Benzinga | Nov 19, 2021 08:02AM EST

Immutep Reports Successfully Completed Recruitment For Phase 2 TACTI-002 Study Of LAG-3 Therapy

* Enrolled and dosed last patient in the expansion stage of Part A (1st line non-small cell lung cancer (NSCLC)) needed to complete recruitment into all cohorts of the TACTI-002 study

* Interim data from Part C (2nd line head & neck squamous cell carcinoma (HNSCC) patients) presented at SITC 2021

* Additional data from TACTI-002 expected to be reported in H1 calendar year 2022

SYDNEY, AUSTRALIA, Nov. 19, 2021 (GLOBE NEWSWIRE) -- 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) Stage 2 (N) Expansion Actual / Actual / Stage Recruitment Target Target Actual / Status TargetPart A (1st line 17/17 19/19 74/741 COMPLETENSCLC)Part B (2nd line 23/23 13/13 - COMPLETENSCLC)Part C (2nd line 18/18 21/192 - COMPLETEHNSCC)

About the TACTI-002 Trial