5-fluorouracil / Generic mfg. - LARVOL DELTA

BREAKWATER: Primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P3 | "Background: Leucovorin/5-FU in combination with oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) are common chemotherapies used in 1L mCRC. In patients (pts) with BRAF V600E-mutant mCRC, the Phase 3 portion of BREAKWATER (NCT04607421) demonstrated clinically meaningful and statistically significantly improved ORR by blinded independent central review (BICR), PFS by BICR, and OS with 1L EC + mFOLFOX6 vs chemotherapy ± bevacizumab (bev) (Kopetz Nat Med 2025; Elez N Engl J Med 2025)... BREAKWATER Cohort 3 demonstrated a clinically meaningful and statistically significant improved response rate that was rapid and durable with EC+FOLFIRI vs control in 1L BRAF V600E-mutant mCRC, with manageable toxicities and no new safety signals. These data support EC+FOLFIRI as a potential new standard of care in BRAF V600E-mutant mCRC. aBy BICR."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. (PubMed, Lancet) - P3 | "Perioperative durvalumab plus FLOT improved overall survival versus placebo plus FLOT and is a new standard treatment option for patients with resectable gastric or gastro-oesophageal junction adenocarcinoma."

IO biomarker • Journal • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • PD-L1

Induction Paclitaxel-Cisplatin-Capecitabine for Nasopharyngeal Carcinoma. (PubMed, NEJM Evid) - P3 | "Among patients with high-risk LA-NPC, TPC induction chemotherapy was associated with higher 5-year FFS than PF. (Funded by National Natural Science Foundation of China and State Key Laboratory of Respiratory Disease; ClinicalTrials.gov number, NCT02940925.)."

Clinical • Journal • Epstein-Barr Virus Infections • Nasopharyngeal Carcinoma • Oncology • Respiratory Diseases • Solid Tumor

FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for taxane-pretreated patients with advanced or metastatic gastroesophageal adenocarcinoma–Final results of the phase III IKFs602/AIO RAMIRIS Study (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

IROCAS: A randomized phase III trial of adjuvant treatment intensification with mFOLFIRINOX versus mFOLFOX6 in high-risk stage III (T4 and/or N2) colon cancer. (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Initial Experience with Intratumoral Phosphorus-32 Microparticle Injection in Pancreatic Adenocarcinoma (EANM 2026) - "Materials and Seven patients with pancreatic adenocarcinoma underwent endoscopic ultrasound-guided intratumoral P-32 microparticle injection in combination with FOLFIRINOX-based neoadjuvant chemotherapy... In this preliminary single-center experience, intratumoral P-32 microparticle injection in combination with neoadjuvant chemotherapy in pancreatic adenocarcinoma was feasible, well tolerated, and successfully followed by surgery in most patients. Durable local control was observed across the cohort. Although the small sample size precludes definitive conclusions regarding oncologic efficacy, the high resection rate and favorable early safety profile support further evaluation of this approach as a local treatment intensification strategy within multimodal therapy for pancreatic adenocarcinoma."

Oncology • Pancreatic Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

Prognostic Value of Tc-99m MAA Hepatic Arterial Perfusion Imaging in Patients with Advanced Hepatocellular Carcinoma Receiving with Hepatic Arterial Infusion Chemotherapy. (EANM 2026) - "Materials and A total of 111 patients with advanced HCC received with 5-fluorouracil-based HAIC were retrospectively analyzed... HAPI with PI is significantly associated with overall survival in patients with advanced HCC receiving with HAIC. HAPI may serve as a clinically useful prognostic role for treatment stratification and outcome prediction."

Clinical • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor

Second-Line Systemic Therapy Following First-Line FOLFIRINOX or NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma: A Systematic Review and Meta-Analysis. (PubMed, J Gastrointest Cancer) - "This first contemporary synthesis of post-triplet second-line therapy in mPDAC shows meaningful benefit in carefully selected, fit patients. Gemcitabine-based combination therapy is a reasonable option for ECOG 0-1 patients, though treatment should remain individualized based on performance status, toxicity, and preference. These findings provide contemporary benchmarks for practice and future trials."

Clinical • Journal • Retrospective data • Review • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Comment on "Effects of the Administration of Probiotic Complexes of Bacillus coagulans and Clostridium butyricum on Intestinal Barrier Damage Induced by 5-Fluorouracil in Rats". (PubMed, Clin Nutr ESPEN) - No abstract available

Journal • Preclinical

Unraveling the Mechanisms of Chemoresistance in Gastric Cancer: Insights and Emerging Research Strategies. (PubMed, Curr Oncol Rep) - "Platinum‑based drugs, fluoropyrimidines, and docetaxel are standard for advanced disease, but intrinsic and acquired resistance limit the efficacy...Collectively, the interplay between cell death pathways and the ncRNA regulatory networks profoundly influences chemoresistance in GC. Deciphering these mechanisms offers a theoretical basis for developing biomarkers and combination strategies that overcome resistance, ultimately improving patient outcomes."

Journal • Review • Gastric Cancer • Oncology • Solid Tumor • BCL2 • GPX4 • SLC7A11

Prognostic Value of Neutrophil-to-Lymphocyte Ratio in Therapy Selection for High-Risk Stage II Colon Cancer. (PubMed, Chirurgia (Bucur)) - "Preoperative NLR is a strong and independent prognostic marker in high-risk stage II MSS colon cancer. Patients with high NLR appear to benefit more from oxaliplatin-containing adjuvant chemotherapy, potentially due to its immunogenic effects. NLR may serve as a simple, cost-effective tool for refining adjuvant therapy decisions in this challenging patient population."

Journal • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Cognitive Aging 20 to 35 Years After Adjuvant Chemotherapy in Breast Cancer Survivors (EANO 2026) - "Objective: To assess whether long-term breast cancer survivors treated with adjuvant cyclophosphamide-methotrexate-fluorouracil (CMF) differ from cancer‑free controls in cognitive performance and rate of decline 20-35 years post‑treatment. Survivors performed significantly worse than controls on 11 of 15 outcomes at baseline, approximately 20 years after treatment, and showed significantly faster decline on 11 of 15 outcomes over the next 15 years, though not consistently on the same tests. Accelerated decline corresponded to reaching a 0.5‑SD drop 2-4 years earlier than controls across verbal learning, memory, processing speed, and a general cognitive factor. Conclusion and Relevance: More than 30 years after CMF chemotherapy, breast cancer survivors exhibited lower cognitive performance and faster decline than cancer‑free controls."

Clinical • Breast Cancer • Oncology • Solid Tumor

BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: Lisata Therapeutics, Inc. | Terminated ➔ Completed

Trial completion • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Evaluation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Localized Pancreatic Cancer: Trans-Atlantic Pancreatic Surgery Consortium Study. (PubMed, Ann Surg Oncol) - "Individual-level surrogacy between PFS and OS did not meet the prespecified threshold for good surrogacy due to considerable interpatient variability in post-progression survival, supporting the continued use of OS as the gold-standard efficacy endpoint in clinical trials. However, surrogacy was stronger among patients with lower pretreatment tumor burdens and more favorable pathologic responses, potentially facilitating perioperative treatment development through shorter follow-up periods in pancreatic cancer trials."

Clinical • Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Evaluation of BOLD-100 as a Strategy to Overcome Drug Resistance in Multiple Myeloma (IMS 2026) - "A Phase 2 trial with FOLFOX reported reduced oxaliplatin-associated neuropathy, suggesting a potential neuroprotective effect worthy of exploration in MM... Isogenic MM cell lines including PI-sensitive (S), bortezomib-resistant (BR), and carfilzomib-resistant (CR) derivatives of AMO-1, RPMI-8226, U266 and OPM2 were used... Taken together, these findings position BOLD-100 as a clinically relevant strategy in PI-resistant myeloma. GRP78 suppression and UPR collapse provide a mechanistically coherent basis for PI synergy, and persistence in resistant models is important given the unmet need in relapsed/refractory disease. The neuronal findings, while early, are encouraging."

Hematological Malignancies • Multiple Myeloma • ATF4 • ATF6 • BDNF • CASP3 • HSPA5

MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and modified FOLFOX6 as first line treatment in HER2+ metastatic colorectal cancer. (ASCO 2023) - P2, P3 | "Approximately 400 patients will be randomized 1:1 to the TUC experimental arm (TUC [300 mg orally twice daily] + Tras + mFOLFOX) or the SOC arm (mFOLFOX alone or in combination with either bevacizumab or cetuximab)...Enrollment is ongoing in North America, Asia, Australia, and Europe. Clinical trial information: NCT05253651."

