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Lorlatinib Effectiveness and Quality-of-Life in Patients with ALK-Positive NSCLC Who Had Failed Second-Generation ALK
Martin Rupp1, Fiorella Fanton-Aita1, Stephanie Snow2
1Pfizer Canada, 17300 Trans-Canada Hwy, Kirkland, QC H9J 2M5, Canada.
Abstract:
Lorlatinib is the only targeted therapy approved in Canada to treat patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose tumor has progressed despite treatment with second-generation ALK tyrosine kinase inhibitor (TKI), a patient population with high unmet need and lack of publicly reimbursed targeted treatments in Canada. We prospectively examined the real-world effectiveness and impact of lorlatinib on quality-of-life in 59 lorlatinib-treated patients, characterized as: median age of 62.0 years; 47.5% were female; 32.2% had central nervous system metastases; 50.8% had 2+ prior ALK TKI lines; and alectinib was the most common ALK TKI (72.9%) administered before lorlatinib, including 44.1% who received first-line alectinib. With a median follow-up of 15.3 months (IQR: 6.2-19.2), median time-to-treatment discontinuation of lorlatinib was 15.3 months (95% CI: 7.9-not reached), with 54.2% (95% CI: 40.8-65.9%) of patients without treatment discontinuation at 12 months. At baseline, the mean health utility score (HUS) was 0.744 (SD: 0.200). At 3 months, patients receiving lorlatinib demonstrated a 0.069 (95% CI: 0.020-0.118; p = 0.007) average HUS increase over baseline; HUS was maintained at 6 and 12 months. Thus, patients with ALK-positive NSCLC post second-generation ALK TKI remained on lorlatinib for a meaningful duration of time while their quality-of-life was preserved.
Insights
Lorlatinib effectively treats advanced ALK-positive NSCLC after second-generation TKI therapy, showing durable responses and preserved quality-of-life in Canadian real-world data. This targeted therapy addresses a significant unmet need for patients with this specific lung cancer subtype.
Area of Science:
- Oncology
- Pharmacology
- Public Health
Background:
- Lorlatinib is the sole approved targeted therapy in Canada for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) progressing after second-generation ALK tyrosine kinase inhibitor (TKI) treatment.
- This patient population faces high unmet needs and limited publicly reimbursed targeted treatment options in Canada.
- Real-world data on lorlatinib's effectiveness and quality-of-life impact in this specific context are crucial.
Purpose of the Study:
- To prospectively evaluate the real-world effectiveness of lorlatinib in patients with ALK-positive NSCLC who have progressed on prior ALK TKI therapy.
- To assess the impact of lorlatinib treatment on patients' quality-of-life, measured by health utility scores (HUS).
- To characterize the patient population receiving lorlatinib in Canada, including prior treatment history and baseline characteristics.
Main Methods:
- Prospective observational study involving 59 patients treated with lorlatinib for ALK-positive NSCLC.
- Data collected on patient demographics, treatment history (including prior ALK TKIs like alectinib), and clinical outcomes.
- Quality-of-life assessed using health utility scores (HUS) at baseline and at 3, 6, and 12 months post-treatment initiation.
Main Results:
- The median time to treatment discontinuation for lorlatinib was 15.3 months, with 54.2% of patients remaining on treatment at 12 months.
- Patients demonstrated a statistically significant average increase in health utility score (HUS) of 0.069 at 3 months compared to baseline (p=0.007).
- This improvement in HUS was maintained at 6 and 12 months, indicating preserved quality-of-life during treatment.
Conclusions:
- Lorlatinib provides a meaningful duration of treatment for patients with ALK-positive NSCLC following second-generation ALK TKI therapy in a real-world Canadian setting.
- Treatment with lorlatinib is associated with preserved or improved quality-of-life, as indicated by stable health utility scores over 12 months.
- Lorlatinib represents a valuable therapeutic option for this patient group with high unmet needs.
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