A New Generation of Cancer & Autoimmune Disease Treatment

Immunotherapy Clinical Trials.


AIPAC (ACTIVE IMMUNOTHERAPY PACLITAXEL)

Active Immunotherapy PAClitaxel (AIPAC) is Immutep’s most advanced and largest clinical trial. It is a Phase IIb clinical trial evaluating eftilagimod alpha (known as efti or IMP321) in combination with a taxane-based chemotherapy called paclitaxel in patients with hormone receptor positive metastatic breast cancer (MBC) as an immunotherapy. This combination treatment aims to boost the immune response against tumour cells compared to the chemotherapy treatment alone.

The study is taking place in Europe and consists of two parts: a safety run-in phase with 15 patients, which has now been completed, and a randomised and controlled phase which has fully recruited 227 patients.

Patients within the randomised and controlled phase of the study are placed into two different treatment groups: group A receives paclitaxel chemotherapy in combination with a placebo, while treatment group B receives paclitaxel chemotherapy in combination with efti. Thereafter, patients pass over to the maintenance phase.

AIPAC is a potentially pivotal trial, meaning subject to sufficient and clinically meaningful data and regulatory interactions, the final read-out of progression-free survival (PFS) data could serve as a basis to pursue regulatory approval pathways for efti with the European Medicines Agency and the U.S. Food and Drug Administration.

AIPAC (Active Immunotherapy PAClitaxel)

 

For further information about the study, please visit:

TACTI-002 (Two ACTive Immunotherapies)

Two ACTive Immunotherapies-002 (TACTI-002) 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® (or pembrolizumab, an anti-PD-1 therapy) for up to 109 patients.

The trial is a Phase II, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

TACTI-002 evaluates the combination therapy in three types of patients:

  1. First line Non-Small Cell Lung Cancer (NSCLC) – known as Part A
  2. Second line NSCLC PD-X refractory – known as Part B
  3. Second line Head and Neck Squamous Cell Carcinoma – known as Part C

The study has an adaptive trial design called Simon’s two-stage. This allows the number of patients in each Part to be increased if a predefined number of positive results are observed in stage 1, creating a stage 2. Recruitment is ongoing.

For further information about the study, please visit:

TACTI-MEL (TWO ACTIVE IMMUNOTHERAPEUTICS IN MELANOMA)

Two ACTive Immunotherapeutics in melanoma (TACTI-mel) is a Phase I safety and dose finding clinical trial of efti given in combination with pembrolizumab (Keytruda) in patients with locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma. The study combined two immunotherapies to enhance the immune response by activated T cells.

Patients having a suboptimal response or having had disease progression with pembrolizumab as a monotherapy were eligible for the study and received the combination of pembrolizumab plus efti.

TACTI-mel is taking place in Australia and involves four cohorts of six patients, bringing the total number of patients in the trial to 24. The first three cohorts received ascending subcutaneous doses of efti up to 30 mg per injection in combination with pembrolizumab. The fourth cohort of six patients received 30 mg of efti in combination with pembrolizumab, starting at cycle one of pembrolizumab. All patients were treated for up to 12 months.

Safety data so far demonstrates that efti has a very favorable safety profile. Final safety data will be reported soon.

Final efficacy data from TACTI-mel shows that patients are responding well to the combination treatment. Patients had an encouraging Overall Response Rates of 33% in Part A (where patients were dosed with efti at cycle 5 of prembrolizumab treatment) and 50% in Part B (where patients were dosed with efti from day 1 of cycle 1 of pembrolizumab).

This confirms deep and durable responses to the combination treatment, meaning that patient tumours are shrinking and not growing back over a long follow up period. In addition, the study reported the complete disappearance of all target tumour lesions for a number of patients and one complete confirmed response where the tumour has completely disappeared.

TACTI-mel (Two ACTive Immunotherapeutics in melanoma)

For further information about the study, please see:

INSIGHT-004

INSIGHT-004 is the 4th arm of the INSIGHT Phase I clinical trial. It is being conducted under Immutep’s new clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

The trial evaluates the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with advanced solid malignancies. It will assess the safety, tolerability and recommended Phase II dose of efti when combined with avelumab.

The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (IKF) is the sponsor of the clinical trial and it will be conducted under the existing protocol of IKF’s ongoing INSIGHT Phase I study.

Trial recruitment is ongoing and Immutep expects to report the first safety data soon.

For further information about the study, please see: