Cue Biopharma presents updated data from Phase 1 trial of CUE-101

Cue Biopharma announced updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101. The data will be presented in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting today June 4, 2024, in Chicago, IL. Key data highlights to date from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose of 4mg/kg in combination with pembrolizumab with 24 evaluable 1L patients: ORR of 46% and Disease Control Rate of 79% in patients with combined positive score greater than or equal to1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response and 10 partial responses, in addition to eight durable stable diseases of greater than12 weeks. 12-month overall survival of 96%. Median progression free survival of 5.8 months compared to 3.2 months with pembrolizumab alone in the third-party KEYNOTE-048 trial. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 evaluable 2L+ patients: mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively. No unanticipated, significant safety concerns have emerged in either the combination or monotherapy trials, and adverse events have been readily managed with appropriate medical care. Key data highlights to date from the fully enrolled CUE-102 dose escalation part of the Phase 1 clinical trial include: DCR of 43.5%; Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reductions in tumor burden. Selective expansion of WT1-specific T cells in multiple patients. No dose-limiting toxicities or drug-related serious adverse events have been reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102. Expansion at CUE-102 4mg/kg is ongoing.