๐ฌ GI Cancer Intelligence Digest โ Week 2026-W27
China approved satri-cel as the first CAR-T for a solid tumor in gastric/GEJ cancer, the EC approved encorafenib+cetuximab+FOLFOX in 1L BRAF V600E mCRC, and triple IO in HCC and STELLAR-303 in refractory mCRC reported readouts.
โก TL;DR
๐ Publications
- Non-thermal focused ultrasound with FOLFIRINOX for borderline resectable or locally advanced pancreatic cancer: An explorative phase II trial. โ ORR 64.3% vs 35.7% with FUS plus FOLFIRINOX vs FOLFIRINOX alone (P=0.003)
- Targeting Phosphatidylserine in Advanced Gastric and Gastroesophageal Junction Adenocarcinomas: A Phase 2 Trial of Bavituximab Plus Pembrolizumab with Biomarker-Correlated Outcomes. โ ORR 13.1% in CPI-naรฏve and 5.3% in CPI-relapse patients
- Addition of ipilimumab to atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (PRODIGE 81-FFCD 2101-TRIPLET HCC): phase 2 results from a randomised, multicentre, open-label, phase 2-3 trial. โ At 24 weeks, 34 (30%) responded with triple therapy vs 31 (27%) with atezolizumab plus bevacizumab
- Mutant KRAS peptide vaccine with dual checkpoint blockade in metastatic colorectal cancer: a phase I trial. โ mKRAS-VAX elicited mKRAS-reactive T-cells in 8/12 biomarker-evaluable patients (75%) ex vivo and 12 patients (100%) after expansion
- Fusobacterium periodonticum promotes colorectal tumorigenesis via decanoic acid-driven neutrophil chemotaxis. โ F. periodonticum is enriched in colorectal cancer patients and correlated with elevated decanoic acid
๐ฆ Twitter / ๐ฆ Bluesky
- China approves satri-cel, the first CAR-T ever for a solid tumor in gastric/GEJ cancer โ Median PFS 3.25 vs 1.77 months (HR 0.37) and median OS 7.9 vs 5.5 months (HR 0.69) in CT041-ST-01
- European Commission approves encorafenib + cetuximab + FOLFOX in 1L BRAF V600E mCRC โ EC approval based on BREAKWATER showing improved PFS (12.8 vs 7.1 months) and a 51% reduction in risk of death
- PRODIGE 81-TRIPLET HCC: adding ipilimumab to atezolizumab plus bevacizumab fails โ At 24 weeks, 30% responded with the triple combination vs 27% with atezolizumab plus bevacizumab
- STELLAR-303: zanzalintinib plus atezolizumab edges regorafenib in refractory MSS mCRC โ Zanzalintinib + atezolizumab improved OS vs regorafenib in the ITT population, mOS 10.9 vs 9.4 months, HR 0.80, P=0.0045
- Update: daraxonrasib gains FDA Expanded Access in KRAS-mutated pancreatic cancer โ Daraxonrasib received FDA Expanded Access for KRAS-mutated pancreatic cancer ahead of full approval
Full details below โ
๐ What's Being Published
Non-thermal focused ultrasound with FOLFIRINOX for borderline resectable or locally advanced pancreatic cancer: An explorative phase II trial. โ Lee Dong Ho et al., Eur J Cancer
In this phase II trial, ORR was higher with FUS plus FOLFIRINOX than with FOLFIRINOX alone (64.3% vs. 35.7%; P = 0.003). Median OS was 24.0 versus 17.0 months (HR 0.63; 95% CI, 0.41โ0.97; P = 0.029), and median PFS was 16.0 versus 11.0 months (HR 0.65; 95% CI, 0.43โ0.99; P = 0.039). Grade โฅ3 toxicities occurred in 55.4% and 57.1% of patients (P = 0.849), with no FUS-related or collateral organ injuries.
Clinical bottom line: Adding non-thermal focused ultrasound to FOLFIRINOX improved response and survival without added toxicity in borderline resectable or locally advanced pancreatic cancer, supporting a randomized phase III test.
Targeting Phosphatidylserine in Advanced Gastric and Gastroesophageal Junction Adenocarcinomas: A Phase 2 Trial of Bavituximab Plus Pembrolizumab with Biomarker-Correlated Outcomes. โ Ntellas Panagiotis et al., Curr Oncol
The ORR was 13.1% in CPI-naรฏve and 5.3% in CPI-relapse patients; the median duration of response was 12.5 months in the CPI-naรฏve cohort. Higher ORRs were observed in patients with immune-high (B+) subtypes (21.9%), NLR < 4 (17.9%), and B+/NLR < 4 (33%).
Clinical bottom line: Bavituximab plus pembrolizumab was well tolerated but showed only modest activity in advanced gastric/GEJ adenocarcinoma, with benefit concentrated in biomarker-defined subgroups.
Addition of ipilimumab to atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (PRODIGE 81-FFCD 2101-TRIPLET HCC): phase 2 results from a randomised, multicentre, open-label, phase 2-3 trial. โ Merle Philippe et al., Lancet Gastroenterol Hepatol
At 24 weeks, 34 (30% [80% CI 24โ36]) patients in the atezolizumab plus bevacizumab plus ipilimumab group had an objective response, as had 31 (27% [22โ34]) patients in the atezolizumab plus bevacizumab group. Treatment-related adverse events resulting in death occurred in six (5%) patients in the triple combination group and none in the doublet group.
Clinical bottom line: Adding low-dose ipilimumab to atezolizumab plus bevacizumab did not improve outcomes in untreated unresectable HCC, and the trial was stopped without progressing to phase 3.
Mutant KRAS peptide vaccine with dual checkpoint blockade in metastatic colorectal cancer: a phase I trial. โ Wang Hejia Henry et al., Nat Commun
mKRAS-VAX elicited an increase in tumor-specific mKRAS-reactive T-cells in 8/12 biomarker-evaluable patients (75%) by direct ex vivo IFNฮณ ELISpot and in 12 patients (100%) following in vitro expansion. All adverse events attributed to mKRAS-VAX were grade 1 or 2, and the addition of mKRAS-VAX did not increase the frequency of severe immune-related adverse events beyond the expected profile of dual checkpoint inhibitors alone.
Clinical bottom line: A pooled mutant KRAS peptide vaccine with nivolumab and ipilimumab was safe and immunogenic in pretreated MMRp/MSS CRC, supporting further development of mKRAS vaccines with checkpoint inhibitors.
Fusobacterium periodonticum promotes colorectal tumorigenesis via decanoic acid-driven neutrophil chemotaxis. โ Jia Xinmiao et al., Nat Commun
Fusobacterium periodonticum is significantly enriched in colorectal cancer patients and strongly correlated with elevated decanoic acid levels. Decanoic acid intervention promotes tumor progression by facilitating neutrophil infiltration and modulating the local immune microenvironment.
Clinical bottom line: F. periodonticum drives colorectal tumorigenesis through decanoic acid-mediated neutrophil chemotaxis, identifying a microbe-metabolite-immune axis in CRC pathogenesis.
๐ฃ๏ธ What People Were Discussing This Week
How these are chosen: filtered for clinical relevance, grouped by the new development discussed, then ordered by engagement (bookmarks and reposts).
China approves satri-cel, the first CAR-T ever for a solid tumor in gastric/GEJ cancer
China's NMPA approved satri-cel for patients with advanced CLDN18.2+/HER2โ gastric/GEJ adenocarcinoma after at least 2 prior lines of therapy, making it the first CAR-T authorized for a solid tumor. In the CT041-ST-01 trial, median PFS was 3.25 vs 1.77 months (HR 0.37) and median OS was 7.9 vs 5.5 months (HR 0.69), with 18-month OS of 20% vs 10%. The HR 0.37 corresponds to a 63% reduction in risk of progression or death (p<0.0001). Specialists are debating whether this approval establishes CAR-T as a scalable platform for solid tumors or whether it remains a niche third-line gastric option.
