KEY TAKEAWAYS
- The phase II trial aimed to present the updated 3-year follow-up data from the Phase 2 China study.
- The endpoints were ORR, IC-ORR, DOR, IC-DOR, PFS, OS, and safety.
- The result demonstrated that lorlatinib remains effective and safe for Chinese lung cancer patients (even with brain tumors), solidifying its role in their treatment.
Lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) inhibitor, exhibited strong overall and intracranial antitumor efficacy in individuals with advanced ALK-positive non-small cell lung cancer (NSCLC) who had previously received ALK inhibitor therapy.
This was observed in a global phase 1/2 study (NCT01970865) and a multicenter phase 2 study conducted in China (NCT03909971), where researchers presented the updated 3-year follow-up data from the Phase 2 China study.
The study included 109 patients in China diagnosed with ALK-positive locally advanced or metastatic NSCLC. Patients experienced disease progression after crizotinib as the sole ALK inhibitor (cohort 1; n=67) or after one ALK inhibitor other than crizotinib, with or without prior crizotinib (cohort 2; n=42). All participants were administered lorlatinib 100 mg once daily in a continuous 3-week cycle.
Study endpoints were objective response rate (ORR), intracranial ORR (IC-ORR), duration of response (DOR), intracranial DOR (IC-DOR), progression-free survival (PFS), overall survival (OS), and safety.
The median follow-up for progression-free survival (PFS) was 35.9 months in cohort 1 and 33.1 months in cohort 2. In cohort 1, the median PFS (95% CI) by investigator assessment (INV) was 26.3 months (15.2-NR), while in cohort 2, it was 6.9 months (4.2-13.7). The median follow-up for OS was 36.4 months in Cohort 1 and 37.5 months in Cohort 2.
In cohort 1, OS was not reached (NR-NR); in cohort 2, it was 21.9 months (11.9-NR). Long-term treatment did not reveal new safety signals. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 58.7% of patients; no treatment-related deaths were reported.
TRAEs leading to permanent treatment discontinuation, dose interruptions, and dose reductions were reported in 3.7%, 33.0%, and 14.7% of patients, respectively.
The result demonstrated that lorlatinib remains effective and safe for Chinese lung cancer patients (even with brain tumors), solidifying its role in their treatment.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/1014
Clinical Trials: https://clinicaltrials.gov/study/NCT03909971
https://clinicaltrials.gov/study/NCT01970865
Lu S, Zhou Q, Liu X, He S, Zhao H, Li H, Wu Y. Lorlatinib for Previously Treated ALK-positive Advanced NSCLC: Updated Efficacy and Safety Data from a Phase 2 Study in China.
