With the 2026 American Society of Clinical Oncology (ASCO) conference, held in Chicago from 29 May to 2 June, in full swing, there has been a notable buzz around readouts in hard-to-treat gastrointestinal (GI) indications such as pancreatic cancer.
One of the readouts that sent ripples through the space was that of the RASolute-302 trial on Revolution Medicines’ KRAS inhibitor, daraxonrasib, which was selected as one of the five plenary abstracts to be presented at the conference after the drug nearly doubled overall survival (OS) in patients with KRAS-mutated, metastatic pancreatic ductal adenocarcinoma (PDAC). Following this unprecedented win, analysts are touting daraxonrasib as a potentially landscape-changing drug.
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While daraxonrasib’s strong data is on everybody’s lips at ASCO, there have been several other key developments in the GI cancer space. With the conference in full swing, Clinical Trials Arena brings you the top developments within GI oncology to hit ASCO 2026 thus far.
RenovoRx’s drug-device combo prompts precision chemo delivery
With eyes firmly on the pancreatic cancer indication, RenovoRx has touted new pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase III TIGeR-PaC study (NCT03257033). The trial is currently assessing the potential of its RenovoCath dual balloon catheter for the intra-arterial delivery of chemotherapy agent, gemcitabine, to the tumour, which the company has designed to heighten the local potency of the drug, while diminishing off-target side effects linked to traditional intravenous delivery.
According to additional analyses, the maximum plasma drug concentration (Cmax) of gemcitabine’s inactive metabolite, difluorodeoxyuridine (dFdU), was higher in patients receiving gemcitabine intra-arterially, which RenovoRx says is “consistent with more rapid conversion of gemcitabine to dFdU” with targeted IAG over systemic IVG.
Additionally, researchers observed a direct correlation between increases in dFdU levels and a reduction in CA 19-9, a key protein tumour marker used to monitor pancreatic cancer – a feat which RenovoRx says could suggest that gemcitabine’s conversion to dFdU at the tissue level provides a surrogate marker for drug response when giving the chemotherapy agent intra-arterially.
According to the company, these PK/PD results could highlight the potential of intra-arterial gemcitabine delivery in reducing the systemic side effects linked to the drug, which include flu-like symptoms to nausea, vomiting, liver enzyme elevations and blood cell depletion.
Oricell’s HCC CAR-T demonstrates “best-in-class potential”
While CAR-T therapies have made their mark within the haematological cancer segment, they are yet to be widely used within solid tumours. However, Chinese biotech Oricell Therapeutics is looking to change this dynamic with its GPC3-targeted CAR-T therapy and lead candidate, Ori-C10, which saw a positive data readout in the Phase Ib BEACON study (NCT05652920) in late-line refractory hepatocellular carcinoma (HCC) at ASCO 2026.
During the trial, the objective response rate (ORR) was 50% within the 18 efficacy-evaluable patients, though the rate amongst patients receiving the recommended Phase II dose was 66.7%.
Oricell has also touted the durability of Ori-C10’s efficacy, with one patient achieving a complete response (CR) lasting 24 months after treatment.
Ori-C10’s safety profile was also manageable, with no patients experiencing immune effector cell-associated neurotoxicity syndrome (ICANS) or off-tumour toxicity – side effects commonly linked to CAR-T therapies. While patients did experience cytokine release syndrome (CRS), Oricell notes that these were “contained within controllable grades.”
According to Oricell, this readout could suggest the drug’s potential within the patient population that has already exhausted standard therapies.
The biotech presents this data a little after closing a $110m ‘pre-IPO’ round, which is funding its ongoing global expansion and clinical development. Oricell is currently gearing up to conduct pivotal trials with Ori-C101 in HCC. If approved, it would become the first CAR-T therapy to secure the regulatory green light in this indication.
CARsgen touts satri-cel long-term follow-up data
Another Chinese biotech aiming for CAR-T glory in the GI space is CARsgen Therapeutics, which is currently exploring the potential of its Claudin18.2-targeted therapy, satricabtagene autoleucel (satri-cel) in advanced gastric or gastroesophageal junction adenocarcinoma (GEJ).
At ASCO 2026, the company presented promising data from the open-label, investigator-initiated CT041-CG4006 (NCT03874897) trial, which was testing satri-cel’s potential as a sequential therapy after frontline treatment.
After treatment with the therapy, the four patients with target lesions all experienced a confirmed objective response (cOR), and the median duration of response (DoR) was not reached at the 18 October 2025 cutoff point, which marks a follow-up period of four and a half years. Meanwhile, the median progression-free survival (PFS) since first-line therapy was 20.9 months, and two patients who achieved clinical benefit then had surgery to remove their cancer after therapy with satri-cel. As of the data cutoff, both of these patients remained alive after 58.1 and 51.1 months.
Alongside its promising efficacy, albeit in a small cohort, patients treated with satri-cel did not experience CRS events of Grade 3 or higher, and there were no cases of ICANS at any grade after administration.
According to CARsgen, this long-term follow-up data highlights satri-cel’s “durable survival benefit with a manageable safety profile” in patients with both gastric and GEJ cancers – potentially supporting its clinical value in earlier treatment lines.
Avacta’s salivary gland cancer drug shows early promise
While the buzz around GI cancer readouts continues to grow, Avacta Therapeutics has debuted data around the safety, toxicity and preliminary efficacy of its peptide-drug conjugate (PDC), AVA6000, in salivary gland cancer.
In this first-in-human study (NCT04969835), researchers found that a “small fraction” of the active payload, doxorubicin, enters the bloodstream and reaches other unintended organs at lower concentrations than when patients receive intravenous treatment with the chemotherapy agent.
This is, in part, linked to a reduction in the rate of treatment-linked toxicities when using AVA6000 over traditional doxorubicin, despite the recommended dose for expansion being nearly three times higher than the maximum tolerated dose of the chemotherapy when it’s administered via the traditional intravenous path.
There were also no severe cardiac toxicity events reported, though four of the 111 patients dosed to date have experienced significant reductions in left ventricular ejection fraction (LVEF). Exposure-response analysis found no meaningful relationships between the changes in LVEF and the release of doxorubicin exposure.
The drug also demonstrated early signs of efficacy in this trial, with four partial and nine minor responses observed amongst the 38 evaluable patients, while the disease control rate (DCR) sits at 92%.
AVA6000 acts by reaching the tumour microenvironment, which often has upregulated expression of fibroblast activation protein-a (FAP). This extracellular protein then cleaves the pre|CISION peptide attached to AVA6000, activating doxorubicin to enter cells at the tumour site. This precision approach, Avacta says, holds the potential to reduce the off-target toxicities linked to doxorubicin.
These results come as there are no specifically approved treatment options for salivary gland cancer. In the US, there are approximately 2,000 to 2,500 cases of salivary gland cancer reported each year.