Discussed by: @GIMedOnc, @YLeyfman, @BLLPHD
European Commission approves encorafenib + cetuximab + FOLFOX in 1L BRAF V600E mCRC
The European Commission approved encorafenib plus cetuximab plus FOLFOX for first-line BRAF V600E metastatic colorectal cancer, marking the first BRAF-targeted regimen authorized in Europe for previously untreated patients. The approval was based on the phase 3 BREAKWATER trial, which showed significant improvements in objective response rate and progression-free survival (12.8 vs 7.1 months), reducing the risk of death by 51% versus standard oxaliplatin-based chemotherapy, with or without bevacizumab. Whether this combination will become the universal 1L standard across BRAF V600E mCRC is now the central question for oncologists.
Discussed by: @MarioBalsaMD, @p_ciracimd
PRODIGE 81-TRIPLET HCC: adding ipilimumab to atezolizumab plus bevacizumab fails
In the PRODIGE 81-FFCD 2101-TRIPLET HCC trial, at 24 weeks, 34 (30% [80% CI 24โ36]) patients in the atezolizumab plus bevacizumab plus ipilimumab group had an objective response, compared with 31 (27% [22โ34]) patients in the doublet group. The addition of ipilimumab to atezolizumab plus bevacizumab did not show any benefit in patients with previously untreated, unresectable hepatocellular carcinoma, and treatment-related deaths occurred in six (5%) patients in the triple arm versus none in the doublet arm. Clinicians are considering whether the failure of low-dose ipilimumab atop atezo-bev closes the door on first-line triple immunotherapy in HCC.
Discussed by: @LancetGastroHep, @Erman_Akkus
STELLAR-303: zanzalintinib plus atezolizumab edges regorafenib in refractory MSS mCRC
In the STELLAR-303 trial, zanzalintinib plus atezolizumab improved OS versus regorafenib in the ITT population, with a median OS of 10.9 months vs 9.4 months (HR 0.80; P = 0.0045). However, zanzalintinib plus atezolizumab did not significantly improve OS versus regorafenib in the non-liver metastases subgroup of patients with previously treated non-MSI-H metastatic colorectal cancer. Oncologists are weighing whether a roughly 1.5-month OS gain is sufficient to position an IO/TKI combination as a meaningful new option in refractory MSS CRC.
Discussed by: @SpenceLessansMD, @MPishvaian, @HannahAlison20
Update: daraxonrasib gains FDA Expanded Access in KRAS-mutated pancreatic cancer
Daraxonrasib received FDA Expanded Access for KRAS-mutated pancreatic cancer โ not full approval, but patients can access it now while phase 3 trials run. Data from RASolute 302 showed 13.2 months median survival versus 6.7 months with chemotherapy. The central question for clinicians is how Expanded Access will reshape patient access to daraxonrasib before phase 3 confirmation and full approval.
Discussed by: @Oncology_Love, @stolaney1, @fernandbteich
๐ฅ Top Ranked Tweets
OncoAlert @OncoAlert
RT @OncoAlert: News From Industry
BREAKWATER Update in #ColorectalCancer
Source PR NewsWire
https://t.co/FTmj9ppf0d
Laboratoires Pierre Fabre announced European Commission approval of encorafenib plus cetuximab and FOLFOX as first-line treatment for adults with BRAFV600E-mutant metastatic colorectal cancer. The decision is based on the Phase 3 BREAKWATER trial, which showed significant improvements in objective response rate, progression-free survival (12.8 vs 7.1 months), and overall survival, reducing the risk of death by 51% versus standard oxaliplatin-based chemotherapy, with or without bevacizumab.
