Immutep Up as Combo Therapy Meets Carcinoma Study Goals

Immutep Limited IMMP jumped 14.9% after it announced positive results from cohort B of the late-stage TACTI-003 (KEYNOTE-PNC-34) study. The study evaluated the combination of its pipeline candidate eftilagimod alfa (efti) and Merck's MRK Keytruda (pembrolizumab) as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC) with negative PD-L1 expression.

Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist, which is being developed for cancer treatment. 

Per the data readout from cohort B of the phase III study, the investigational immuno-oncology combination achieved an objective response rate (ORR) of 35.5% and a disease control rate (DCR) of 58.1% in 1L HNSCC patients with negative PD-L1 expression, according to RECIST 1.1 criteria. Please note that the ORR was the primary endpoint of the study.

These results, obtained for a chemotherapy-free approach, are notably higher than the historical control of 5.4% ORR and 32.4% DCR for anti-PD-1 monotherapy. The combo regimen of efti and Merck's Keytruda also showed a high complete response rate of 9.7% compared with 0% in historical controls from anti-PD-1 monotherapy in the same patient population.

Year to date, shares of Immutep have lost 3.7% compared with the industry's 2.5% decline.

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Furthermore, Immutep also reported promising durability of responses upon treatment of 1L HNSCC patients with the combo therapy of efti and Merck's Keytruda. More than 50% of patients in cohort B have already been treated with combo therapy for at least six months, with three more nearing this duration. The combination also maintains a favorable safety profile, with no new safety concerns observed.

This new data strengthens the evidence that efti's novel mechanism of action significantly boosts the immune system, enhancing the effectiveness of immune checkpoint inhibitors like Keytruda. Per Immutep, efti is currently the only MHC Class II agonist in clinical development.

Based on such reassuring efficacy and safety data, the company is gearing up to discuss the path forward with regulatory agencies.

The company is also evaluating efti combination therapy for the second-line treatment of HNSCC in a separate mid-stage study.

Apart from HNSCC, Immutep is also evaluating efti in combination with other agents for the treatment of a variety of solid tumors, including non-small cell lung cancer and metastatic breast cancer.

Merck's Keytruda is currently marketed as the standard of care in the frontline treatment of metastatic non-small cell lung cancer patients. Keytruda, an anti-PD-1 therapy, is MRK's blockbuster oncology drug. It is approved for several types of cancer, accounting alone for 47% of the company's pharmaceutical sales in 2023.

Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck's position in the oncology market.

Zacks Rank and Stocks to Consider

Immutep currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industryare Arcutis Biotherapeutics ARQT and Annovis Bio ANVS, each carrying a Zacks Rank #2 (Buy) at present.

In the past 30 days, the Zacks Consensus Estimate for Arcutis Biotherapeutics' 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 228.8%.

Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.

In the past 30 days, the Zacks Consensus Estimate for Annovis' 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 35%.

ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.

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