Full Press Release Details
Immutep s Phase II TACTI-002 Study
Reports Encouraging Data at SITC
SYDNEY, AUSTRALIA 10 November 2020 Immutep Limited (ASX: IMM; NASDAQ:
IMMP) announces encouraging new interim data from its ongoing Phase II TACTI-002 study evaluating the combination of eftilagimod alpha ( efti or IMP321 ) with MSD s KEYTRUDA (pembrolizumab).
The data was presented by TACTI-002
Principal Investigator, Dr Matthew Krebs of the Christie NHS Foundation Trust in Manchester, UK at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting as part of a late breaker poster presentation and poster
walk for highly scored abstracts.
The poster is also available on Immutep s website: www.immutep.com
Principal investigator, Dr Matthew Krebs, said: In first-line NSCLC and second-line HNSCC we are seeing very encouraging results compared to
historical studies where pembrolizumab has been given as monotherapy in comparable patient groups. These results highlight the potential therapeutic benefit of adding efti to the checkpoint inhibitor pembrolizumab, together with an excellent safety
profile. The data strongly support further evaluation of the combination in both lung and head and neck cancers.
Immutep CSO and CMO, Dr
Frederic Triebel said: We are very encouraged by the number of lung cancer and head and neck cancer patients responding to efti in combination with pembrolizumab, including many patients that wouldn t typically respond to immune
checkpoint therapy. We have presented here more mature data from Stage 1 of Parts A and C of the trial, along with first data from Stage 2 of Parts A and C. We have also presented first data from Part B of the trial where patients are PD-1 resistant (confirmed by two confirmatory scans).
The results from this trial, and our other trials, continue to
support our hypothesis that the combination of our lead product candidiate, efti, with a PD-1 inhibtor such as pembrolizumab should result in a meaningful benefit to patients across various cancers. These
results are supportive of further late stage clinical development.
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Table 1 TACTI-002 Interim Results (data cut-off date: 8 October 2020)
| Part A 1st line NSCLC | Part B 2nd line NSCLC | Part C 2nd line HNSCC | ||||||||||
| Tumour response - iBOR per iRECIST | Stages 1 & 2 N (%) Total (N=36) | Stage 1 N (%) Total (N=23) | Stage 1 & 2 N (%) Total (N=28) | |||||||||
| Complete Response (iCR) | 2 (5.6) | 0 (0) | 3 (10.7) | |||||||||
| Partial Response (iPR) | 11 (30.6) | 1 (4.4) | 7 (25.0) | |||||||||
| Stable Disease (iSD) | 11 (30.6) | 7 (30.4) | 3 (10.7) | |||||||||
| Progressive Disease (iPD) | 9 (25.0) | 14 (60.9) | 10 (35.7) | |||||||||
| Not evaluable | 3 (8.3) | 1 (4.4) | 5 (17.9) | |||||||||
| Disease Control Rate (DCR) | 24 (66.7) | 8 (34.8) | 13 (46.4) | |||||||||
| Objective Response Rate (iORR) ITT* | 13 (36.1) | 1 (4.4) | 10 (35.7) | |||||||||
| Objective Response Rate in eval. pts | 13 (39.4) | 1 (4.5) | 10 (43.5) |
2nd line HNSCC - Part C
Stages 1 and 2 combined results commentary:
Conclusion: Data presented for HNSCC is very robust and form an excellent basis for late stage clinical development in this indication.
1st line NSCLC - Part A
Stages 1 and 2 combined results
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The patient characteristics of Stages 1 and 2 of Part A of TACTI-002
are shown in Table 2. The median age of patients in Stage 2 is almost 10 years older than patients in Stage 1. Furthermore, 84% of patients in Stage 2 had an ECOG status of 1 meaning that they are more impacted from deteriorating health, whereas
only 29.4% of patients from Stage 1 had an ECOG status of 1.
