Immutep Quarterly Activities Report Q1 FY24 - Seite 3

TACTI-004 – Phase III registrational trial in 1st line NSCLC
Throughout the quarter, Immutep continued its preparations to commence the TACTI-004 trial. The trial is expected to start in CY2024.

AIPAC-003 – Integrated Phase II/III trial in Metastatic Breast Cancer
Patient recruitment into the AIPAC-003 trial continued throughout the quarter with 15 clinical sites now actively recruiting. Six patients were enrolled and have completed the dose limiting toxicity (DLT) window of the first cycle in the open-label safety lead-in portion. The safety evaluation of the six patients is underway with the Independent Data Safety Monitoring Committee (IDMC) review meeting planned for beginning of November 2023. If no dose limiting toxicities are observed in those six patients, the randomized dose optimization (Phase II) part can start in Q4 CY2023.

INSIGHT-003 – Phase I in 1st line NSCLC
At the ESMO Congress 2023 in October, further encouraging efficacy and tolerability data was presented from the ongoing investigator-initiated INSIGHT-003 trial evaluating efti plus anti-PD-1 therapy and doublet chemotherapy as 1st line therapy in metastatic non-squamous non-small cell lung cancer.

A strong Overall Response Rate of 71.4% and 90.5% Disease Control Rate were reported. Median Overall Survival (OS) has not yet been reached. The median Progression Free Survival (PFS) was 10.1 months.

In this study, 81% of patients have low or negative PD-L1 expression, making them typically less responsive to anti-PD-1 based therapy. For low or negative PD-L1 expressors (TPS <50%), the ORR was 70.6% which compares favourably to reported results from a registrational trial of anti-PD-1 and doublet chemotherapy that yielded a response rate of 40.8% in the same patient population.

INSIGHT-005 – Phase I trial in Urothelial Carcinoma
Following receipt of regulatory approvals to initiate INSIGHT-005, preparations to commence this investigator-initiated trial are continuing at the Frankfurt Institute of Clinical Cancer Research, IKF.

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
The first soft tissue sarcoma (STS) patient was enrolled and safely dosed in the Phase II EFTISARC-NEO trial in July. The trial is the first chemo-free triple combination therapy of efti and is the first to evaluate it in a neoadjuvant setting. STS is an orphan disease with high unmet medical need and poor patient prognosis. Currently six patients have been recruited into this trial which is funded by a Polish grant program.