2 trial was a single-arm, open-label study. Patients with ROS1-positive NSCLC received lorlatinib 100 mg once daily. The primary endpoint was objective response rate (ORR); secondary endpoint was safety.

Efficacy Results:

ORR by prior treatment history:

• Previously treated, TKI-naive patients: 62% (N=21)
• Previously treated with crizotinib: 35% (N=40)

Intracranial response rate:

• Previously treated, TKI-naive patients: 64% (N=11)
• Previously treated with crizotinib: 50% (N=24)

Safety:

The most common Grade 3–4 adverse events were hypertriglyceridemia (19%) and hypercholesterolemia (14%). Although 5 of 69 patients experienced more severe adverse events, no treatment-related deaths were reported.

Based on the Phase 1/2 trial results, Alice T. Shaw concluded that lorlatinib monotherapy demonstrated favorable antitumor activity in ROS1-positive NSCLC patients, including those with brain metastases and those previously treated with crizotinib.

Source: Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1–2 trial (Lancet Oncol. 2019 Oct 25. pii: S1470-2045(19)30655-2. doi: 10.1016/S1470-2045(19)30655-2.)

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