Immutep Ltd (ASX: IMM) shares are ending the week with a bang.
In morning trade, the ASX healthcare stock is up 25% to 37 cents.
Why is this ASX healthcare stock rocketing?
This clinical-stage biotechnology company's shares are taking off this morning after it announced positive results from Cohort B of the TACTI-003 Phase IIb trial.
This trial is evaluating eftilagimod alfa (efti) in combination with Merck & Co's anti-PD-1 therapy Keytruda (pembrolizumab) as a first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.
The release notes that the updated efficacy and safety data was presented by Dr. Robert Metcalf from the Christie NHS Foundation Trust during an oral presentation at the ESMO Virtual Plenary session on Thursday.
Dr Metcalf revealed that the investigational immuno-oncology (IO) combination utilising efti and Keytruda achieved an objective response rate (ORR) of 35.5% (11 of 31 evaluable patients). He also reported a disease control rate (DCR) of 58.1%, according to RECIST 1.1, in 1L HNSCC patients whose tumours do not express PD-L1 (Combined Positive Score [CPS] <1).
Is this good?
The above may read like gobbledygook if you're not familiar with clinical trials. But in summary, these are very positive and promising results.
In fact, the company notes that these results are "among the highest recorded for a chemotherapy-free approach in negative PD-L1 patients and compare favourably to a historical control of 5.4% ORR and 32.4% DCR from anti-PD-1 monotherapy."
Commenting on the trial results, Dr Metcalf said:
The high response rate from this novel immunotherapy combination is well above other treatment approaches without chemotherapy. It matches historical response rates from chemotherapy-based treatments but without the associated toxicities. This is really significant for patients with head and neck squamous cell carcinomas who have a CPS less than one and for whom chemotherapy is the current first line treatment.
Achieving complete responses in this group bodes well for this immunotherapy combination's future potential, especially given the positive trend in response durability. The clinically meaningful response rate and high unmet medical need warrant further investigation of eftilagimod plus pembrolizumab in this patient population.
In light of this data and the high unmet medical need, Immutep advised that it will discuss the path forward with regulatory agencies. And as Efti has previously received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression, these are promising times for the company. Though, there is still a long road ahead.
