oxaliplatin / Generic mfg. - LARVOL DELTA

Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. (PubMed, N Engl J Med) - "A ctDNA-guided approach to the treatment of stage II colon cancer reduced adjuvant chemotherapy use without compromising recurrence-free survival. (Supported by the Australian National Health and Medical Research Council and others; DYNAMIC Australian New Zealand Clinical Trials Registry number, ACTRN12615000381583.)."

Circulating tumor DNA • Journal • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Pathological complete response (pCR) to durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric and gastroesophageal junction cancer (GC/GEJC): Interim results of the global, phase III MATTERHORN study (ESMO 2023) - P3 | "Conclusions The addition of D to perioperative FLOT therapy demonstrated a clinically meaningful and statistically significant improvement in pCR in resectable GC/GEJC, with a tolerable safety profile. The MATTERHORN study is ongoing for the primary endpoint of event-free survival."

Clinical • Late-breaking abstract • P3 data • P3 data: top line • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. (PubMed, Lancet) - P3 | "Glofit-GemOx had a significant overall survival benefit compared with R-GemOx, supporting its use in transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma after one or more previous lines of therapy."

Clinical • Journal • P3 data • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Phase II trial of organ preservation program using short-course radiation and FOLFOXIRI for rectal cancer (SHORT-FOX): Two-Year primary outcome analysis. (PubMed, Radiother Oncol) - "Short-course radiotherapy with a boost followed by FOLFIXIRI results in OP in one-quarter of patients with high-risk rectal cancer, with poorer response among younger patients and T4 disease. Mid-treatment response may help guide timely decision-making regarding treatment."

Journal • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • 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

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

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

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

Prognostic Indicators of Preoperative Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel Efficacy in Locally Advanced Gastroesophageal and Gastric Cancer: Integrating Biomarker Analysis and Clinicopathological Factors. (PubMed, JCO Precis Oncol) - "HER2, PD-L1, and CLDN18.2 statuses were not linked to pathological response to FLOT in resectable GC/GEJC. CLDN18.2 expression significantly decreased after preoperative FLOT but remained higher in patients without MPR, suggesting that CLDN18.2-targeted therapy may warrant investigation in the perioperative setting."

Biomarker • IO biomarker • Journal • Observational data • Retrospective data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

Efficacy and safety of neoadjuvant toripalimab plus chemotherapy in localized deficient mismatch repair/microsatellite instability-high gastric or esophagogastric junction adenocarcinoma (NICE): a multicentre, single-arm, exploratory phase 2 study. (PubMed, EClinicalMedicine) - P2 | "Patients received four cycles of neoadjuvant toripalimab (240 mg IV every 3 weeks) plus CapeOX (capecitabine 1000 mg/m2 orally twice daily on Days 1-14 and oxaliplatin 130 mg/m2 IV on Day 1), followed by curative-intent surgery and up to four cycles of the same regimen as adjuvant therapy. Nonetheless, neoadjuvant toripalimab combined with the CapeOX regimen is feasible for localized advanced dMMR/MSI-H GC/EGJC, demonstrating high MPR and pCR rates without unexpected adverse events. Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Hospitals Authority Clinical Medicine Development, Beijing Natural Science Foundation, Key Clinical Technique of Guangzhou, Key Areas Research and Development Programs of Guangdong Province, National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, Clinical Research Program of Nanfang Hospital."

dMMR • IO biomarker • Journal • Mismatch repair • MSI-H • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Infectious Disease • Microsatellite Instability • Novel Coronavirus Disease • Oncology • Solid Tumor • MSI

Neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy in resectable and borderline resectable pancreatic cancer (PREOPANC-2): a multicentre, open-label, phase 3 randomised trial. (PubMed, Lancet Oncol) - P3 | "This randomised trial did not show a difference in overall survival between neoadjuvant FOLFIRINOX and neoadjuvant gemcitabine-based chemoradiotherapy in patients with resectable or borderline resectable PDAC. Both neoadjuvant treatment regimens may be considered in these patients."

Journal • P3 data • Hematological Disorders • Leukopenia • Mucositis • Neutropenia • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

PASS-01: Randomized Phase II Trial of Modified FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel and Molecular Correlatives for Previously Untreated Metastatic Pancreatic Cancer. (PubMed, J Clin Oncol) - "In the phase II Pancreatic Adenocarcinoma Signature Stratification for Treatment-01 (PASS-01) trial population, PFS was similar between GnP and mFFX; however, OS and safety trends favored GnP. The second-line setting appears inadequate to offer precision choices, given the short survival observed."

