(Lung Cancer) Is Next-Generation ALK Inhibitor Ensartinib Effective?

• January 1, 2020
• Reading time: 2 minutes

On October 15, 2019, Yunpeng Yang published results in The Lancet Respiratory Medicine from a Phase II clinical trial evaluating ensartinib monotherapy in ALK-positive non-small cell lung cancer (NSCLC) patients with crizotinib resistance, assessing its efficacy and safety.

This Phase II trial was a single-arm, open-label study conducted in ALK-positive NSCLC patients with crizotinib resistance (N=160). Patients received ensartinib 225 mg once daily. The primary endpoint was objective response rate (ORR); secondary endpoints included safety. Of the 160 patients, 62% (N=97) had brain metastases at baseline.

Results:

Among evaluable patients, the primary endpoint ORR was 52%. Among evaluable patients with brain metastases, the ORR was 70%.

Safety:

At least one adverse event was reported in 91% of patients (145/160). The most common adverse events were skin disorders (56%, N=89), ALT elevation (46%, N=74), and AST elevation (41%, N=65).

Based on the Phase II clinical trial results, Yunpeng Yang concluded that ensartinib monotherapy demonstrated favorable antitumor activity in crizotinib-resistant, ALK-positive NSCLC patients, including those with brain metastases. Further clinical trials are warranted to confirm its utility.

Source: Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial (Lancet Respir Med. 2019 Oct 15. pii: S2213-2600(19)30252-8. doi: 10.1016/S2213-2600(19)30252-8.)

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