On October 19, 2026 Quanta Therapeutics, a privately held, clinical-stage biopharmaceutical company leading the development of innovative therapeutics for RAS-driven cancers, reported that it will present clinical data for its oral, G12D-preferring multi-KRAS inhibitor QTX3034 in combination with cetuximab with or without FOLFOX chemotherapy in patients with CRC at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress taking place October 23-27 in Madrid, Spain. Quanta also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to QTX3034 for the treatment of KRASG12D-mutant CRC in combination with cetuximab, with or without FOLFOX chemotherapy, the same treatment regimens for which clinical data will be presented at ESMO (Free ESMO Whitepaper).
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"We look forward to presenting new clinical data at ESMO (Free ESMO Whitepaper) highlighting the potential of QTX3034-based combinations to improve outcomes for patients with KRASG12D-mutant CRC," said Perry Nisen, M.D., Ph.D., Chief Executive Officer of Quanta. "We are particularly pleased that these data supported the FDA’s decision to grant Fast Track designation for QTX3034 in this patient population. We believe this represents the first Fast Track designation based on clinical data for a KRAS G12D-targeted therapy in CRC, underscoring the significant unmet need in this population and the importance of advancing innovative treatment options for these patients."
ESMO presentation information:
Title: Preliminary clinical results of QTX3034, an oral G12D-preferring KRAS inhibitor, in combination with cetuximab ± mFOLFOX6 in patients with KRASG12D-mutated colorectal cancer (CRC)
Session Date and Time: Saturday, October 24, 2026; 2:45-4:15 pm CEST
Session Name: Rapid oral: Gastrointestinal tumours, lower digestive
Abstract Number: 790RO
About FDA Fast Track Designation
FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and non-clinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met. For more information on the Fast Track process, please visit the FDA’s official website.
(Press release, Quanta Therapeutics, OCT 19, 2026, View Source [SID1234673602])