EFTILAGIMOD ALPHA


Associated tags: ASX, Cancer, Patient, Autoimmune disease, Pharmaceutical industry, IMM, MHC, PD-L1, Lung cancer, Pembrolizumab, NSCLC, Safety, Survival

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

Retrieved on: 
Wednesday, April 24, 2024
CPS, Cancer, DCR, HNSCC, Data collection, QOL, Neck, Pembrolizumab, Merck & Co., CQD, ASX, Fast track (FDA), PD-L1, Data, Autoimmune disease, Incidence, Patient, Head, Death, Quality of life, Merck, Neoplasm, IMM, Medical imaging

SYDNEY, AUSTRALIA, April 24, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.

Key Points: 
  • Head and neck squamous cell carcinomas are a heterogenous disease that represent a high unmet medical need regardless of PD-L1 expression.
  • A total of 33 patients with recurrent or metastatic HNSCC have been enrolled into Cohort B.
  • The final number of evaluable patients in Cohort B is expected to be higher and additional data, including complete response rate, will be released together with Cohort A data.
  • Patients in Cohort A are stratified by CPS >1, CPS 1-19, and CPS >20, and the clinical results for these three CPS groups will be evaluated.

Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, April 17, 2024
Medication, Cancer, Competence, Statistics, Regulation, CHMP, ASX, Autoimmune disease, Competent authority, AEMPS, NSCLC, IMM, Pharmaceutical industry

SYDNEY, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).

Key Points: 
  • SYDNEY, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
  • Immutep SVP, Regulatory & Strategy, Christian Mueller commented: “We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS.
  • Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and statistics, and the specificities of the patient population.
  • Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.

Immutep Announces First Clinical Data from 90mg Dosing of Efti

Retrieved on: 
Tuesday, March 5, 2024
MBC, Autoimmune disease, Safety, ASX, Observation, Paclitaxel, Patient, Disease, IMM, Cancer, Pharmaceutical industry

Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events.

Key Points: 
  • Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events.
  • Additionally, all treatment-emergent adverse events during the safety observation period to date have been of mild severity.
  • The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.
  • The ongoing randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing.

First Patient Dosed in Trial Evaluating Efti and the Anti-PD-L1 Therapy BAVENCIO® in Metastatic Urothelial Cancer

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Thursday, January 4, 2024
IO, Merck Group, ASX, Autoimmune disease, Immune system, Death, Bladder cancer, Carcinoma, Hope, IMM, PD-L1, Avelumab, Research, Cancer, Transitional cell carcinoma, Patient, Safety, Transitional epithelium

SYDNEY, AUSTRALIA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Key Points: 
  • The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.
  • Encouragingly, responses were achieved even in cancer patients with low and negative PD-L1 expression, who typically would not be expected to respond to anti-PD-(L)1 therapy.
  • Daniel Pink, as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.
  • For 2023, it was estimated there would be 82,290 new cases of bladder cancer and 16,710 deaths in the US alone.1

Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, December 21, 2023
Lung cancer, ASX, Autoimmune disease, Food, PEI, FDA, Paul Ehrlich Institute, IMM, Cancer, Committee, Safety, NSCLC, PD-L1, CHMP, Pharmaceutical industry

SYDNEY, AUSTRALIA, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy.
  • Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.
  • Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.
  • Immutep CEO, Marc Voigt, commented: “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months.

Immutep Completes Enrollment in TACTI-003 Phase IIb Trial of Efti and KEYTRUDA® in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Thursday, November 9, 2023
ASX, MHC, Neoplasm, Patient, PD-L1, Pembrolizumab, Head, HNSCC, CPS, Phase, MHC class II, Autoimmune disease, Safety, IMM, Cancer, Cohort study, Pharmaceutical industry, Cohort

SYDNEY, AUSTRALIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the completion of patient enrollment in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti), its proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Key Points: 
  • Dr. Frédéric Triebel, CSO of Immutep, said: “The completion of patient enrollment in TACTI-003 represents an important milestone in the clinical development of efti.
  • We hope to build upon the encouraging data previously seen combining efti with the anti-PD-1 KEYTRUDA® in the second line HNSCC setting.
  • Head and neck squamous cell carcinomas represent a difficult-to-treat, heterogenous cancer and an area of high unmet need.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

Retrieved on: 
Monday, November 6, 2023
ASX, MHC, IDMC, Data monitoring committee, Optimus, Paclitaxel, Autoimmune disease, Safety, IMM, Cancer, Patient, Toxicity, Pharmaceutical industry

SYDNEY, AUSTRALIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues.

