Immutep Completes Recruitment for Stage 1 of Part B in TACTI-002 Study

Rhea-AI Summary

Immutep has successfully enrolled 23 patients for Stage 1, Part B of its TACTI-002 Phase II study, focusing on second-line Non-Small Cell Lung Cancer (NSCLC). With 87 out of a target of 109 patients (80%) enrolled, recruitment for Stage 2 of Part C continues. The trial, partnered with Merck & Co., evaluates the combination of Immutep's eftilagimod alpha with KEYTRUDA in patients with head and neck squamous cell carcinoma and NSCLC. Further safety and efficacy data will be reviewed by a Data Monitoring Committee before proceeding with additional recruitment.

Positive

• Successful enrollment of 23 patients for Stage 1, Part B, completing recruitment for this phase.
• Overall recruitment is at 80% with 87 out of 109 patients enrolled.

Negative

• None.

• 23 patients with second line Non-Small Cell Lung Cancer (NSCLC) participating in Stage 1, Part B
  
• Total of 87 patients out of up to 109 patients (80%) are enrolled and participating in the trial, with recruitment continuing for stage 2 of Part C at present
• Further data from TACTI-002 expected throughout calendar year 2020

SYDNEY, Australia, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 1 of Part B of its TACTI-002 Phase II study, completing recruitment of stage 1 of Part B.

Based on the study’s Simon’s two-stage clinical trial design, safety and efficacy data will be provided to the Data Monitoring Committee (DMC) for its review and recommendation regarding opening recruitment into stage 2 of Part B once all patients have undergone at least one tumour imaging after treatment.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) and is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA^® (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or NSCLC in first and second line.

TACTI-002 Recruitment
Recruitment details for each Part of TACTI-002 are below. At present, recruitment is ongoing for Stage 2 of Part C. Pending the DMC’s recommendation, Immutep will consider opening stage 2 of Part B for recruitment.

	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	-/13	TBA
Part C (2nd line HNSCC)	18/18	10/19	ONGOING

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 line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe and Australia.

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. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ≥1% (US) and ≥50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).

About Immutep

Further information can be found on the Company’s website www.immutep.com or by contacting:

Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com

U.S. Media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com

FAQ

What are the results of Immutep's TACTI-002 Phase II study for NSCLC?

Immutep has completed recruitment for Stage 1, Part B of the TACTI-002 study, which enrolled 23 patients with NSCLC.

How many patients are enrolled in the TACTI-002 trial?

Currently, 87 patients are enrolled in the TACTI-002 trial, which is 80% of the target enrollment of 109.

What is the collaboration in TACTI-002 trial?

The TACTI-002 trial is conducted in collaboration with Merck & Co., and evaluates the combination of Immutep’s eftilagimod alpha with KEYTRUDA.

What is the next step for the TACTI-002 trial?

Further safety and efficacy data will be reviewed by the Data Monitoring Committee to decide on additional recruitment for Stage 2 of Part B.

What types of cancer are being studied in TACTI-002?

The TACTI-002 study focuses on second-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma.