Goed nieuws!
Immutep krijgt steun van de Amerikaanse FDA voor immunotherapiemedicijn
Australian biotech company, Immutep (IMM), has received approval from the United States Food and Drug Administration (FDA) to move ahead with its late-stage clinical plans for the treatment of first-line, non-small cell lung cancer (NSCLC).
The trial will assess the efficacy of eftilagimod alpha (Efti) in combination with an anti-PD-1 therapy, based on positive results from Immutep’s phase two TACTI-002, part A study.
The FDA’s approval was discussed during the 37th Annual Society of Immunotherapy of Cancer (SITC) meeting in November 2022, where both parties expressed interest in the trial.
The study, dubbed TACTI-004, will focus on first line NSCLC patients with a tumour proportion score (TPS) PD-L1 of less than one per cent, as Efti has already received fast track designation for low TPS scores.
Immutep CEO Marc Voigt said the meeting with the FDA was a critical step in the late-stage development process for NSCLC treatment.
“We are thankful for the positive feedback as we continue moving forward with our unique immuno-oncology approach for the many cancer patients impacted by this difficult disease,” Mr Voigt said.
Toxicological packages have also been discussed, as well as general aspects of the trial design, including statistics.
Efti is under evaluation for a variety of solid tumours including NSCLC, head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer.