5-fluorouracil / Generic mfg. - LARVOL DELTA

Comprehensive genomic profiling by liquid biopsy portrays metastatic colorectal cancer mutational landscape to predict antitumor efficacy of FOLFIRI plus cetuximab in the CAPRI-2 GOIM trial. (PubMed, ESMO Open) - "These results support the integration of LBx-CGP for implementing the efficacy and for optimizing the use of anti-EGFR therapies in RAS/BRAF WT mCRC."

Journal • Liquid biopsy • Colorectal Cancer • Oncology • Solid Tumor • ALK • BRAF • FGFR • HER-2 • MAP2K1 • NF1 • NTRK • PIK3CA • ROS1

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). (ASCO 2025) - P3 | "The phase III ATOMIC trial (NCT02912559) was conducted to determine whether atezolizumab (atezo), an anti-PD-L1 antibody, can improve pt outcomes when added to adjuvant 5-fluorouracil, leucovorin plus oxaliplatin (mFOLFOX6) in pts with stage III dMMR tumors. The addition of atezolizumab to mFOLFOX6 significantly improved DFS and should be considered the new adjuvant standard of care for patients with dMMR stage III colon cancer. Support: U10CA180821, U10CA180882, U24CA196171; Genentech, a member of the Roche group; https://acknowledgments.alliancefound.org."

Clinical • dMMR • Late-breaking abstract • Mismatch repair • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Pediatrics • Solid Tumor

Event-free survival (EFS) in MATTERHORN: A randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC). (ASCO 2025) - P3 | "D + FLOT demonstrated a statistically significant improvement in EFS vs P + FLOT in pts with resectable GC/GEJC, with an encouraging OS trend. These results support D + FLOT as a potential new global SoC for resectable GC/GEJC."

Clinical • Late-breaking abstract • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Recurrence patterns in the prospective, randomized, controlled, multicenter phase III ESOPEC trial comparing perioperative chemotherapy with preoperative chemoradiotherapy in patients with esophageal adenocarcinoma. (ASCO 2025) - P3 | " Pts with cT1 cN+ cM0 or cT2-4a cNany cM0 EAC undergoing preoperative chemotherapy with FLOT (5-FU/leucovorin/oxaliplatin/docetaxel) or preoperative chemoradiotherapy with CROSS (41.4Gy/carboplatin/paclitaxel) plus tumor resection from the ESOPEC trial were eligible... Perioperative chemotherapy with FLOT improves RFS and DMFS compared to preoperative chemoradiotherapy with CROSS in EAC. The prognosis of pts is determined by distant recurrence, which is less common after FLOT than CROSS. Treatment group comparisons regarding site of recurrence.* % calculated as 3-year cumulative incidence"

Clinical • P3 data • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): Progression-free survival and updated overall survival analyses. (ASCO 2025) - P3 | "Funded by Pfizer Clinical Trial Registration Number: NCT04607421 Background: BREAKWATER (NCT04607421) is an open-label, global, randomized, phase 3 study evaluating first-line (1L) encorafenib + cetuximab (EC) ± chemotherapy (chemo) vs standard of care (SOC; chemo ± bevacizumab) in BRAF V600E-mutant metastatic colorectal cancer (mCRC)... BREAKWATER demonstrated clinically meaningful and statistically significant PFS and OS improvements with EC+mFOLFOX6 vs SOC and manageable toxicities. EC+mFOLFOX6 is potentially practice changing as the new SOC. a1-sided stratified log rank test."

Clinical • Late-breaking abstract • Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF

ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). (ASCO 2025) - P2/3 | "In this first randomised study of ctDNA-informed management in stage III CC, we confirm the prognostic significance of detectable ctDNA, with the novel finding of recurrence risk increasing markedly with ctDNA burden. Treatment escalation, including to FOLFOXIRI, did not improve RFS. Future studies in ctDNA positive pts should explore other escalation strategies."

