capecitabine / Generic mfg. - LARVOL DELTA

Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma (ESMO 2024) - P3 | "We present results of the final analysis of OS for KEYNOTE-811. Eligible patients (pts) aged ≥18 years with treatment-naive unresectable, HER2+ mG/GEJ adenocarcinoma irrespective of PD-L1 status were randomized 1:1 to pembro 200 mg IV Q3W or pbo IV Q3W plus chemo (5-FU and cisplatin [FP] or capecitabine and oxaliplatin [CAPOX] and trastuzumab [SOC])... First-line pembro plus trastuzumab and chemo provided a statistically significant and clinically meaningful improvement in OS vs pbo plus trastuzumab and chemo in all pts with unresectable, HER2+ mG/GEJ cancer. OS was longer in pts with PD-L1 CPS ≥1. These data support the approval of pembro plus trastuzumab and chemo in pts with HER2+ mG/GEJ cancer and confirm this regimen as SOC in the first-line setting."

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

Pancreatic Adenocarcinoma: Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 Phase III Trial. (PubMed, J Clin Oncol) - "GemCap is a standard option for patients not eligible for mFOLFIRINOX. Exploratory evidence suggests that GemCap may be particularly efficacious in R0 patients and also in lymph node-negative patients."

Journal • P3 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Anlotinib versus bevacizumab added to standard first-line chemotherapy among patients with RAS/BRAF wild-type, unresectable metastatic colorectal cancer: A multicenter, prospective, randomised, phase 3 clinical trial (ANCHOR trial). (ASCO 2025) - P3 | " In this Chinese multicenter, randomised, non-inferiority, phase 3 trial, treatment-naïve RAS/BRAF wild-type mCRC patients with MDT-assessed unresectable metastases were 1:1 randomised to receive anlotinib (12mg, QD, days 1-14) or bevacizumab (7.5mg/kg, IV, day 1), both combined with oxaliplatin (130mg/m², IV, day 1) and capecitabine (anlotinib group:850mg/m2, bevacizumab group 1000mg/m², BID, days 1-14) in 3-week cycles. In unresectable RAS/BRAF wild-type mCRC patients, anlotinib plus CapeOX showed comparable PFS time and safety compared with bevacizumab plus CapeOX. The results provide a new treatment option for unresectable RAS/BRAF wild-type mCRC patients."

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

Zanidatamab (Zani) + chemotherapy (Chemo) for patients (Pts) with HER2-expressing metastatic breast cancer (mBC): Final results of a phase I trial (ESMO-BC 2025) - P1 | "We report the final analysis of a phase I trial of zani + chemo in pts with HER2-expressing mBC. Part 3 of the phase I trial (NCT02892123) evaluated zani + chemo (paclitaxel [pac], capecitabine [cap] or vinorelbine [vin]) or zani + cap + tucatinib (tuc) in pts with HER2-expressing mBC...Prior (>5% of pts) anti-HER2 therapies included trastuzumab (93%), T-DM1 (91%), pertuzumab (80%), lapatinib (24%), T-DXd (9%), tuc (9%), and neratinib (7%)... Zani + chemo had a manageable safety profile and good tolerability with promising antitumour activity and durable responses in heavily pretreated pts with HER2-expressing mBC. Among pts with HER2+ mBC with prior HER2-targeted regimens, adding zani to chemo showed encouraging PFS."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study. (ASCO 2025) - P2 | " Eligible pts with R/M NPC had failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor, and were randomized to receive MRG003 (2.3 mg/kg, d1, iv, Q3W) or chemotherapy (capecitabine 1000 mg/m2, po, twice daily, d1-14, Q3W; or docetaxel 75 mg/m2, iv, d1, Q3W). As the first ADC clinical study targeting heavily pretreated R/M NPC, becotatug vedotin demonstrated statistically and clinically meaningful benefits while maintaining a manageable safety profile in this population. This study will lead to a paradigm shift in the treatment of R/M NPC. Sponsor: Lepu Biopharma Co., Ltd."

Clinical • Late-breaking abstract • Metastases • Nasopharyngeal Carcinoma • 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

Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "The observed camrelizumab plus concurrent capecitabine and radiotherapy efficacy warrants further study with active treatment (chemotherapy or chemoradiation therapy) as the control group. ClinicalTrials.gov Identifier: NCT04333927."

Clinical • Journal • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Implementation of DPYD and UGT1A1 Testing in Patients With GI Cancer: A Prospective, Nonrandomized Clinical Trial. (PubMed, JCO Precis Oncol) - "Pretreatment DPYD/UGT1A1 testing and dose reduction was feasible, enabling clinicians to make the appropriate chemotherapy dose reductions, reducing occurrence of adverse outcomes. DPYD/UGT1A1 testing is an important precision oncology approach to optimize patient safety."

