Primary completion results from a Phase 3 study evaluating lazertinib as a first-line treatment for EGFR mutation positive locally advanced or metastatic non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2022-07-29. The trial demonstrated that lazertinib achieved a median progression-free survival (PFS) of 20.6 months, compared to 9.7 months for gefitinib.
Background
This study investigated lazertinib as a first-line treatment for patients diagnosed with EGFR mutation positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This patient population typically benefits from targeted therapies that address the specific EGFR mutations driving their cancer.
Trial design
The Phase 3 study (NCT04248829), known as LASER301, enrolled 393 participants with EGFR mutation positive locally advanced or metastatic non-small cell lung cancer. The trial aimed to evaluate the efficacy and safety of lazertinib as a first-line treatment. Participants were randomized to receive either lazertinib 240 mg or gefitinib 250 mg, with corresponding placebos for blinding. Key outcomes measured included Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), Disease Control Rate (DCR), and Overall Survival (OS).
Key results
The trial reported the following key efficacy measurements by investigator assessment:
- Progression-Free Survival (PFS): The median PFS for the lazertinib 240 mg group was 20.6 Months. For the gefitinib 250 mg group, the median PFS was 9.7 Months.
- Objective Response Rate (ORR): The ORR for lazertinib 240 mg was 76.0 Percentage of participants. For gefitinib 250 mg, the ORR was 76.1 Percentage of participants.
- Duration of Response (DoR): The median DoR for the lazertinib 240 mg group was 19.4 Months. For the gefitinib 250 mg group, the median DoR was 8.3 Months.
- Disease Control Rate (DCR): The DCR for lazertinib 240 mg was 93.9 Percentage of participants. For gefitinib 250 mg, the DCR was also 93.9 Percentage of participants.
- Overall Survival (OS): For the lazertinib 240 mg group, 49 participants were reported out of 147 participants assessed for overall survival. For the gefitinib 250 mg group, 64 participants were reported out of 133 participants assessed.
What this means
The results of the LASER301 study indicate that lazertinib significantly prolonged median progression-free survival compared to gefitinib in patients with EGFR mutation positive locally advanced or metastatic NSCLC, extending it to 20.6 months from 9.7 months. This suggests a substantial improvement in disease control. While Objective Response Rate and Disease Control Rate were comparable between the two treatments, the longer Duration of Response for lazertinib (19.4 months vs. 8.3 months for gefitinib) further supports its potential to provide more sustained benefits. These findings position lazertinib as a potentially superior first-line treatment option for this specific patient population, offering a longer period without disease progression.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The primary completion results for the study NCT04248829, titled "Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)", were posted on 2022-07-29 on clinicaltrials.gov.