AIPAC poster presentation includes new data and graphs showing:- Very encouraging Overall Survival (OS) data from the abstract published on
9 November 2021 , including statistically significant benefit in 3 patient subgroups representing a majority of patients - A statistically significant Quality of Life preservation in first 6 months in the eftilagimod alpha (“efti”) group in total population
- The statistically significant increase in peripheral CD8 T cells in patients in the efti group of the total population1 and the statistically significant correlation of this increase with improved OS
- Very encouraging Overall Survival (OS) data from the abstract published on
- TACTI-002 poster presentation of more mature interim data from 2nd line head and neck squamous cell carcinoma (HNSCC) patients (Part C):
- Encouraging Overall Response Rate (ORR), with 29.7% (11/37) of 2nd line HNSCC patients responding to the combination therapy of efti and pembrolizumab
- Favourable duration and depth of responses, with 5 Complete Responses and a minimum duration of response extended to > 9 months across all responding patients
- Responses continue to be seen in PD-L1 low and high expressors
- Further data from TACTI-002 is expected to be reported in H1 calendar year 2022
- TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled, trial enrolling approximately 154 patients with 1st line HNSCC
All three poster presentations relate to Immutep’s lead candidate efti and are available on the Company’s website: https://www.immutep.com/investors-media/presentations.html. New data which is shown in addition to the data from the abstracts released on
PHASE IIB
In addition to the final OS data announced on
Figure 1. Quality of Life at 3 and 6 months of treatment(Global Health Status / QoL QLQC30-B23)2
As previously announced, the
- Patients under the age of 65 years (representing 66.7% of patients in the efti group) reported a median OS of 22.3 months compared to 14.8 months in the comparator group, indicating an absolute survival benefit of +7.5 months (HR = 0.66; p = 0.017) favoring the efti group (see Figure 2).
- Patients with a low monocyte count (< 0.25/nl) at the commencement of the study (representing 21.9% of patients in the efti group) reported a median OS of 32.5 months compared to 12.9 months in the comparator group, indicating an absolute survival benefit of +19.6 months (HR = 0.44; p = 0.008) favoring the efti group.
- Patients with a more proliferating tumor cell type expressing more neo-antigens (i.e. leading to more immunogenicity), characterised as luminal B (representing 48.8% of patients in the efti group) reported a median OS of 16.8 months compared to 12.6 months in the comparator group, indicating an absolute survival benefit of +4.2 months (HR = 0.67; p = 0.049) favoring the efti group.
Figure 2. Kaplan-Meier curve for OS in patients <65 years of age
Table 1 – Overall Survival in key patient subgroups at final analysis at 72.5% of events in the overall population
Group | % of patients in efti group | Efti group / Comparator group | Median OS (months) | Absolute OS benefit from efti | |
Total Population | 100 | % | Efti + paclitaxel | 20.4 | +2.9 months HR = 0.88 p = 0.197 |
Placebo + paclitaxel | 17.5 | ||||
< 65 years old | 66.7 | % | Efti + paclitaxel | 22.3 | +7.5 months HR = 0.66 p = 0.017 |
Placebo + paclitaxel | 14.8 | ||||
Low monocytes < 0.25/nl | 21.9 | % | Efti + paclitaxel | 32.5 | +19.6 months HR = 0.44 p = 0.008 |
Placebo + paclitaxel | 12.9 | ||||
Luminal B | 48.8 | % | Efti + paclitaxel | 16.8 | +4.2 months HR = 0.67 p = 0.049 |
Placebo + paclitaxel | 12.6 |
Pleasingly, these results have improved since interim data were reported at the San Antonio Breast Cancer Symposium (SABCS) in
Table 2 – Comparison of interimOverall Survivaldata and final Overall Survivaldata
Group | Interim data (SABCS 20) | Final data (SITC 21) | Median OS improvement [months] |
Total Population | +2.7 months HR = 0.83 p = 0.14 | +2.9 months HR = 0.88 p = 0.197 | +0.2 |
< 65 years old | +7.1 months HR = 0.62 p = 0.012 | +7.5 months HR = 0.66 p = 0.017 | +0.4 |
Low monocytes < 0.25/nl | +9.4 months HR = 0.47 p = 0.02 | +19.6 months HR = 0.44 p = 0.008 | +10.2 |
Luminal B | +3.8 months HR = 0.69 p = 0.077 | +4.2 months HR = 0.67 p = 0.049 | +0.4 |
In addition, as briefly reported on
PHASE II TACTI-002 POSTER PRESENTATION
Immutep’s TACTI-002 is being conducted in collaboration with Merck & Co., Inc.,
Immutep CSO and CMO, Dr
Key Findings 2nd line HNSCC - Part C
- ORR of 29.7% (11/37) per iRECIST in patients unselected for PD-L1 on an intention-to-treat basis and 35.5% (11/31) in evaluable patients
- 13.5% of patients (5/37) reporting a Complete Response, indicating deep responses
- Median duration of response is not yet reached and none of the patients with a confirmed response progressed within 9 months
- 5 patients still under therapy and 1 patient completed 2 years of therapy
- ORR in patients in the PD-L1 ≥ 1 (N = 27) and PD-L1 ≥ 20 (N = 14) subgroups is 40.7% and 64.3%, respectively
