Quanta Therapeutics reports positive KRAS G12D combo data at ESMO
Quanta Therapeutics has presented Phase 1 clinical data at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid showing that its oral KRAS G12D inhibitor QTX3034, when combined with the anti-EGFR antibody cetuximab, produced a 75% disease control rate and a 25% overall response rate in patients with refractory colorectal cancer. The privately held, clinical-stage biopharmaceutical company described the results as clinical proof-of-concept for a combination strategy in a tumour type that has historically lacked effective targeted options.
The data, presented during a rapid oral session on 24 October, covered two combination arms with an August 2026 cut-off date. In the cetuximab cohort (n=21), QTX3034 at 1,200 mg twice daily produced five partial responses, two of them unconfirmed, with a median response duration of up to 5.5 months. Adding FOLFOX chemotherapy to the doublet in a primarily chemo-refractory population (n=11) lifted the overall response rate to 50% and the disease control rate to 90%, including one complete response in a chemotherapy-naive patient. Molecular response data were similarly encouraging: most patients across both regimens achieved greater than 90% clearance of G12D circulating tumour DNA.
Tolerability appeared broadly consistent with the known profile of cetuximab, with low rates of dose modification or discontinuation. QTX3034 plus FOLFOX added no new safety signals at either dose level tested.
Combination rationale and pipeline context
Ignacio Garrido-Laguna, principal investigator at Moffitt Cancer Center, said existing treatment options for metastatic colorectal cancer "frequently fall short due to resistance mechanisms," and described the combination data as evidence that direct KRAS blockade paired with EGFR-targeted therapy could improve disease control. Perry Nisen, Quanta's chief executive, said the findings support evaluation in earlier lines of therapy, where the tolerability profile would be an important consideration for regulators and clinicians alike.
The ESMO presentation coincided with Quanta announcing progress on its second pipeline asset, QTX6255, a pan-KRAS inhibitor designed to cover the broader range of KRAS mutations beyond G12D. The company said QTX6255 has a novel molecular scaffold producing what it describes as unprecedented oral bioavailability and is on track for an IND filing in the fourth quarter of 2026, with a Phase 1 trial anticipated to start in early 2027. A recently completed extension to the company's Series D financing provides runway through the key data readouts for this programme, though Quanta did not disclose the size of the extension or the resulting cash position.
Market and competitive landscape
KRAS has historically been regarded as undruggable, but the approval of sotorasib and adagrasib as G12C-selective inhibitors opened a new chapter in RAS-directed oncology. The more common G12D mutation, present in a significant proportion of colorectal and pancreatic cancers, has proved harder to target selectively, and no G12D-specific therapy is yet approved. A number of companies, including large-cap players and well-funded biotechs, are advancing G12D or pan-KRAS programmes through early clinical development, making the combination strategy Quanta is pursuing a differentiated approach worth watching. The company's SHG-based allosteric modulator platform is distinct from the covalent chemistries used in first-generation KRAS inhibitors, though clinical differentiation relative to competitors will ultimately depend on head-to-head data that do not yet exist.
With an IND for QTX6255 imminent and QTX3034 combination data now in the public domain, Quanta is positioning itself for a busy clinical period through 2027. Whether early-line combination studies in CRC will follow, and how quickly pan-KRAS data will emerge, are the near-term questions that will determine the programme's trajectory.