Pinging
@pashtoonkasi @CathyEngMD @marklewismd @AndresC27622123 @manjuggm @stacy_hurt @ARosen380 @KoheiShitara @GillSharlene @BenWestphalen
@graokane @nataliagandur @acampsmalea @BRicciutiMD
@HHorinouchi @FernandoOnco @ElisaAgostinett @to_be_elizabeth @realbowtiedoc @Erman_Akkus @MarioBalsaMD @DrMirallas @GIMedOnc @DaisukeKotani @DraMartinezLago @p_ciracimd @DrVilmaPBarcia
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OncoAlert @OncoAlert
News From Industry
BREAKWATER Update in #ColorectalCancer
Source PR NewsWire
https://t.co/FTmj9ppf0d
Laboratoires Pierre Fabre announced European Commission approval of encorafenib plus cetuximab and FOLFOX as first-line treatment for adults with BRAFV600E-mutant metastatic colorectal cancer. The decision is based on the Phase 3 BREAKWATER trial, which showed significant improvements in objective response rate, progression-free survival (12.8 vs 7.1 months), and overall survival, reducing the risk of death by 51% versus standard oxaliplatin-based chemotherapy, with or without bevacizumab.
Pinging
@pashtoonkasi @CathyEngMD @marklewismd @AndresC27622123 @manjuggm @stacy_hurt @ARosen380 @KoheiShitara @GillSharlene @BenWestphalen
@graokane @nataliagandur @acampsmalea @BRicciutiMD
@HHorinouchi @FernandoOnco @ElisaAgostinett @to_be_elizabeth @realbowtiedoc @Erman_Akkus @MarioBalsaMD @DrMirallas @GIMedOnc @DaisukeKotani @DraMartinezLago @p_ciracimd @DrVilmaPBarcia
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OncoAlert @OncoAlert
RT @p_ciracimd: โผ๏ธ The European Commission has approved encorafenib + cetuximab and FOLFOX for the first-line treatment of BRAF-V600E mut mCRC patients, based on the results of the BREAKWATER study. @OncoAlert
https://t.co/TAxfPasm8R
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OncoAlert @OncoAlert
RT @MarioBalsaMD: ๐จ The European Commission has approved encorafenib + cetuximab + FOLFOX for the 1L treatment of BRAF V600Em M1 CRC, marking the first BRAF-targeted regimen authorized in Europe for previously untreated patients! Based on the phase III BREAKWATER trial ๐ฏ
https://t.co/8MhZTmXllm
A major milestone for precision oncology and long-awaited progress for one of the most aggressive molecular subsets of mCRC ๐ฅ
BREAKWATER didnโt just break the water. It opened the floodgates ๐
@OncoAlert
@OncoReporte @myESMO @_SEOM @GrupoTTD
#mCRC #ColorectalCancer #BRAF #PrecisionOncology #BREAKWATER
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OncoAlert @OncoAlert
RT @GIMedOnc: A historic day for solid tumor oncology.
China has approved satri-cel (CLDN18.2 CAR-T) for advanced gastric/GEJ cancer, making it the first CAR-T therapy ever approved for a solid tumor. For years, CAR-T has transformed hematologic malignancies while solid tumors remained left in the dust.
๐ CT041-ST-01 (3L+ CLDN18.2+ gastric/GEJ cancer) in the Lancet
โข Median PFS: 3.25 vs 1.77 months (HR 0.37)
โข Median OS: 7.9 vs 5.5 months (HR 0.69)
โข 18-month OS: 20% vs 10%
โข Demonstrated superiority over physicianโs choice therapy in a heavily pretreated population.
The absolute numbers are not dramatic, but that isnโt the point.
This is the first regulatory approval of a CAR-T for a solid tumor.
Also notable: this happened in China, not the United States.
As China continues to accelerate development of cell therapies, ADCs, and other oncology platforms, it is increasingly becoming the site of first-in-class innovation.
Satri-cel may ultimately be remembered less for the 2.4-month OS gain and more for what it represents:
The beginning of the solid tumor CAR-T era.
