Media Release
- Excellent survival benefit in 1st line non-small cell lung cancer (1L NSCLC) in TACTI-002 trial: median Overall Survival of 35.5 months (TPS ≥1% patients) providing additional 12-18 months survival compared to historical data, reported post period
- Late-stage & registrational trial progress:
- 1st line head & neck squamous cell carcinoma (1L HNSCC) - Phase IIb TACTI-003 trial recruitment progressing and expected to be complete in
November 2023 - 1L NSCLC - Preparations ongoing to commence Phase III TACTI-004 registrational trial in CY2024
- Metastatic breast cancer (MBC) - Patient recruitment ongoing for Phase II/III AIPAC-003 trial, first safety data from the open-label safety lead-in portion expected to be reported in Q4 CY2023
- 1st line head & neck squamous cell carcinoma (1L HNSCC) - Phase IIb TACTI-003 trial recruitment progressing and expected to be complete in
- Strong Overall Response Rate in INSIGHT-003 of 71.4%, plus encouraging response rate of 70.6% for low or negative PD-L1 expressors in NSCLC comparing favourably to historical data, reported post period
- Efti trial expansion: First patient enrolled in EFTISARC-NEO Phase II trial in soft tissue sarcoma
- Well financed: Strong cash position of
$110.1m , with cash runway to early CY2026
EFTI DEVELOPMENT PROGRAM FOR CANCER
In
The Company also received regulatory authorisation in
TACTI-002 (KEYNOTE-PN798)
Phase II clinical trial evaluating efti + KEYTRUDA® (pembrolizumab)
1st line Non-Small Cell
Following the end of the quarter,
Exceeding expectations, median Overall Survival has reached 35.5 months in NSCLC patients expressing PD-L1 (patients with a Tumour Proportion Score (TPS) of ≥1%), 23.4 months in patients with low PD-L1 expression (TPS 1-49%) and encouragingly, has not yet been reached in patients with high PD-L1 expression (TPS ≥50%).
A 35.5-month survival benefit gives these patients 12 to 18 months of additional survival compared to historical data from the current best approved option: pembrolizumab in combination with doublet chemotherapy (see Table 1). In addition to the substantial survival benefit, the combination of efti and pembrolizumab is chemo-free, avoiding the toxic side effects seen in chemo options. Efti is enabling deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile in line with anti-PD-1 monotherapy.
Table 1: Overall Survival of Efti + KEYTRUDA® versus standard-of-care Immuno-Oncology (IO), IO-IO, IO-chemo, and IO-IO-chemo therapies for 1st line treatment of advanced non-small cell lung cancer patients with PD-L1 TPS ≥1%
Therapy | Median Overall Survival1 |
Efti + Pembrolizumab | 35.5 months |
Pembro + Doublet Chemo (NSQ)* | 23.3 months |
Pembro + Doublet Chemo (SQ)* | 18.9 months |
Ipilimumab + Nivolumab2 | 17.1 months |
Pembrolizumab monotherapy2 | 16.4 months |
Ipi + Nivo + 2 cycles Doublet Chemo | 15.8 months |
* NSQ = Non-squamous; SQ = Squamous
TACTI-003 – Phase IIb clinical trial in 1st line HNSCC
The Phase IIb TACTI-003 trial is ongoing in patients with 1st line HNSCC. Patient recruitment reached ~99% in October and is expected to be complete in
TACTI-004 – Phase III registrational trial in 1st line NSCLC
Throughout the quarter,
Patient recruitment into the
INSIGHT-003 – Phase I in 1st line NSCLC
At the
A strong Overall Response Rate of 71.4% and 90.5% Disease Control Rate were reported. Median Overall Survival (OS) has not yet been reached. The median Progression Free Survival (PFS) was 10.1 months.
In this study, 81% of patients have low or negative PD-L1 expression, making them typically less responsive to anti-PD-1 based therapy. For low or negative PD-L1 expressors (TPS <50%), the ORR was 70.6% which compares favourably to reported results from a registrational trial of anti-PD-1 and doublet chemotherapy that yielded a response rate of 40.8% in the same patient population.
INSIGHT-005 – Phase I trial in Urothelial Carcinoma
Following receipt of regulatory approvals to initiate INSIGHT-005, preparations to commence this investigator-initiated trial are continuing at the
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
The first soft tissue sarcoma (STS) patient was enrolled and safely dosed in the Phase II EFTISARC-NEO trial in July. The trial is the first chemo-free triple combination therapy of efti and is the first to evaluate it in a neoadjuvant setting. STS is an orphan disease with high unmet medical need and poor patient prognosis. Currently six patients have been recruited into this trial which is funded by a Polish grant program.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
During the quarter,
INTELLECTUAL PROPERTY
The Company was also granted a new patent by the Brazilian Industrial Property Office in September protecting Immutep’s potency assay for release testing of efti. This assay is used in the commercial-scale (2,000L) manufacturing process for efti. The Brazilian patent follows similar patents granted in
FINANCIAL SUMMARY
With a cash and cash equivalent balance as at
The Company has sufficient capital to reach key milestones that will potentially add value to efti and IMP761.
Cash receipts from customers in Q1 FY24 were
Payments of
The net cash used in R&D activities in the quarter was
Total net cash outflows used in operating activities in the quarter was
Payment for the acquisition of Intellectual Property was
About
+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S. Investors/Media:
+1 (631) 318 4000; chris.basta@immutep.com
1 Arrow lengths in Table 1 are proportional representations of OS data. Data for standard-of-care therapies taken from publications of respective registrational trials (e.g., KN-042, KN-189, KN-407, CM-227, CM-9LA), and comparison of data is from different clinical trials.
2 Ipi + Nivo approved in US for 1L NSCLC PD-L1 TPS >1% but not in EU; Pembro monotherapy not approved in
Source:
2023 GlobeNewswire, Inc., source