Circulating tumor DNA • Clinical • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

PRODIGE 29-UCGI 26 (NEOPAN): A Phase III Randomized Trial Comparing Chemotherapy With FOLFIRINOX or Gemcitabine in Locally Advanced Pancreatic Carcinoma. (PubMed, J Clin Oncol) - "Results confirm that FOLFIRINOX improves PFS significantly compared with gemcitabine and is well tolerated in LAPC. No significant difference in OS was observed between both groups."

Journal • P3 data • Oncology • Pancreatic Cancer • Solid Tumor

Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer. (PubMed, N Engl J Med) - P3 | "This trial showed significantly longer progression-free survival and overall survival with first-line treatment with EC+mFOLFOX6 than with standard care among patients with BRAF V600E-mutated metastatic colorectal cancer. (Funded by Pfizer and others; BREAKWATER ClinicalTrials.gov number, NCT04607421.)."

Journal • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. (PubMed, N Engl J Med) - P3 | "Perioperative durvalumab plus FLOT led to significantly better event-free survival outcomes than FLOT alone among participants with resectable gastric or gastroesophageal junction adenocarcinoma. (Funded by AstraZeneca; MATTERHORN ClinicalTrials.gov number, NCT04592913.)."

Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: primary results of a multicentre, single-arm, phase 2 study. (PubMed, Lancet Oncol) - P2 | "Zanidatamab plus chemotherapy as first-line treatment of HER2-positive advanced gastro-oesophageal adenocarcinoma demonstrated clinically meaningful and durable antitumour activity, with a manageable safety profile."

Journal • P2 data • Acute Kidney Injury • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor • HER-2

Whole genome and transcriptome profiling in advanced pancreatic cancer patients on the COMPASS trial. (PubMed, Nat Commun) - P | "The COMPASS trial (NCT02750657) enrolled 268 patients with advanced PDAC; patients were given either modified (m) FOLFIRINOX or Gemcitabine-nab-paclitaxel (GnP) as per physicians choice...Basal-like PDAC and patients exhibiting evidence of systemic inflammation as annotated using the Gustave Roussy Immune Score are unique poor prognostic cohorts. The latter associates with low CD8 T cell infiltration while basal-like PDAC documents an inflamed tumour microenvironment."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • HRD • KRAS

Recurrence Patterns of Esophageal Adenocarcinoma in the Phase III ESOPEC Trial Comparing Perioperative Chemotherapy With Preoperative Chemoradiotherapy. (PubMed, J Clin Oncol) - "The ESOPEC trial showed that perioperative chemotherapy with fluorouracil (FU)/leucovorin/oxaliplatin/docetaxel (FLOT) improved survival in patients with nonmetastatic esophageal adenocarcinoma compared with preoperative chemoradiotherapy with CROSS (41.4Gy/carboplatin/paclitaxel). Distant recurrence occurred in 64 FLOT versus 89 CROSS patients (3-year cumulative incidences 31.5% v 47.2%, HR, 0.59 [95% CI, 0.43 to 0.82]; P = .002). Compared with CROSS, perioperative chemotherapy with FLOT improved survival through better systemic tumor control with a reduction in distant tumor recurrences, while locoregional efficacy was similar."

Journal • P3 data • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

Phase III randomized IRIGA trial of FOLFIRINOX versus mFOLFOX6 as first-line treatment for patients with HER2-negative gastric and gastroesophageal adenocarcinoma (ESMO-GI 2025) - P2 | "FOLFIRINOX did not significantly improve PFS or OS in the overall population. However, select subgroups may benefit from triplet therapy. Intensified regimens may be justified in patients with oligometastatic disease eligible for conversion therapy, pending further validation."

Clinical • P3 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX for resectable pancreatic cancer: A randomized phase 3 trial. (PubMed, Cancer Cell) - P3 | "Patients in the neoadjuvant group received nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX before surgery and then four cycles of adjuvant therapy (preferably gemcitabine plus capecitabine), while those in the upfront surgery group underwent immediate resection followed by six cycles of adjuvant therapy...Grade ≥3 adverse events occurred in 47.6% versus 30.7% of patients. This neoadjuvant regimen improves event-free survival with manageable safety."

