In 2020, Intensity completed the Phase 1 portion of its Phase 1/2 study of INT230-6. The investigational drug is now being studied for multiple cancer types in Phase 2 cohorts.
Preliminary safety and response data from 53 subjects with different solid tumors who received monotherapy (INT230-6 alone), and 7 subjects who received INT230-6 combined with Keytruda® (pembrolizumab) in the phase 1 portion of our trial were reported at the Society for Immunotherapy of Cancer 2020 annual meeting. Several highly refractory patients have had disease stabilization for more than 6 months.
INT230-6 dosing is determined based on tumor size. A minimum threshold of dose per volume needed to saturate tumors as seen in nonclinical models appears to be relevant in humans. Analysis of dose response relationship is ongoing; however, results show that receiving INT230-6 doses equivalent to half of the tumor burden (for tumors above 2 cm in diameter) results in an increase in survival. Data presented show doses >50% compared to <50 provide a survival with a Hazard Ratio of 0.272 (95% CI: 0.125, 0.592) (p=0.00103).
Following treatment, many subjects’ tumors increase in size over baseline, then regress on subsequent scans (potential pseudo progression). Several patients showed some size reduction of one or more non injected lesions in lymph nodes, liver, lung, perineum, and retroperitoneal areas (abscopal effects to visceral lesions). The drug was well tolerated, with most adverse events being of low grade (1 or 2).