@Onco_Nexus @OncoAlert @TheGutOncLab
https://t.co/gon4I3udIR
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CancerNetworkยฎ @CancerNetwrk
The European Commission has approved encorafenib with cetuximab and FOLFOX in 1L BRAF V600E+ metastatic colorectal cancer.
โฌ๏ธ For more โฌ๏ธ
https://t.co/viDaL5MUfQ
#crcsm #oncology #cancer https://t.co/O1Kqonpmlo
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Elad Sharon @EladSharonMD
RT @sonbol_bassam: Phase 3 data from FIGHT-302 just published in @JCO_ASCO, led by @GIcancerDoc
In FGFR2-rearranged cholangiocarcinoma, pemigatinib vs Gem/Cis showed:
โข Improved PFS (8.3 vs 6.8 mo)
โข Higher ORR (47% vs 15%)
โข More durable responses (14.2 vs 6.3 mo)
โข Similar OS (24.4 vs 25.0 mo)
The trial closed early after the standard of care shifted with TOPAZ-1 and KN-966.
https://t.co/9fv6gsSsUC
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Jennifer A. Marks, MD @jennifermarksmd
RT @GIMedOnc: China approves the worldโs first CAR-T therapy for a solid tumor.
Hours later, the FDA responds with full approval of afami-cel and expansion into pediatric synovial sarcoma.
A remarkable day for cellular therapy.
๐จ๐ณ Satri-cel (CLDN18.2 CAR-T)
CT041-ST-01, refractory gastric/GEJ cancer
โข PFS: 3.25 vs 1.77 months (HR 0.37)
โข OS: 7.9 vs 5.5 months (HR 0.69)
โข 18-month OS: 20.1% vs 8.6%
โข First CAR-T ever approved for a solid tumor
๐บ๐ธ Afami-cel (MAGE-A4 TCR-T)
SPEARHEAD-1, advanced synovial sarcoma
โข ORR: 43%
โข CR: 4.5%
โข Median DoR: 6.0 months
โข Median OS: 15.4 months
โข First FDA-approved engineered cellular therapy for a solid tumor
For decades, solid tumors were where cellular therapies went to fail.
Now, on the same day, regulators in China and the United States have approved two different engineered T-cell platforms for two different solid tumors.
A brave new world for solid tumor oncology.
Any cancer center not providing cellular therapies is going to be left in the dust.
@OncoAlert @TheGutOncLab @Onco_Nexus
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Elad Sharon @EladSharonMD
RT @BLLPHD: Important milestone for the field: CARsgenโs satri-cel, an autologous Claudin18.2 CAR T, has been approved in China for Claudin18.2+ HER2- advanced gastric/GEJ adenocarcinoma after โฅ2 prior lines.
CAR T has transformed blood cancers. Solid tumors have been the harder frontier: trafficking, persistence, antigen heterogeneity, and the tumor microenvironment.
This approval does not mean the problem is solved, but it shows that engineered T cells can make it across the solid tumor line. Now the work turns to durability, safety, access, earlier lines, combinations, and whether this can extend to other Claudin18.2+ tumors. https://t.co/wM51eh5Vz4
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Allison Betof, MD, PhD, FASCO @DrBetofMDPhD
RT @YLeyfman: ๐ฏ A historic milestone for CAR T-cell therapy in solid tumors.
The Phase II CT041-ST-01 trial reports the first positive randomized controlled study of a CAR T-cell therapy in a solid tumor, demonstrating significant clinical benefit in heavily pretreated patients with CLDN18.2-positive gastric and gastroesophageal junction cancers.
Key findings:
โ Median progression-free survival (PFS): 3.25 vs 1.77 months
โ 63% reduction in risk of progression or death (HR 0.37; p<0.0001)
โ Benefit observed in a population with substantial unmet need, including a high proportion of patients with peritoneal metastases and multiple prior lines of therapy
Satricabtagene autoleucel (satri-cel/CT041) targets CLDN18.2, an emerging biomarker and therapeutic target in gastric cancer. The study provides the strongest evidence to date that CAR T-cell therapy can overcome some of the longstanding challenges of treating solid tumors.
