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ASX / Media Release Immutep Quarterly Activities Report & Appendix 4C ● Received competent authority and institutional review board approvals for TACTI - 003 Phase IIb trial Enrolled first patient in INSIGHT - 003 study in patients with various solid tumours Preparations progressing for new Phase III trial ( AIPAC - 003 ) in metastatic breast cancer Final Overall Survival data from Phase IIb AIPAC trial accepted as a late breaker poster for SITC 2021 LAG - 3 IMMUNOTHERAPY SYDNEY , AUSTRALIA - 28 October 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 , provides an update on the ongoing development of its product candidates , eftilagimod alpha ( " efti " ) and IMP761 for the quarter ended 30 September 2021 . Efti Development Program for Cancer AIPAC - Phase IIb clinical trial - ongoing Immutep will report final Overall Survival ( OS ) data from its Phase IIb AIPAC clinical trial evaluating efti in metastatic breast cancer as a late breaker poster at the Society for Immunotherapy of Cancer ( SITC ) Annual Meeting 2021 taking place in the US and virtually from 10-14 November . Immutep previously reported initial OS data from approximately 60 % of events in December 2020 at the San Antonio Breast Cancer Symposium . The study reported a promising and improving trend in OS in the total population with a median survival benefit of +2.7 months from efti plus chemotherapy , compared to chemotherapy plus placebo . In addition , a statistically significant OS benefit was observed in the efti group in key pre - defined patient groups , including patients under 65 years of age and those with low starting monocyte count . AIPAC - 003 - Phase III - new Immutep is continuing the preparation and planning steps for its Phase III clinical trial evaluating efti in patients with metastatic breast cancer . TACTI - 003 - Phase IIb clinical trial - new In July 2021 , Immutep completed all the necessary competent authority steps with the US Food and Drug Administration ( FDA ) and has received institutional review board approval to commence its Phase Ilb TACTI - 003 trial in the US . Recruitment has also opened in the Ukraine and more sites and countries will be added in the coming months . This follows the receipt of Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma ( HNSCC ) from the US FDA in April 2021 . In addition , Immutep will be presenting the trial design for TACTI - 003 via a poster at the SITC 2021 conference in November . TACTI - 002 ( also designated KEYNOTE - PN798 ) - Phase II clinical trial - ongoing In September 2021 , Immutep enrolled the last patient into Stage 2 of Part B of the Phase II TACTI - 002 study , completing recruitment of 2nd line PD - 1 / PD - L1 refractory non - small cell lung cancer ( NSCLC ) patients into the trial . Recruitment is continuing for the additional 74 1st line NSCLC patients for the expansion of Part A , with 70 patients already enrolled . Recruitment for the expansion of Part A of the study continues to be ahead of the expected recruitment rate . Immutep Limited , Level 12 , 95 Pitt Street , Sydney NSW 2000 ABN : 90 009 237 889