Benzinga | Nov 18, 2021 04:57PM EST

Immutep Says Successfully Completes Recruitment For Phase II TACTI-002 Study Of LAG-3 Therapy, Eftilagimod Alpha

SYDNEY, AUSTRALIA -- 19 November 2021 -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep"

or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments

for cancer and autoimmune disease, announces the last patient has been enrolled in the expansion stage

of Part A of its Phase II TACTI-002 study (also designated KEYNOTE-798). The Company announced that

the TACTI-002 study has completed recruitment of patients across all cohorts.

A total of 185 patients are now participating in TACTI-002 across Parts A, B, and C (see Table 1) at 20

clinical sites in Australia, Europe, and the US.1 Notably, recruitment into the expansion stage of Part A was

completed faster than anticipated, with all patients in this stage being recruited in under 12 months.

As announced previously, further interim data from Part C (2nd line HNSCC) was presented at the Society

for Immunotherapy of Cancer (SITC) Annual Meeting 2021, which took place from 10-14 November 2021.

Further data from TACTI-002 (including from Part A) will be reported in the first half of calendar year 2022.

Immutep CEO, Marc Voigt commented: "The completion of recruitment for our Phase II TACTI-002 trial

marks the achievement of a major milestone for Immutep. Our clinical team and partners have worked

hard to continue the pace of patient enrolment and finished recruitment much earlier than originally

anticipated, despite some challenging conditions brought on by the COVID-19 pandemic. We are excited

to be reporting further results from this trial in the coming months. We sincerely thank the patients and

their families, and our various partners, for their ongoing support of this important trial."

Table 1 -- TACTI-002 Recruitment (as at 18 November 2021)

Stage 1 (N)

Actual / Target

Stage 2 (N)

Actual / Target

Expansion Stage

Actual / Target

Recruitment

Status

Part A (1st line NSCLC) 17/17 19/19 74/741 COMPLETE

Part B (2nd line NSCLC) 23/23 13/13 - COMPLETE

Part C (2nd line HNSCC) 18/18 21/192 - COMPLETE

1 Up to 5 additional patients may be recruited into the expansion stage of Part A meaning the total number of patients may be more than originally

planned as there are still patients currently in screening. 2 2 extra patients were treated as allowed under the trial protocol since 2 patients had dropped out due to Covid-19 prior to first post-baseline

staging.



Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889



About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc.,

Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the

combination of eftilagimod alpha (efti) with MSD's KEYTRUDA(r) (pembrolizumab) in patients with second

line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical

study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

* Part A - First line Non-Small Cell Lung Cancer (NSCLC), PD-X na?ve - given the promising results of

the first two stages of Part A, an expansion stage with 74 additional patients was commenced in

November 2020 to assist with trial design in subsequent late-stage settings

* Part B - Second line NSCLC, PD-X refractory

* Part C - Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X na?ve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to

pembrolizumab monotherapy especially in NSCLC and HNSCC.

More information about the trial can be found on Immutep's website or on ClinicalTrials.gov (Identifier:

NCT03625323)