Table 2 TACTI-002 Part A (Stages 1 and
2) Patient Characteristics (excerpt)
| Baseline Characteristics | Stage 1 (N=17) N (%) | Stage 2 (N=19) N (%) | Stage 1+2 (N=36) N (%) | |||||||||
| Median age, years (range) | 65 (53-76) | 74 (60-84) | 68.5 (53-84) | |||||||||
| ECOG 0 | 12 (70.6) | 3 (16) | 15 (41.7) | |||||||||
| ECOG 1 | 5 (29.4) | 16 (84) | 21 (58.3) | |||||||||
| Squamous (SQ) | 10 (58.8) | 5 (26) | 15 (41.7) | |||||||||
| Non-squamous (NSQ) | 7 (41.2) | 14 (73) | 21 (58.3) |
The percentage of patients with progressive disease was similar in both stages (refer to Table 3 below) suggesting a similar
overall clinical benefit from the combination therapy in both sets of patients.
Notably, there were more patients in Stage 2 with radiological assessment
not reaching the arbitrary 30% bar that were then categorized as having stable disease rather than a partial response , possibly due to worse initial prognostic characteristics (i.e. older age and worse ECOG status) of those
Table 3 TACTI-002 Part A (Stages 1 and 2) Interim Results
| Tumour response (iRECIST) | Stage 1 (N=17) N (%) | Stage 2 (N=19) N (%) | Stage 1+2 (N=36) N (%) | |||||||||
| Complete Response | 1 (5.9) | 1 (5.3) | 2 (5.6) | |||||||||
| Partial Response | 8 (47.1) | 3 (15.8) | 11 (30.6) | |||||||||
| Stable Disease | 4 (23.5) | 7 (36.8) | 11 (30.6) | |||||||||
| Progressive Disease | 4 (23.5) | 5 (26.3) | 9 (25.0) | |||||||||
| Not Evaluable | 0 (0) | 3 (15.8) | 3 (8.3) | |||||||||
| Overall Response Rate ITT | 13 (36.1) | |||||||||||
| [95% Cl interval] | [20.8-53.8] | |||||||||||
| Overall Response Rate (evaluable patients only) | 13/33 (39.4) | |||||||||||
| Disease Control Rate | 24 (66.7) |
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Conclusion: Data presented for 1st line NSCLC are
favorable and form an excellent basis for further clinical development in this indication.
2nd line NSCLC - Part B
Stage 1 results commentary:
Conclusion: Data presented for 2nd line
PD-1/PD-L1 resistant NSCLC looks very encouraging especially if compared to alternative treatment options. Based on this data, the DMC confirmed a positive risk-benefit
ratio for Part B and recommended the opening of Stage 2 of this part.
The combination treatment continues to be safe and well tolerated with no new safety signals reported so far.
TACTI-002 Recruitment Update
Recruitment into the TACTI-002 trial continues to progress well and is ongoing for Stage 2 of Part C. Part B has
received a favorable DMC recommendation to open Stage 2 for recruitment. In total, 94 patients out of up to 109 are enrolled across 12 clinical sites in Australia, Europe, the UK and US.
Recruitment details for each part of the trial are shown in Table 4.
Table 4 TACTI-002 Recruitment (as at 2 November 2020)
| Stage 1 (N) Actual / target | Stage 2 (N) Actual / target | Recruitment Status | ||||
| Part A (1st line NSCLC) | 17/17 | 19/19 | COMPLETE | |||
| Part B (2nd line NSCLC) | 23/23 | 0/13 | NOT YET OPENED | |||
| Part C (2nd line HNSCC) | 18/18 | 17/19 | ONGOING |
expects to report more mature data from TACTI-002 in the first half of CY 2021.
About the TACT-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 efti with MSD s
KEYTRUDA (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second
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More information about the trial can be found on Immutep s website or on ClinicalTrials.gov (Identifier:
Immutep is a globally
active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its
technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
Immutep s current lead product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble
LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC)
activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products,
including antibodies for immune response modulation, are being developed by Immutep s large pharmaceutical partners.
Further information can be
found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 12, 95 Pitt Street, Sydney NSW 2000