Table 3– TACTI-002 Interim ORR Results for Part C (data cut-off date: 4 August 2021)
Part C 2nd line HNSCC3 | |
Tumour Response Best Overall Response (BOR) per iRECIST | Stage 1 & 2 N (%) Total N=37 |
Complete Response (CR) | 5 (13.5) |
Partial Response (PR) | 6 (16.2) |
Stable Disease (SD) | 3 (8.1) |
Progressive Disease (PD) | 17 (45.9) |
Not Evaluable | 6 (16.2) |
Disease Control Rate (DCR) | 14 (37.8) |
Objective Response Rate (ORR) | 11 (29.7) |
ORR in evaluable pts (N=31) | 11 (35.5) |
Conclusion: The more mature data from 2nd line HNSCC patients continues to be encouraging, including when compared to historical studies with checkpoint inhibitor monotherapy in comparable patient groups. These results are supportive of Immutep’s randomised Phase IIb TACTI-003 study in the 1st line HNSCC indication conducted in collaboration with MSD. The trial design for the new TACTI-003 study is outlined below.
Safety (data cut-off date
The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.
Next Results
Further data from TACTI-002 are planned to be reported in H1 of calendar year 2022.
PHASE II TACTI-003 POSTER PRESENTATION
TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled, trial enrolling approximately 154 patients with 1st line HNSCC.
Patients will be enrolled into two cohorts (see Figure 5):
- Cohort A (approximately 130 patients) will evaluate the safety and efficacy of efti in combination with MSD’s KEYTRUDA® (pembrolizumab), compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive tumours (CPS ≥ 1).
- Cohort B (up to 24 patients) is an experimental arm which will determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumours (CPS < 1).
Figure 5.TACTI-003 trial design
Pembrolizumab will be given at a dose of 400 mg via intravenous infusion on day 1 of each 6-week treatment cycle (maximum of 18 infusions). Efti will be subcutaneously injected at a dose of 30 mg every 2 weeks for the first 6 months (4 cycles) and thereafter at a dose of 30 mg every 3 weeks for up to 2 years in total.
The primary endpoint of the study is ORR according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS). The TACTI-003 study is open for patient recruitment in the US and
GLOBAL WEBCAST
Date & Time: 8.00 am AEDT (
Register: https://fnn.webex.com/fnn/onstage/g.php?MTID=ef12af93633b5d17a2e4e176fcac2f070
Questions: Investors are invited to submit questions in advance via immutep@citadelmagnus.com.
A replay of the webcast will also be available at www.immutep.com from the day after the event.
About
Active Immunotherapy Paclitaxel (AIPAC) is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb clinical trial in HER2-negative/HR positive metastatic breast cancer.
The study is evaluating the combination of efti with paclitaxel chemotherapy. 227 HER2-negative/HR positive metastatic breast cancer patients are randomised 1:1 to a chemo-immunotherapy arm (efti plus paclitaxel) or to a comparator arm (placebo plus paclitaxel). Patients receive weekly paclitaxel at days 1, 8 and 15, with either efti or placebo injected subcutaneously on days 2 and 16 of each 4-week cycle, repeated for 6 cycles. Thereafter, patients pass over to the maintenance phase with efti alone.
For more information regarding the
About TACTI-002
TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc.,
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
Patients participate in one of the following:
• Part A - first line non-small cell lung cancer (NSCLC), PD-X naive
• Part B - second line NSCLC, PD-X refractory
• Part C - second line head and neck squamous cell carcinoma (HNSCC), PD-X naive
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. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1, 1-19 and ≥ 20 (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall less responsive.
More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier:
NCT03625323).
KEYTRUDA® is a registered trademark of
About TACTI-003
TACTI-003 is a Phase IIb clinical trial in first line head and neck squamous cell carcinoma (HNSCC) in collaboration with Merck & Co., Inc.,
The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in first line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ≥ 1) tumours (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumours (CPS < 1) (cohort B). According to the current plans, about 130 patients in cohort A will be randomised 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.
The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS).
About
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.
Further information can be found on the Company’s website www.immutep.com or by contacting:
+61 (0)406 759 268; cstrong@citadelmagnus.com
+1 (212) 915.2564; tim@lifesciadvisors.com
1 Immune monitoring was conducted on a selection of patients from the total population: N=36/31 comparator group/efti group.
2 * Differences are statistically significant.
3 As assessed by local investigator read.
Source:
2021 GlobeNewswire, Inc., source