Intensity Therapeutics reports data from Invincible-4 study

Intensity Therapeutics (INTS) announces first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen as shown in Figure 1. The left panel shows an MRI scan of a patient in the INT230-6 cohort with a 2.4 cm tumor. After 2 doses given on day 1 and day 8, the follow-up scan in the right panel taken before the start of the immune/chemo regimen showed substantial necrosis with low levels of residual cancer seen only at the edges of the tumor. 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, i.e., the absence of live cancer in the primary tumor and affected lymph nodes. Patients are being randomized one-to-one to receive either a regimen of two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or SOC alone. The study is recruiting patients in Switzerland and France and is expected to enroll 54 patients.