Journal • P2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRCA1 • BRCA2 • PALB2

ctDNA-guided adjuvant chemotherapy de-escalation in stage III colon cancer: Primary analysis of the ctDNA-negative cohort from the randomized AGITG DYNAMIC-III trial (Intergroup study of AGITG and CCTG) (ESMO 2025) - P2/3 | "Conclusions Stage III colon cancer pts with negative post-surgery ctDNA had low recurrence risk. ctDNA-guided de-escalation is feasible, substantially reduces oxaliplatin exposure and adverse events, with outcomes approaching standard management, especially for clinical low-risk tumours."

Circulating tumor DNA • Clinical • Late-breaking abstract • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Pembrolizumab and trastuzumab in combination with FLOT in the perioperative treatment of HER2-positive localized esophagogastric adenocarcinoma: Interim analysis of the phase II PHERFLOT/IKF-053 trial of the AIO study group (AIO STO 0321) (ESMO 2025) - P2 | "Perioperatively, FLOT (5-FU, leucovorin, oxaliplatin, docetaxel) is preferred in resectable HER2-positive disease...All pts experienced adverse events (AEs); 48.4% had at least one grade 3 treatment-related (TR) serious AE, predominantly chemotherapy-related; grade 4 neutropenia was the only ≥ grade 4 TRAE. Table: 2095MO Pathological response n (%) Missing value due to withdrawal from surgery 1 (3.2%) Complete Response (pCR) - no tumor cells visible, but signs of regression 15 (48.4%) Subtotal Response (pSR) - morphologically intact neoplastic cells in 50% of tumor bed 6 (19.4%) Conclusions Perioperative FLOT plus P and T is feasible, with an expected safety profile and strong antitumor activity, suggesting superiority over current standards."

Combination therapy • IO biomarker • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Results of a randomized phase III trial of short-course versus long-course pre-operative chemotherapy for stage I-III pancreatic ductal adenocarcinoma (PDAC) (ESMO 2025) - P2, P3 | "Methods CASSANDRA (NCT04793932) phase 3 trial, conducted by Associazione Italiana Studio Pancreas, enrolled patients (pts) ≤75y with R/BR PDAC, stratified by site and CA19-9, who were randomized to either PAXG (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) or mFOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, oxaliplatin). EFS was not significantly prolonged. However, data suggests that longer duration may be preferable."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9

Fruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase Ib/II study (ESMO 2025) - P1/2 | "Methods Adults with MSS mCRC who had progressed on or had intolerance to ≥2 lines of chemotherapy (including fluorouracil, oxaliplatin, and irinotecan) and previous VEGF/EGFR inhibitors as indicated, were enrolled. Conclusions Fruquintinib + tislelizumab showed efficacy and tolerability in pts with previously treated mCRC; efficacy outcomes were more favorable in pts without liver mets at BL, with a notable improvement in median PFS. Safety data were consistent with known profiles of both treatments."

Metastases • P1/2 data • Colorectal Cancer • Oncology • Solid Tumor

Circulating tumour (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER (ESMO 2025) - P3 | "Background The randomized phase III BREAKWATER study (NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR with encorafenib + cetuximab (EC) + mFOLFOX6 vs chemotherapy ± bevacizumab (control) in 1L BRAF V600E-mutant mCRC (Kopetz et al 2025)...Table: 729MO BRAF V600E VAF-high at BL BRAF V600E VAF-low at BL EC (n=61) EC + mFOLFOX6 (n=95) Control (n=91) EC (n=62) EC + mFOLFOX6 (n=96) Control (n=89) ORR, % (95% CI) 49 (36, 62) 75 (65, 83) 42 (32, 53) 40 (28, 54) 63 (52, 72) 40 (30, 51) OS HR (95% CI) 0.76 (0.52, 1.13) 0.50 (0.35, 0.73) – 0.66 (0.41, 1.06) 0.39 (0.24, 0.64) – ORR, objective response rate; OS, overall survival. Conclusions Clinical benefit across BRAF V600E subgroups and differential patterns of acquired resistance mutations support EC+mFOLFOX6 as a SOC for pts with BRAF V600E-mutant mCRC."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS • MAP2K1 • NRAS

Subsequent therapies in the phase III BREAKWATER study of first-line encorafenib + cetuximab + mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer (ESMO 2025) - P3 | "Background BREAKWATER (NCT04607421) is an ongoing, open-label, global, randomized, phase III study evaluating first-line (1L) encorafenib + cetuximab (EC) ± mFOLFOX6 vs chemotherapy ± bevacizumab (control) in BRAF V600E-mutant metastatic colorectal cancer (mCRC)...Table: 751P Patients, n (%) EC n=158 EC+mFOLFOX6 n=236 Control n=243 Discontinued study treatment 146 (92.4) 169 (71.6) 227 (93.4) Any subsequent systemic anticancer treatment 107 (67.7) 108 (45.8) 139 (57.2) BRAF inhibitor ± combination 21 (13.3) 19 (8.1) 100 (41.2) EC ± combination 14 (8.9) 15 (6.4) 77 (31.7) EC 4 (2.5) 9 (3.8) 62 (25.5) EP ± combination 0 1 (0.4) 4 (1.6) EP 0 0 4 (1.6) First subsequent BRAF inhibitor ± combination 2L 8 (5.1) 10 (4.2) 83 (34.2) 3L 8 (5.1) 8 (3.4) 14 (5.8) 4L 4 (2.5) 0 2 (0.8) 5L 1 (0.6) 1 (0.4) 1 (0.4) BRAF inhibitor ± combination in >1 subsequent line 3 (1.9) 3 (1.3) 6 (2.5) EP, encorafenib + panitumumab...Of these, most received..."

