Intensity and SAKK announce EMA authorization to begin with INVINCIBLE-4

Intensity Therapeutics (INTS) and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals, announced that the European Medicines Agency, or EMA, has authorized the initiation of the INVINCIBLE-4 in France in collaboration with Unicancer. The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer who undergo standard of care neoadjuvant immunochemotherapy, or SOC, treatment and SOC alone. The primary endpoint is pathological complete response, or pCR, in the primary tumor and affected lymph nodes. Patients will be randomized one-to-one to receive a regimen of either two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or the SOC alone. The study is already recruiting patients in Switzerland and is expected to enroll 54 patients.