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Immutep Reaches 50% Enrolment in Global Phase III Lung Cancer Trial

Story Highlights
  • Immutep has enrolled 378 patients, reaching 50% of target in its global TACTI-004 Phase III trial in first-line advanced or metastatic non-small cell lung cancer as of February 6, 2026.
  • The registrational study, now active at more than 140 sites in 27 countries, remains on schedule for a first-quarter 2026 futility analysis and full patient enrolment by the third quarter, underscoring growing clinical momentum for Immutep’s efti-based combination regimen.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Immutep Reaches 50% Enrolment in Global Phase III Lung Cancer Trial

Meet Samuel – Your Personal Investing Prophet

Immutep ( (IMMP) ) has provided an announcement.

On February 6, 2026, Immutep announced it had reached 50% of target enrolment in its global TACTI-004 (KEYNOTE-F91) Phase III trial in first-line advanced or metastatic non-small cell lung cancer, with 378 patients now enrolled worldwide. The trial evaluates eftilagimod alfa in combination with Merck’s KEYTRUDA and chemotherapy, aiming to improve outcomes across all PD-L1 expression levels in one of oncology’s largest and deadliest markets.

Management highlighted the rapid global enrolment pace, supported by more than 140 activated sites across 27 countries, as validation of high clinical interest in the efti combination. The company reiterated that a planned futility analysis remains on track for the first quarter of calendar 2026 and full enrolment is expected by the third quarter, marking a significant operational milestone in this registrational program that could materially influence Immutep’s competitive position and future commercial prospects in lung cancer if successful.

The TACTI-004 study will ultimately enrol approximately 756 patients with non-squamous or squamous tumours and no EGFR, ALK, or ROS1 aberrations, randomised to receive either efti plus pembrolizumab and chemotherapy or a pembrolizumab–chemotherapy–placebo regimen. With dual primary endpoints of progression-free and overall survival, the outcome of this trial will be central to determining whether the efti-based regimen can become a new standard of care in first-line NSCLC and support Immutep’s transition toward commercial-stage operations.

The most recent analyst rating on (IMMP) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Immutep stock, see the IMMP Stock Forecast page.

Spark’s Take on IMMP Stock

According to Spark, TipRanks’ AI Analyst, IMMP is a Neutral.

Score is held back primarily by weak financial performance (ongoing losses and negative cash flows). Technicals are a meaningful positive with a strong uptrend and positive MACD, but the overbought RSI raises near-term risk. Valuation is constrained by negative earnings and no dividend yield data.

To see Spark’s full report on IMMP stock, click here.

More about Immutep

Immutep Limited is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases. The company is a pioneer in therapeutics targeting Lymphocyte Activation Gene-3 (LAG-3), with a diversified product portfolio built around modulating the immune system, including its lead MHC Class II agonist eftilagimod alfa for multiple solid tumours such as non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer.

Immutep’s lead candidate efti is designed to activate antigen-presenting cells to drive both adaptive and innate anti-cancer immune responses, and is being combined with checkpoint inhibitors, chemotherapy, and radiotherapy across trials. The company’s strategy aims to establish efti-based combinations as new standards of care in major oncology indications while leveraging favourable safety data and regulatory designations to advance late-stage clinical development and create value for shareholders.

Average Trading Volume: 737,485

Technical Sentiment Signal: Buy

Current Market Cap: $381.2M

See more insights into IMMP stock on TipRanks’ Stock Analysis page.

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