Key Points: 
  • The IDMC recommended proceeding to the randomised Phase II portion of the trial.
  • The randomised (1:1) Phase II portion of the study will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose.
  • Importantly the determination of the optimal biological dose is relevant for the whole efti program across all disease indications.
  • The integrated Phase II/III AIPAC-003 trial is evaluating efti, Immutep’s soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic hormone receptor positive (HR+), HER2-negative or HER2-low breast cancer and triple-negative breast cancer.

Immutep Announces New Biomarker Data from TACTI-002 Phase II in First Line Non-Small Cell Lung Cancer

Retrieved on: 
Friday, November 3, 2023
ASX, MHC, PD-L1, NSCLC, Gamma ray, Poster, ESMO, Progression-free survival, Biomarker, TPS, RNA, Society for Immunotherapy of Cancer, Pembrolizumab, GEP, AIPAC, Merck, CD8, SITC, T cell, Immunotherapy, Paclitaxel, Immune system, Annual general meeting, ALC, Blood, Autoimmune disease, Serum, Gene, Lung cancer, CXCL10, Lymphocyte, IMM, Cancer, Society, Monocyte, Patient, Merck & Co., Vaccine, Medical imaging, Pharmaceutical industry, LAG-3

SYDNEY, AUSTRALIA, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces new biomarker data from the TACTI-002/KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist administered subcutaneously, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • Dr Frederic Triebel, Immutep CSO, said, “Immunomonitoring of blood cells is of prime importance when one would like to understand the effect of a systemic immunostimulant injected subcutaneously, like efti is.
  • Importantly, the pharmacodynamic data from efti in combination with pembrolizumab is associated with the 35.5-month median Overall Survival in first-line treatment of metastastic non-small cell lung cancer patients expressing PD-L1 (TPS >1%) that we recently reported at ESMO 2023.
  • This biomarker data from the TACTI-002 Phase II is similar to the biomarker analysis from Immutep’s randomized, double-blind AIPAC Phase IIb trial in HER2-/HR+ metastatic breast cancer, which combined efti solely with paclitaxel chemotherapy and did not include any anti-PD-1 therapy.
  • The poster titled “Biomarker results from the 1st line non-small cell lung cancer cohort of TACTI-002: pharmacodynamic effects of combining eftilagimod alpha (soluble LAG-3) and pembrolizumab” will be available on the Posters & Publications section of Immutep’s website.

Immutep Reports Promising Clinical Data from INSIGHT-003 Trial at ESMO Congress 2023

Retrieved on: 
Tuesday, October 24, 2023
Patient, Progression-free survival, PFS, Palladium

SYDNEY, AUSTRALIA, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today provides an overview of the promising clinical data from the investigator-initiated INSIGHT-003 trial. The study evaluates a triple combination of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, with anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin/pemetrexed) as front-line therapy for metastatic or advanced non-squamous non-small cell lung cancer (NSCLC).

Key Points: 
  • We are building deeper insights into how efti jumpstarts the immune system to fight cancer through activation of dendritic cells, and its synergy with anti-PD-1 therapy.
  • The clinical data1 included a positive median Overall Survival (OS) that was not reached and encouraging median Progression Free Survival (PFS) of 10.1 months.
  • Immutep CSO, Dr. Frédéric Triebel, said: “Immutep continues to prioritise non-small cell lung cancer, one of the largest cancer indications globally, as the most significant area of focus in our late-stage development pipeline.
  • The compelling data that our proprietary MHC Class II agonist has generated in combination with immune checkpoint inhibitors for NSCLC patients positions efti as one of the more promising clinical candidates in immuno-oncology today.

Immutep’s Efti in Combination with KEYTRUDA® Generates Excellent Overall Survival Benefit in Patients with Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Monday, October 23, 2023
ASX, MHC, Progression-free survival, PD-L1, NSCLC, Mini, ESMO, Symantec Endpoint Protection, TPS, DOR, MOS, Pembrolizumab, PFS, Merck, Duration, Rated R, Survival, Autoimmune disease, ORR, ICO, IMM, Cancer, Patient, Merck & Co., Network equipment provider, Pharmaceutical industry

SYDNEY, AUSTRALIA, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • A significant overall survival benefit was achieved, with a 35.5-month median Overall Survival (mOS) in patients with TPS ≥1%, 23.4-month mOS in TPS 1-49%, and mOS not yet reached in TPS ≥50%.
  • Exceptional durability and quality of responses are increasingly evident with strong overall survival (OS) and progression free survival (PFS) rates across patients expressing PD-L1.
  • The 12-month PFS rates are 46.8%, 42.1%, and 55.0% for TPS >1%, TPS 1-49%, and TPS >50%, respectively.
  • Table 1: Overall Survival of Efti + KEYTRUDA® versus standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo