Following are key take‑home messages from ESMO GI 2025 (Barcelona, 2–5 July), organized by cancer type.
Colorectal Cancer (CRC)
Botensilimab + Balstilimab in MSS metastatic CRC
- In microsatellite‑stable (MSS) metastatic colorectal cancer—usually unresponsive to immunotherapy—a Phase 1b trial (C‑800‑01) enrolled 123 previously treated patients without active liver metastases.
- The combination achieved a 20% confirmed response rate, including some complete remissions. Median overall survival was 20.9 months, with about 42% of patients alive at 2 years, a meaningful improvement over the typical 6–10 month outcomes in this setting.
- Responses were durable—the median duration was 16.6 months, and about 20% of patients were alive and off therapy at 18 months.
- Side effects included immune-related events (e.g., diarrhea/colitis) in about 58% of patients, mostly manageable, with no treatment-related deaths.
- The FDA has cleared the design for a global Phase 3 BATTMAN trial, without requiring a botensilimab-only control arm—streamlining the approval path.
EGFR inhibitor rechallenge
New data reconfirm that patients whose tumors previously responded to EGFR-targeted therapy (e.g. cetuximab) may benefit from re-treatment after a treatment break—especially if the interval is long. This suggests a rechallenge strategy may become part of future standard care once stronger trial support accumulates.
NALIRIFOX: Liposomal Irinotecan Combo
A Phase I study of the liposomal form of irinotecan combined with FOLFOX ± bevacizumab or cetuximab achieved an 82% response rate and disease control in nearly all participants, with average PFS over 11 months. Larger trials are planned to confirm these promising results.
ctDNA monitoring for surveillance
Circulating tumor DNA (ctDNA) tests appear more sensitive than traditional blood markers for detecting colorectal cancer recurrence or guiding follow‑up. These findings support using ctDNA to tailor follow-up strategies after surgery or systemic therapy.
Nivolumab + Ipilimumab vs Nivolumab alone
- The CheckMate 8HW trial reaffirmed that combining two immunotherapy drugs (nivolumab and ipilimumab) offers better disease control and quality of life compared to nivolumab alone in patients with MSI-high/dMMR metastatic CRC.
- This supports continued use of the combo as a preferred first-line treatment for eligible patients.
Gastric / Gastro‑oesophageal Cancer (GEC)
Novel bispecific antibody therapy
- A new agent called givastomig (targets claudin 18.2 and stimulates 4‑1BB) shown in early data combined with chemotherapy and nivolumab reached a 71% response rate in metastatic gastric cancer.
- Safety is promising; larger trials are needed to confirm benefit and guide integration into care.
Pancreatic Cancer (PDAC)
Certepetide added to standard chemotherapy
- Pairing certepetide with gemcitabine + nab‑paclitaxel modestly improved outcomes over chemo alone: response rate ~33%, with longer median PFS (~7.5 vs ~4.5 months) and OS (10.3 vs 9 months).
- Encouraging but preliminary—confirmation in larger trials is awaited.
Tumor Treating Fields (TTFields) via PANOVA‑3
- Electrical “TTFields” added to chemo improved survival, reduced pain, and lowered opioid use, leading to better quality of life in locally advanced pancreatic cancer.
- If validated in broader use, this could become a supportive-care standard for eligible patients.
Liver / Hepatocellular Carcinoma (HCC)
Irpagratinib + Atezolizumab in FGF19‑positive HCC
- Patients whose tumors overexpress FGF19—a subgroup with poor prognosis—were treated with a FGFR4 inhibitor (irpagratinib) plus anti‑PD‑L1 (atezolizumab).
- The study showed a ~50% response rate, median PFS ~7–8 months, and appeared well tolerated in both first-line and pretreated patients.
Combining TACE with Atezolizumab + Bevacizumab (TALENTACE)
- Adding locoregional therapy (TACE) plus systemic immunotherapy (atezolizumab + bevacizumab) improved response rates (49% vs 34%) and PFS (11.3 vs 7.0 months) compared to TACE alone.
- There’s a positive trend in overall survival (34 vs 25 months), with full data still maturing.
Durvalumab + Tremelimumab safety update
- Safety data from the SIERRA study showed acceptable tolerability in poor-prognosis HCC patients; more time is needed to assess efficacy.
Biliary Tract / Cholangiocarcinoma
PARP inhibitor olaparib in biliary tract cancer
- Early signals suggest olaparib, typically used in other cancers, may benefit biliary tract cancers, especially those with DNA repair mutations.
- Larger studies are ongoing to determine its role.
Ivosidenib in IDH1-mutated cholangiocarcinoma
- In patients whose tumors carry an IDH1 mutation, ivosidenib showed encouraging activity, pointing toward molecularly targeted treatment options in this subgroup.
Molecular / Screening & Emerging Tech
ctDNA & RNA-based screening for colorectal cancer
- Innovative blood tests detecting both DNA and RNA may make CRC screening more accessible and acceptable, especially for those avoiding colonoscopy.
- This could improve early detection in broader populations.
Advanced imaging and robotics for early detection and removal
- Techniques like multi‑contrast laser endoscopy (not detailed here) and robotic control for endoscopic tumor removal are under study, aiming to improve early lesion detection and safer excision.
Treatment Guidelines & Forward Look
- ESMO “Living Guidelines” are already updated for metastatic colorectal, gastric, and liver cancers (late 2024 / early 2025). These evolve as new trial evidence becomes available.
- Trials like botensilimab/balstilimab in MSS CRC, EGFR rechallenge, ctDNA surveillance, and novel immunotherapies may inform future guideline updates.
- Personalized approaches—like molecular profiling (e.g. FGF19, IDH1) and patient-derived tumor drug testing—are becoming central to modern GI oncology.
What It Means to You
Many of these findings are early phase—promising but not yet standard of care. Still, they represent real steps forward, especially in resistant cancers like MSS CRC or targeted subtypes like FGF19-positive HCC.
If you’re navigating a diagnosis or treatment plan:
- Ask about molecular testing—knowing details like MSI status, IDH1, FGF19, RAS mutations can open new tailored options.
- Discuss trial eligibility—some hospitals offer studies like BATTMAN (botensilimab), TTFields, or targeted therapies.
- Consider ctDNA monitoring—it may offer more precise follow-up after treatment.
- Explore immunotherapy combos—such as nivolumab + ipilimumab for MSI-high CRC, which remain backed by strong evidence.
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