Immutep (ASX:IMM), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, has announced that the requisite number of predefined patient responses has been exceeded in cohort 1 of Part A (first-line non-small cell lung cancer (NSCLC)) of the TACTI-002 Phase 2 clinical trial based on an interim analysis.
The company says this means it will proceed with the recruitment of an additional 19 patients for cohort 2 of Part A of the study.
The TACTI-002 study is being conducted in collaboration with US company MSD.
"The decision by the Data Monitoring Committee (DMC) to open cohort 2 follows the review of preliminary safety and efficacy data and their recommendation is based on predefined safety and efficacy thresholds," said the company in a statement.
"For seven out of 17 (41.2 %) a partial response (PR) according to RECIST 1.1 was observed as the best overall response (BOR) as of the data cut-off (September 6, 2019) in this interim analysis.
"An additional six patients had a stabilization of disease (SD) as best overall response at this point leading to a disease control rate of 76.5 % in this highly aggressive tumour entity.
"Twelve patients are currently continuing treatment. Patients were allowed to participate regardless of their PD-L1 status which is a well-known predictive marker for response to pembrolizumab in NSCLC."
Immutep said an additional 19 patients will be recruited to participate in Part A, bringing the total number of patients to 36, adding recruitment is ongoing for Parts B (second line non-small cell lung cancer) and C (second line head and neck squamous cell carcinoma (HNSCC) of the trial.
“We are pleased with the recruitment of patients in the TACTI-002 clinical trial to date. After dosing the first patient in March this year, we already have 32 patients on study," said Immutep CSO and CMO, Dr Frederic Triebel.
"In addition, we are encouraged by the early signals of efficacy seen in the more advanced part A of the study that appear to be consistent with the synergistic efficacy seen in combining efti with pembrolizumab in the TACTI-mel clinical trial. We very much look forward to presenting more detailed and more mature data at the 34th Annual Meeting of SITC in November.”