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Frontier Medicines Presents Promising Anti-Tumor Activity from Phase 1/2 PROSPER Trial of FMC-376 in a Highly Resistant Patient Population of KRAS G12C-Mutant NSCLC at ESMO 2026

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  • FMC-376 is an equipotent ON+OFF KRAS G12C inhibitor designed with the Frontier™ Platform to address limitations of current KRAS G12C inhibitors, including resistance and tolerability

  • Treatment with FMC-376 in the Phase 1A portion of the trial led to confirmed overall objective response rate of 56% in NSCLC patients, including 67% in KRAS G12C inhibitor-naïve patients and 44% in patients previously treated with OFF-state KRAS G12C inhibitors, with 90% of responders harboring at least one co-alteration associated with clinical resistance to KRAS inhibitors

  • FMC-376 demonstrated 7.5 months median duration of response, with 60% of responders ongoing at time of data update

  • FMC-376 was well tolerated, with low rates of gastrointestinal toxicities and hepatic transaminase elevations, which are known class effects of other KRAS G12C inhibitors

  • Phase 1/2 PROSPER trial is ongoing in NSCLC, evaluating: 1) FMC-376 in combination with pembrolizumab, 2) FMC-376 monotherapy in a randomized dose-optimization cohort in patients naïve to or previously treated with OFF-state KRAS G12C inhibitors, and 3) FMC-376 as first-line monotherapy

BOSTON & SOUTH SAN FRANCISCO, Calif., October 25, 2026--Frontier Medicines Corporation, a clinical-stage precision medicines company unlocking the proteome to develop small molecule oncology and immunology drugs against previously undruggable disease-causing targets, today announced promising preliminary clinical data from the ongoing Phase 1 monotherapy portion of its Phase 1/2 PROSPER trial evaluating FMC-376, a KRAS G12C ON+OFF inhibitor, in patients with advanced KRAS G12C-mutant solid tumors, focused on non-small cell lung cancer (NSCLC). The findings were presented during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

"These first clinical data for FMC-376 mark an important step for Frontier, demonstrating encouraging responses and durability in a highly G12C-resistant population, as well as a favorable hepatic safety profile that we believe could be particularly important in combination with pembrolizumab in the first-line setting," said Chris Varma, Ph.D., co-founder, chairperson and chief executive officer of Frontier Medicines. "Designed to inhibit both the ON and OFF states of KRAS G12C with equal potency to address limitations of existing therapies, FMC-376 exemplifies the drug design capabilities of our AI-powered Frontier™ Platform and its potential to deliver differentiated precision medicines against targets long considered undruggable. Due to its equipotent ON and OFF activity, FMC-376 delivered best-in-class efficacy in a heavily pre-treated and highly resistant population, where 90% of responders harbored at least one co-alteration associated with clinical resistance to KRAS inhibitors. We look forward to continuing to advance the PROSPER study across cohorts, with the goal of bringing an impactful treatment option to patients in need."

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