Trial-first for Roche lung cancer ALK inhibitor

Roche’s Alecensa^® (alectinib) is the first anaplastic lymphoma kinase (ALK) inhibitor to demonstrate a reduction in the risk of disease recurrence or death for patients with early-stage ALK-positive non-small cell lung cancer (NSCLC) in a Phase III trial.

The Phase III ALINA study compared Alecensa to platinum-based chemotherapy.

Results from the trial “provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” stated Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development at Roche. “If approved, Alecensa has the potential to treat cancer before it has spread.”

Roche’s oral treatment met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Overall survival (OS) data were immature at the time of the analysis.

Yet the positive results from the Phase III trial build on the treatments already-established benefit for advanced cases of NSCLC.

Alecensa is approved in countries such as the US, Europe, Japan and China as an initial treatment for ALK-positive, metastatic NSCLC. However, there are no approved ALK inhibitors for early-stage ALK-positive disease, according to research highlighted by Roche.

The data from the Phase III ALINA trial will be presented at an upcoming medical meeting.

Recently, in late August 2023, Roche’s Tecentriq^® (atezolizumab) was the first subcutaneous anti-PD-(L)1 cancer immunotherapy to be approved for patients in Great Britain. It was the first cancer immunotherapy approved for a certain type of early-stage NSCLC.

Focusing on oncology, Roche also gained approval from the European Commission (EC) in July this year, for its bispecific antibody indicated to treat diffuse large B-cell lymphoma (DLBCL).

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