Immutep Quarterly Activities Report Q1 FY24 - Seite 2

TACTI-002 (KEYNOTE-PN798)
Phase II clinical trial evaluating efti + KEYTRUDA (pembrolizumab)

1st line Non-Small Cell Lung Cancer (1L NSCLC)

Following the end of the quarter, Immutep reported excellent Overall Survival results from efti in combination with KEYTRUDA in patients with metastatic NSCLC at the ESMO Congress 2023 in Spain in October.

Exceeding expectations, median Overall Survival has reached 35.5 months in NSCLC patients expressing PD-L1 (patients with a Tumour Proportion Score (TPS) of ≥1%), 23.4 months in patients with low PD-L1 expression (TPS 1-49%) and encouragingly, has not yet been reached in patients with high PD-L1 expression (TPS ≥50%).

A 35.5-month survival benefit gives these patients 12 to 18 months of additional survival compared to historical data from the current best approved option: pembrolizumab in combination with doublet chemotherapy (see Table 1). In addition to the substantial survival benefit, the combination of efti and pembrolizumab is chemo-free, avoiding the toxic side effects seen in chemo options. Efti is enabling deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile in line with anti-PD-1 monotherapy.

Table 1: Overall Survival of Efti + KEYTRUDA versus standard-of-care Immuno-Oncology (IO), IO-IO, IO-chemo, and IO-IO-chemo therapies for 1st line treatment of advanced non-small cell lung cancer patients with PD-L1 TPS ≥1%

Therapy	Median Overall Survival1
Efti + Pembrolizumab	35.5 months
Pembro + Doublet Chemo (NSQ)*	23.3 months
Pembro + Doublet Chemo (SQ)*	18.9 months
Ipilimumab + Nivolumab2	17.1 months
Pembrolizumab monotherapy2	16.4 months
Ipi + Nivo + 2 cycles Doublet Chemo	15.8 months

* NSQ = Non-squamous; SQ = Squamous

TACTI-003 – Phase IIb clinical trial in 1st line HNSCC
The Phase IIb TACTI-003 trial is ongoing in patients with 1st line HNSCC. Patient recruitment reached ~99% in October and is expected to be complete in November 2023. The primary analysis according to the trial protocol will be performed after all subjects in the randomized part have completed at least three cycles of treatment (18 weeks in total) or discontinued the trial. The Company expects to report data from the trial in H1 CY2024.