Journal • P3 data • Oncology • Pancreatic Cancer • Solid Tumor

Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric / gastroesophageal junction (G / GEJ) adenocarcinoma (ESMO 2025) - P3 | "Conclusions A statistically significant and clinically meaningful improvement in OS was seen with D + FLOT vs P + FLOT, and OS also improved irrespective of PD-L1 status. EFS was improved with D + FLOT vs P + FLOT in pts with any degree of pR and regardless of ypN status."

Clinical • Late-breaking abstract • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • PD-L1

Phase I basket study of telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein-targeting antibody-drug conjugate: Results from patients (pts) with pancreatic ductal adenocarcinoma (PDAC) (ESMO 2025) - P1 | "Table: 2214MO Outcome Overall (N=42 ‡ ) 1L FOLFIRINOX (n=26) 1L gem– nab -paclitaxel (n=15) Best overall response,* ,† n (%) CR 0 0 0 PR 10 (24) 4 (15) 6 (40) SD 24 (57) 17 (65) 6 (40) PD 4 (10) 2 (8) 2 (13) NE/Not assessed 4 (10) 3 (12) 1 (7) ORR,* ,† n (%) 10 (24) 4 (15) 6 (40) CBR,* ,† n (%) 34 (81) 21 (81) 12 (80) Median PFS, mo [95% CI] 5.3 [4.0, 6.8] 5.0 [3.6, 6.2] 6.8 [2.4, NE] *Confirmed responses...CBR, clinical benefit rate; CR, complete response; NE, not estimable; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease. Conclusions Temab-A had a manageable safety profile in pts with advanced PDAC and promising efficacy, especially in pts who received 1L gemcitabine– nab -paclitaxel."

Clinical • P1 data • Pan tumor • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • MET

A phase 1/2 trial of FOG-001, a first-in-class direct β-catenin:TCF4 inhibitor, preliminary safety and efficacy in patients with solid tumors bearing Wnt pathway-activating mutations (WPAM+) (AACR-NCI-EORTC 2025) - P1/2 | "When co-administered with 5-fluorouracil (5-FU), or inhibitors of VEGF or PD-1, FOG-001 showed additive to synergistic efficacy in PDX models...Pts with MSS CRC should have received prior 5-FU, oxaliplatin, and irinotecan in the metastatic setting... FOG-001 monotherapy is well tolerated with a manageable safety profile in pts with desmoid, other WPAM+ tumors and heavily pre-treated MSS CRC. Favorable PK, on-target PD effect, and encouraging anti-tumor activity demonstrate that FOG-001 is a bona fide β-catenin inhibitor with biologic and clinical impact supporting ongoing expansion in desmoid tumors, and evaluation in combination with standard chemotherapy or nivolumab in MSS CRC."

Clinical • IO biomarker • P1/2 data • Colorectal Cancer • Desmoid Tumors • Oncology • Sarcoma • Solid Tumor • CTNNB1 • TCF4

Does perioperative FLOT increase cure rates in resectable esophageal adenocarcinoma? A mixture cure model analysis. (PubMed, Br J Cancer) - P | "Cure is an informative endpoint in localised oesophageal cancer. In this registry analysis, perioperative FLOT was associated with higher cure rates than CROSS, particularly in high-risk subgroups. Exploratory findings suggest that alternative neoadjuvant strategies, such as those incorporating ICIs or FOLFOX, warrant further investigation."

Journal • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. (ASCO-GI 2026) - P3 | "Background: HERIZON-GEA-01 (NCT05152147) is a global, open-label, phase 3 trial of zanidatamab (dual HER2-targeted bispecific antibody) + CT ± tislelizumab (anti–PD-1) vs trastuzumab (tras) + CT in 1L HER2+ mGEA. Eligible patients (pts) with previously untreated HER2+ mGEA, regardless of PD-L1 status, were randomized (1:1:1) to zanidatamab (1800 mg [12 mo) vs tras + CT. Zanidatamab + tislelizumab + CT also provided a statistically significant and clinically meaningful OS benefit (mOS >26 mo). The trial is ongoing with additional OS analyses planned for zanidatamab + CT."