Clinical • Metastases • P3 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRAF • HER-2

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

First-line (1L) encorafenib + cetuximab + mFOLFOX6 in East Asian patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC): Results from the phase III BREAKWATER study (ESMO Asia 2025) - P3 | "Background: The randomized phase 3 BREAKWATER study (NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR by blinded independent central review (BICR), PFS by BICR, and OS with encorafenib + cetuximab (EC) + mFOLFOX6 vs control (chemotherapy ± bevacizumab) in 1L BRAF V600E-mutant mCRC (Kopetz, Nat Med 2025; Elez, N Engl J Med 2025)... Consistent with the global study results, East Asian pts with untreated BRAF V600E-mutant mCRC attained clinically significantly improved ORR, PFS, and OS with EC+mFOLFOX6 vs control therapy. The treatment safety profiles in East Asian pts were consistent with those observed in the overall population and as expected for each agent."

Clinical • Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

FOLFOX Plus Bevacizumab Rechallenge Versus Regorafenib as Third-Line Treatment in Metastatic Colorectal Cancer: The Role of the Oxaliplatin-Free Interval. (PubMed, Cancers (Basel)) - "All patients had received first-line FOLFOX plus cetuximab or panitumumab, followed by FOLFIRI plus bevacizumab after progression...OFI was associated with PFS in a nonlinear manner, but there was no robust evidence that it modified the relative treatment effect across its continuous range. Exploratory subgroup findings based on a 6-month cutoff require external validation."

Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study. (PubMed, J Clin Oncol) - "The ERMES study did not demonstrate noninferiority of maintenance with Cet alone. Despite a more favorable safety profile, maintenance with single-agent Cet after induction with FOLFIRI/Cet cannot be recommended for all patients but could represent an option in selected cases."

Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

SU2C ACT3: Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

BREAKWATER safety lead-in (SLI): Encorafenib (E) + cetuximab (C) + chemotherapy for BRAFV600E metastatic colorectal cancer (mCRC). (ASCO-GI 2023) - P2, P3 | "In the phase 2 ANCHOR study (NCT03693170), mPFS was 5.8 mo and ORR was 48% for 1L EC + binimetinib in BRAFV600E mCRC...Pts received E 300 mg daily + C 500 mg/m2 every 2 weeks (Q2W) + either mFOLFOX6 Q2W (n=27) or FOLFIRI Q2W (n=30) in 28-day cycles until disease progression or unacceptable toxicity...Expected conclusions will be included in the final abstract. Clinical trial information: NCT04607421."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "BREAKWATER demonstrated a significantly improved response rate that was durable for first-line EC+mFOLFOX6 versus SOC in patients with BRAF V600E mCRC. ClinicalTrials.gov identifier: NCT04607421 ."

Journal • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Preliminary clinical results of QTX3034, an oral G12D-preferring KRAS inhibitor, in combination with cetuximab ± mFOLFOX6 in patients with KRASG12D-mutated colorectal cancer (CRC) (ESMO 2026) - No abstract available

Clinical • Combination therapy • Colorectal Cancer • Oncology • Solid Tumor • KRAS

KRAS Variant-Specific Chemoradiation Response and Tumor Microenvironment Characterization in Locally Advanced Rectal Cancer: An Integrated Transcriptomic Profiling (ASTRO 2026) - "Materials/ We analyzed 203 LARC patients from the GSE87211 cohort, all receiving neoadjuvant CRT (5-fluorouracil ± oxaliplatin ± cetuximab with RT). KRAS G12V was associated with complete CRT resistance (0% pCR). Tumors achieving pCR showed an immune-activated, hypoxia-low profile with upregulated CD8A/IFNG and downregulated VEGFA/SLC2A1. G12V patients may benefit from intensified TNT or immunotherapy-radiation combinations."

Biomarker • IO biomarker • Metastases • Tumor microenvironment • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • CD8 • CXCL9 • EPAS1 • IFNG • KRAS • LAG3 • SLC2A1