Reference: August 2025 | Issue 8 | Vol 11 | Page 5
For the first time, a large prospective randomised trial has demonstrated that a 14-gene molecular assay can identify patients with high-risk non-squamous non-small cell lung cancer (NSCLC) who could benefit from adjuvant chemotherapy.
Preliminary, non-randomised clinical data have suggested that the 14-gene expression profile, RiskReveal, is effective in identifying patients with stage IA-IIA non-squamous NSCLC who benefit from adjuvant therapy. At ASCO 2025, researchers presented the early interim findings of an international, multicentre, randomised clinical trial.
This study enrolled 421 patients with stage IA-IIA non-squamous NSCLC post-resection. Tumours were categorised as low, intermediate,or high risk using the RiskReveal assay. At the time of this interim analysis, there were 194 intermediate- and high-risk patients who could be evaluated.
Patients who were categorised as intermediate or high risk were randomised to receive four cycles of platinum-based adjuvant chemotherapy (n=87) or to observation (n=107). Researchers then compared the time to disease recurrence in each group.
After 24 months, patients who received adjuvant chemotherapy had a 78 per cent lower risk of cancer recurrence compared to the observation group. In the adjuvant chemotherapy group, 96 per cent of patients did not have a cancer recurrence. In the observation group, 79 per cent of patients did not have a cancer recurrence. The median disease-free survival endpoint was not reached in either group.
The authors reported that at the time of the interim analysis, the Data Safety Monitoring Board had recommended that enrolment be discontinued given the effectiveness with which the assay determined which patients could benefit from adjuvant chemotherapy. Follow-up continues with those who were already enrolled.
Reference
Spigel D, Westeel V, Anderson I, et al. An international, multicentre, prospective randomised trial of adjuvant chemotherapy for stage Ia-IIa non-small cell lung cancer identified as high risk by a 14-gene molecular assay. Abstract #LBA8027. American Society of Clinical Oncology Annual Meeting. May 30-June 3, 2025. Chicago, US.