Clinical • Late-breaking abstract • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). (ASCO-GI 2026) - P2, P3 | "Patients will be randomly assigned 1:1 to receive IV zolbetuximab (800 mg/m2 on cycle 1 day 1 followed by 400 mg/m2 every 2 weeks or 600 mg/m2 every 3 weeks [Q3W]) + IV pembrolizumab (200 mg Q3W or 400 mg every 6 weeks) and either a capecitabine and oxaliplatin regimen (CAPOX) or a modified folinic acid, fluorouracil, and oxaliplatin regimen (mFOLFOX6) or placebo + pembrolizumab and CAPOX/mFOLFOX6 for four 42-day cycles. Enrollment is ongoing across global sites. Clinical trial information: NCT06901531."

Clinical • IO biomarker • Metastases • P3 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

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

Liposomal irinotecan, carboplatin or oxaliplatin (LyRICX) with or without nivolumab in the first-line treatment of metastatic or irresectable esophagogastric adenocarcinoma: A randomized phase 2 study. (ASCO-GI 2026) - "Until August 2022, patients were randomized (2:2:1) to one of three arms: 1) nanoliposomal irinotecan, leucovorin and fluorouracil (F-Nal-Iri); 2) capecitabine and carboplatin (CapCar); 3) capecitabine and oxaliplatin (CapOx). Relative to CapOx, CapCar and F-Nal-Iri yielded markedly lower rates of grade 2-4 neurotoxicity with similar PFS and no excess of other toxicities. Given its ease of use—no central line required—and its relatively low cost (all drugs off-patent), CapCar can be considered the most favorable first-line chemotherapy backbone."

Clinical • Late-breaking abstract • Metastases • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of ASP3082 monotherapy or in combination with mFOLFIRINOX in patients (pts) with pancreatic ductal adenocarcinoma (PDAC). (ASCO-GI 2026) - P1 | "We present results from this first-in-human study in pts with PDAC, including dose escalation and expansion, treated with ASP3082 or ASP3082 with modified folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin (mFOLFIRINOX). ASP3082 showed promising antitumor activity alone or plus mFOLFIRINOX with no new safety signals in pts with PDAC. Findings support further evaluation of ASP3082 including DOR, progression-free survival, and overall survival in pts with KRAS G12D-mutant PDAC in both 1L and later-line settings."

Clinical • Combination therapy • First-in-human • Monotherapy • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS

Three Versus 6 Months of Adjuvant Oxaliplatin-Fluoropyrimidine Chemotherapy for Colorectal Cancer: Final Results of SCOT-An International, Randomized, Phase III, Noninferiority Trial. (PubMed, J Clin Oncol) - "Patients with high-risk stage II and stage III CRC were assigned (1:1) to receive 3 or 6 months of either capecitabine and oxaliplatin (CAPOX) or infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX; bolus and infused fluorouracil with oxaliplatin) that were selected before random assignment. The duration effect is regimen-dependent with noninferiority shown for CAPOX but not for FOLFOX. In summary, SCOT has shown noninferiority for OS with 3 months of adjuvant chemotherapy treatment, which should be recommended for most patients."

Head-to-Head • Journal • P3 data • Colorectal Cancer • Oncology • Pain • Solid Tumor

BREAKWATER phase 3: Post hoc subgroup analyses by age in patients (pts) with BRAF V600E-mutant metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P3 | "BREAKWATER (Phase 3; NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR, PFS by blinded independent central review (BICR), and OS with encorafenib + cetuximab (EC)+mFOLFOX6 vs control (chemotherapy±bevacizumab) in 1L BRAF V600E-mutant mCRC, making EC+mFOLFOX6 a new standard of care... All pts with BRAF V600E-mutant mCRC receiving 1L EC+mFOLFOX6, including EOCRC pts, showed improved ORR, PFS, and OS vs control. The safety profile of EC+mFOLFOX6 was similar for both age groups. NE, not estimable."

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