Immutep reports 30.9-month median survival in Phase I NSCLC combination trial
The company also disclosed differing immune activation data from the discontinued TACTI-004 Phase III study, with root cause findings due in Q3 CY2026.
Immutep Limited announced on July 13, 2026 mature overall survival results from its investigator-initiated Phase I trial, INSIGHT-003, testing eftilagimod alfa alongside Merck's pembrolizumab (KEYTRUDA) and chemotherapy in previously untreated non-squamous non-small cell lung cancer.
At a data cutoff of March 27, 2026 and with at least 30 months of follow-up, the trial's 51 evaluable patients reached a median overall survival of 30.9 months in the overall population regardless of PD-L1 expression, with the same figure observed in the 47 patients with TPS below 50% and 37.8 months in the four patients with TPS at or above 50%.1 About 92% of enrolled patients had no or low PD-L1 expression, a group the company described as having significant unmet medical need.1 The company noted these results compare favourably to the 22.0 month median overall survival from a registrational trial of anti-PD-1 plus doublet chemotherapy in the same non-squamous 1L NSCLC setting.1 No new safety signal was identified since the previous data cutoff.1
Separately, Immutep provided an update on TACTI-004, a Phase III trial in 1st line NSCLC that the company discontinued in March 2026 after an Independent Data Monitoring Committee recommended stopping following a planned interim futility analysis.1 In that trial's futility analysis of 173 patients, the objective response rate was 42.9% in the efti arm versus 55.1% in the control arm receiving standard of care plus placebo.1
The company reported preliminary immune monitoring data from TACTI-004 showing a markedly different immune activation profile in efti-treated patients, based on absolute lymphocyte counts and circulating monocyte counts,1 which contrasted with results from nearly 600 patients across five earlier efti studies and with the INSIGHT-003 data.1 Additional analysis covering all evaluable TACTI-004 patients who received at least 12 weeks of treatment is ongoing, with further results expected in the third quarter of calendar year 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.