Safety was consistent with expectations for CAR T-cell therapy:
โข Cytokine release syndrome (CRS): 95% (predominantly manageable)
โข Grade โฅ3 treatment-emergent adverse events were common, largely reflecting lymphodepletion and hematologic toxicity
While longer follow-up and overall survival data remain important, these results represent a landmark advance for cellular therapy beyond hematologic malignancies and may establish satri-cel as a new third-line treatment option for patients with advanced gastric cancer.
The success of CT041 raises an important question: Are we finally seeing the first scalable CAR T-cell platform for solid tumors?
#GastricCancer #CARTCellTherapy #CellTherapy #Oncology #Immunotherapy #SolidTumors #PrecisionOncology #GastroesophagealCancer #CancerResearch #ClinicalTrials
https://t.co/4P3OEKeI4R
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Yuji Uehara, MD, PhD @DrYujiUehara
RT @GIMedOnc: A historic day for solid tumor oncology.
China has approved satri-cel (CLDN18.2 CAR-T) for advanced gastric/GEJ cancer, making it the first CAR-T therapy ever approved for a solid tumor. For years, CAR-T has transformed hematologic malignancies while solid tumors remained left in the dust.
๐ CT041-ST-01 (3L+ CLDN18.2+ gastric/GEJ cancer) in the Lancet
โข Median PFS: 3.25 vs 1.77 months (HR 0.37)
โข Median OS: 7.9 vs 5.5 months (HR 0.69)
โข 18-month OS: 20% vs 10%
โข Demonstrated superiority over physicianโs choice therapy in a heavily pretreated population.
The absolute numbers are not dramatic, but that isnโt the point.
This is the first regulatory approval of a CAR-T for a solid tumor.
Also notable: this happened in China, not the United States.
As China continues to accelerate development of cell therapies, ADCs, and other oncology platforms, it is increasingly becoming the site of first-in-class innovation.
Satri-cel may ultimately be remembered less for the 2.4-month OS gain and more for what it represents:
The beginning of the solid tumor CAR-T era.
@Onco_Nexus @OncoAlert @TheGutOncLab
https://t.co/gon4I3udIR
๐ 45 โค๏ธ 155 ๐ 41 ๐ 24,004
ClinicalOncologyNews @ClinOncNews
Big shift in stage III dMMR colon cancer care ๐
Adjuvant atezolizumab + mFOLFOX6 cut recurrence/death risk by ~50% vs chemo alone (HR 0.50).
3-year DFS: 86% vs 76%.
Could immunotherapy now be the new adjuvant standard? https://t.co/Pkj97aaoeh
#ColorectalCancer #Oncology https://t.co/SJMlJBvL0n
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OncLive.com @OncLive
For the first time, a CAR T-cell therapy is approved for the treatment of solid tumors. China's NMPA approved satri-cel for patients with advanced CLDN18.2+/HER2โ gastric/GEJ adenocarcinoma after at least 2 prior lines of therapy #oncology
Read more: https://t.co/Vx1WwV3FZI https://t.co/hTRrpqngTf
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OncLive.com @OncLive
๐ช๐บ CHMP has has issued a positive opinion for encorafenib plus cetuximab and mFOLFOX6 in first-line BRAF V600Eโmutant mCRC supported by results from the phase 3 BREAKWATER trial.
Full details ๐: https://t.co/bcX8Ltertv
#oncology #crcsm
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Gastroenterology & Endoscopy News @gastroendonews
Big moment in pancreatic cancer.
Daraxonrasib doubled overall survival vs chemo in metastatic PDAC at #ASCO2026โand brings the first major shift in years: https://t.co/GsROLw97Xo #oncology https://t.co/wngFp2WBNV
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