Lorviqua (Lorlatinib) Approved In EU For First-Line Treatment Of ALK-Positive Non-Small Cell Lung Cancer
Pfizer Inc. recently announced that its third-generation anaplastic lymphoma kinase (ALK) inhibitor Lorviqua (generic name: Lorlatinib) has been approved by the European Commission
As a monotherapy for the first-line treatment of adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC) who have not been treated with an ALK inhibitor.
Recent Research Advances In Lorviqua
Lorviqua is an orally administered small molecule inhibitor of ROS1 and ALK developed specifically to inhibit the most common tumor mutations driving resistance to current drugs and to address brain metastases at the most common site of disease progression in ALK-positive NSCLC.
Key Study Data
The CROWN study: a head-to-head phase 3 study conducted in 296 patients with advanced ALK+ NSCLC who had not received prior therapy, evaluating the efficacy and safety of first-line treatment with Lorviqua and crizotinib.
Results showed that Lorlatinib treatment significantly reduced the risk of disease progression or death by 72% compared to crizotinib (HR=0.28, p<0.001).
In addition, in patients with measurable brain metastases, Lorviqua treatment significantly improved intracranial remission rates (objective remission rate [ORR]: 82% vs. 23%; complete remission rate [CR]: 71% vs. 8%), and a significantly higher proportion of patients with intracranial duration of remission (IC-DOR) ≥12 months (79% vs. 0%).
5-YEAR FOLLOW-UP DATA: In the 5-year follow-up data from the CROWN study, median PFS remained unmet in the Lorviqua group, with a 5-year PFS rate of 60%, further confirming the long-term efficacy of Lorviqua.
Key Clinical Data
The CROWN trial demonstrated that Lorviqua reduced the risk of disease progression or death by 72% compared to existing second-generation ALK inhibitors (e.g., crizotinib, alectinib). In addition
Brain Metastasis Control Rate: For patients with brain metastases at baseline, Lorviqua achieved an intracranial objective remission rate (ORR) of 82%, far exceeding that of the control group.
Long-term efficacy: median progression-free survival (PFS) has not been reached, compared to 9.3 months in the control group.
About Lorviqua
Third-generation ALK/ROS1 tyrosine kinase inhibitor designed to overcome resistance to its predecessors.
It has previously been approved in the US (2018) and Japan (2021), but this EU extension to a first-line indication signals early benefit for a wider range of patients.
Future Outlook
The head of Pfizer’s global oncology division said the company is exploring the use of Lorviqua in combination with other therapies, such as immune checkpoint inhibitors, to further improve survival outcomes.
However, DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.
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