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

Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO (ASH 2025) - P3 | "We report updated efficacy and safety of Glofit-GemOxversus R-GemOx, with 3 years of follow-up, in patients with R/R DLBCL after ≥1 prior line of therapy (LOT)from the global Phase III STARGLO trial (NCT04408638).MethodsPatients were randomized 2:1 to either Glofit-GemOx (8 cycles plus 4 cycles glofitamab monotherapy) orR-GemOx (8 cycles) and stratified by number of prior LOT (1 vs ≥2) and refractoriness to last therapy.Following obinutuzumab pretreatment, glofitamab was given in Cycle 1 as weekly step-up doses(2.5/10mg), then 30mg target dose every 21 days from Cycle 2 Day 1. The safety profile remained consistent with the known risks of each study drug and wasmanageable. This updated analysis demonstrates the sustained remission and continued survivaladvantages that fixed-duration Glofit-GemOx offers for patients with R/R DLBCL."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease

Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Observational studies have associated use of aspirin and selective cyclooxygenase inhibitors with decreased recurrence and improved survival in patients with colon cancer...This was a post hoc analysis of the phase 3 Cancer and Leukemia Group B (now Alliance)/Southwest Oncology Group 80702 randomized clinical trial (2010-2015) assessing adjuvant celecoxib vs placebo and 3 vs 6 months of adjuvant 5-fluorouracil, leucovorin, and oxaliplatin for stage III colon cancer...The findings of this post hoc analysis suggest that ctDNA status has the potential to inform clinical decision-making among patients with stage III colon cancer who should consider adjuvant celecoxib in addition to conventional chemotherapy. ClinicalTrials.gov Identifier: NCT01150045."

Circulating tumor DNA • Clinical • Journal • P3 data • Retrospective data • Colon Cancer • Colorectal Cancer • Hematological Malignancies • Leukemia • Microsatellite Instability • Oncology • Solid Tumor • MSI • PIK3CA

Colorectal Cancer Metastatic dMMR Immunotherapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo (FFX/bev) in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC)— NRG-GI004/SWOG-S1610. (ASCO-GI 2026) - P3 | "Background: Immunotherapy for frontline dMMR/MSI-H mCRC is highly effective, however, nearly half of pts treated with pembrolizumab monotherapy in the KEYNOTE 177 trial progressed within 12 months... The combination of FFX/bev+atezo led to significantly longer PFS than atezo monotherapy in the first-line setting for dMMR mCRC. *Drs. Rocha Lima and Overman contributed equally."

Clinical • dMMR • IO biomarker • Metastases • Mismatch repair • Monotherapy • MSI-H • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

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

Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. (ASCO-GI 2026) - P2, P3 | "Zolbetuximab + mFOLFOX6 and nivolumab showed promising activity in patients with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma, particularly in those with high CLDN18.2 expression. AEs were consistent with the safety profile of zolbetuximab + chemotherapy. The ongoing phase 3 LUCERNA trial (NCT06901531) is assessing 1L zolbetuximab + pembrolizumab and chemotherapy in patients with HER2−, LA unresectable or mG/GEJ adenocarcinoma with CLDN18.2+ and PD-L1+ tumors."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

CRITICS-II: A multicenter randomized phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. (ASCO-GI 2026) - P2 | " In this multicenter phase II study, patients with clinical stage IB-IIIC (TNM8) resectable gastric adenocarcinoma were randomized between: (arm 1) 4 cycles docetaxel+oxaliplatin+capecitabine (DOC), (arm 2) 2 cycles DOC followed by chemoradiotherapy (45Gy/25 fractions + weekly paclitaxel/carboplatin) or (arm 3) chemoradiotherapy. Preoperative chemotherapy alone failed the EFS threshold, showed lowest survival and high toxicity, and was excluded from further evaluation. Both arm 2 and 3 were sufficiently active; survival favored arm 2, toxicity/compliance favored arm 3. Considering postoperative complications and pathological response rates, arm 2 ("total neoadjuvant" chemotherapy + chemoradiotherapy) emerged as the preferred candidate for further study, especially in the context of organ sparing approaches."

Clinical • P2 data • Surgery • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor