TACTI-003 (KEYNOTE-PNC34) – Phase IIb clinical trial in 1st
line HNSCC
Enrolment was completed for the TACTI-003 trial in November 2023. A total of 171 first line head
and neck squamous cell carcinoma (1L HNSCC) patients have been enrolled in this randomized, multicenter Phase IIb trial evaluating efti in combination with pembrolizumab in 138 patients with PD-L1 positive
(Combined Positive Score [CPS] ≥1) tumors (Cohort A) and in 33 patients with PD-L1 negative tumors (Cohort B).
The primary endpoint of the study is ORR of evaluable patients according to RECIST 1.1. Secondary endpoints include OS, ORR according to iRECIST, PFS, and
DoR. Patients in Cohort A whose tumors express PD-L1 (CPS >1) are stratified by CPS 1-19 and CPS >20, and the clinical results for these CPS groups, as well
as for patients in Cohort B with CPS <1, will be evaluated.
Immutep expects to report first data from
TACTI-003 in H1 CY2024.
AIPAC-003 – Integrated Phase II/III trial
in Metastatic Breast Cancer
The Company completed the safety lead-in portion of the AIPAC-003 trial evaluating for the first time 90mg of efti in combination with paclitaxel in 6 patients during the quarter. The treatment was well tolerated with no dose limiting toxicities. This good safety profile
enabled the lead-in phase to be closed after the first 6 patients. Following the recommendation of the independent Data Monitoring Committee (IDMC), the Company proceeded into the randomized Phase II portion
of study and is currently dosing patients. Currently 18 patients have been dosed in the randomized part.
TACTI-004 – Phase III registrational trial in 1L NSCLC
Immutep received constructive regulatory feedback from the Paul-Ehrlich-Institut (PEI), a German regulatory authority and part of the Committee for Medicinal
Products for Human Use (CHMP), regarding the planned TACTI-004 trial of efti for 1L NSCLC in December. The PEI is supportive of Immutep moving ahead with the registrational trial evaluating efti in combination
with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Also, the PEI acknowledged the good safety
profile of efti in combination with anti-PD-1 therapy.
Additional
interactions with the FDA, other local European regulators, as well as with other stakeholders and potential partners are ongoing. Immutep plans to announce the final trial design for TACTI-004 in Q1 of
CY2024.
INSIGHT-003 – Phase I in 1L NSCLC
Promising efficacy and tolerability data was presented from the INSIGHT-003 trial at the ESMO Congress 2023 in October.
The trial evaluates efti plus anti-PD-1 therapy and doublet chemotherapy as first line therapy in non-squamous NSCLC patients. A
strong ORR of 71.4% was reported, along with a Disease Control Rate of 90.5% and a 10.1-month median PFS. Median OS has not been reached, despite 81% of patients having low or negative PD-L1 expression.
In the
difficult-to-treat PD-L1 TPS <50% patient population (i.e. those with cold or tepid tumors), the triple combination achieved a
high 70.6% response rate and median PFS that exceeded 10 months in both low (TPS 1-49%) and negative (TPS<1%) PD-L1 patients, which collectively represent roughly 70%
of the overall NSCLC patient population and remain an area of high unmet need.