Lorviqua shows sustained beneift in 7-year follow up

Progression-free survival reaches 55%...widening gap versus first-generation ALK inhibitors

Shows no new brain metastases after 30 months…safety profile maintained

Pfizer’s non-small cell lung cancer (NSCLC) treatment Lorviqua has demonstrated efficacy in a 7-year follow-up study, confirming its potential for long-term disease control.

According to industry sources on the 30th, Pfizer presented 7-year follow-up results from the Phase III CROWN study of Lorviqua (lorlatinib), a targeted therapy for ALK-positive NSCLC, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

ALK-positive NSCLC is a rare genetic subtype accounting for approximately 3–5% of all NSCLC cases. It tends to affect younger patients and is characterized by a high incidence of central nervous system (CNS) metastases during the course of the disease. As a result, long-term disease control and prevention of brain metastases are considered key measures of treatment success.

Targeted oral therapies for ALK-positive lung cancer include Pfizer’s first-generation Xalkori (crizotinib), second-generation therapies such as Alecensa (alectinib) and Takeda’s Alunbrig (brigatinib), and third-generation Lorviqua.

The global CROWN study directly compared Lorviqua and Xalkori in 296 treatment-naïve patients with advanced ALK-positive NSCLC. Participants were randomly assigned to receive either Lorviqua 100 mg once daily or Xalkori 250 mg twice daily.

‘Lorviqua,’ treatment for ALK-positive NSCLC

Seven-year follow-up results showed that the median progression-free survival (PFS) in the Lorviqua group remained not reached (NR), while the median PFS in the Xalkori group was 9.1 months. This indicates that more than half of patients treated with Lorviqua maintained treatment benefit without disease progression throughout the follow-up period.

At 7 years, progression-free survival rates were 55% in the Lorviqua group versus 3% in the Xalkori group, demonstrating a substantial difference.

In particular, for patients who showed no disease progression up to 24 months after receiving Lorviqua, the probability of surviving without disease progression at the 7-year mark was estimated to be 79%.

Lorviqua also demonstrated a pronounced benefit in preventing brain metastases. No new cases of intracranial disease progression were reported after 30 months of treatment. The median time to intracranial progression was not reached in the Lorviqua group, compared with 16.4 months in the Xalkori group.

Given that ALK-positive NSCLC carries a high risk of brain metastases from early stages and CNS progresses frequently during treatment, durable CNS control is considered highly meaningful in clinical practice.

In terms of safety, the adverse event profile remained comparable with the previously reported 5-year follow-up data. Grade 3 or 4 adverse events occurred in 77% of patients receiving Lorviqua and 57% of those receiving Xalkori. However, permanent treatment discontinuation due to treatment-related adverse events (TRAEs) was relatively low at 5% and 6%, respectively. Furthermore, no new treatment-related permanent discontinuations were reported after 26 months in the Lorviqua group.

Overall survival (OS), however, has not yet reached the pre-specified analysis threshold, and additional follow-up is ongoing. Accordingly, while these results are significant in that they strengthen the evidence for the potential for long-term disease control, further data will be needed to confirm the ultimate survival benefit.