Clinical • Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • DPYD • UGT1A1

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

FOXC1 expression predicts capecitabine efficacy in triple-negative breast cancer patients from the GEICAM_CIBOMA trial. (PubMed, Clin Cancer Res) - P3 | "This ambispective GEICAM_CIBOMA translational analysis validated FOXC1-based basal-like/non-basal subtyping as a pragmatic alternative to PAM50 subtyping and independently predicted the benefit of adding capecitabine to standard (neo)adjuvant chemotherapy in TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FOXC1

Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Final results of the phase III COMPASSION-15 trial (ESMO 2025) - P3 | "Pts were randomized 1:1 to receive Cado (10mg/kg Q3W) or placebo plus chemo (XELOX Q3W)...These authors contributed equally: Lin Shen, Yanqiao Zhang, Ziyu Li, Xiaotian Zhang. Lin Shen and Jiafu Ji are the corresponding authors."

Clinical • IO biomarker • Metastases • P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CTLA4 • HER-2 • PD-1 • 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

SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01) (ESMO 2025) - P3 | "Methods Taxane- and trastuzumab-pretreated patients (pts) with HER2+ advanced/metastatic BC were randomized (1:1) to receive intravenous SHR-A1811 or oral pyrotinib plus capecitabine...Results As of Jun 30, 2025, 287 pts were randomized (SHR-A1811, n=142; pyrotinib plus capecitabine, n=145; IHC 3+: 76.1% vs. 71.7%; HR+: 47.9% vs. 47.6%; median lines of prior systemic treatments: 1 vs.1; prior pertuzumab: 71.8% vs. 72.4%), with median follow-up of 15.9 months (95% CI 14.6–17.1) for SHR-A1811, and 15.3 months (95% CI 14.3–16.6) for pyrotinib plus capecitabine...b 1-sided c. assessed in treated pts. Conclusions SHR-A1811 exhibited significant PFS benefit and strong trend in OS benefit versus pyrotinib plus capecitabine in the second-line therapy in HER2+ advanced/metastatic BC, with favorable safety profile of low ILD occurrence."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant toripalimab plus lenvatinib and GEMOX in resectable, high-risk intrahepatic cholangiocarcinoma: A randomized, multicenter, open-label phase II-III clinical trial (ESMO 2025) - P2/3 | "All pts received adjuvant capecitabine Q3W for 8 cycles after curative resection. During neoadjuvant therapy, all-grade treatment-related adverse events (TRAEs) occurred in 92% of pts (grade ≥3: 26.4%). Table: LBA11 Efficacy summary Neo arm (n=88) Ctrl arm (n=90) Median EFS, mo 18.0 8.7 HR 0.48 (95% CI 0.31-0.74; p=0.0006) Median OS, mo NR 31.4 HR 0.43 (95% CI 0.23-0.79; p=0.0050) Median RFS, mo 15.4 9.7 HR 0.69 (95% CI 0.45-1.06) ORR, n (%) 48 (54.5) - MPR, n (%) 17 (19.3) 0 pCR, n (%) 4 (4.5) 0 R0 resection rate, n (%) 84 (95.5) 84 (93.3) Conclusions For resectable high-risk iCCAs, neoadjuvant GOLP regimen demonstrated statistically significant improvement in EFS compared with traditional resection, with manageable safety."

Clinical • Late-breaking abstract • P2/3 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology

First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial (ESMO 2025) - P1, P3 | "Methods Adult pts with previously untreated locally recurrent inoperable or mTNBC, for whom immunotherapy was not an option, were randomised 1:1 to Dato-DXd (6 mg/kg IV Q3W) or investigator's choice of chemotherapy (ICC; [nab]-paclitaxel/ capecitabine/ eribulin mesylate/ carboplatin). The Dato-DXd safety profile was manageable. Results support Dato-DXd as the new 1L standard of care."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Factors influencing locoregional recurrence rates in locally advanced rectal cancer after total neoadjuvant treatment versus chemoradiotherapy in the RAPIDO trial. (PubMed, Br J Surg) - "The difference in LRR between TNT and CRT mainly occurred in patients treated with sphincter-preserving surgery. Baseline information on the original tumour bed should be considered when determining the surgical approach after total neoadjuvant treatment."

Clinical • Journal • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Concurrent chemoradiotherapy with/without adjuvant capecitabine in locoregionally advanced nasopharyngeal carcinoma: A randomized controlled phase III trial (ESMO 2025) - P3 | "All patients were randomly assigned in a 1:1 ratio to receive CCRT (3-weekly cisplatin at 100 mg/m 2 for 2-3 cycles) followed by AC (1000 mg/m 2 bi-daily for 14 days every 21-day cycle for 8 cycles), or CCRT alone. The most common ≥grade 1 toxicities relating capecitabine included anemia (60.1%), leukopenia (47.6%), and hand-foot syndrome (44.1%); and the most common grade 3-4 toxicities relating capecitabine included neutropenia (3.5%), hand-foot syndrome (2.8%), and leukopenia (1.4%). Conclusions Adding adjuvant capecitabine after CCRT conferred superior survivals than CCRT alone in LANPC patients, with mild toxicities."

Clinical • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Trifluridine/tipiracil in combination with capecitabine and bevacizumab as upfront treatment for metastatic colorectal cancer: first results of the phase II TriComB study by GONO (ESMO 2025) - P1/2 | "Conclusions TRICOMB met its primary endpoint. The sequential combination of CAP, FTD/TPI, and BEV, according to the TRICOMB regimen, deserves further investigation as upfront therapy of mCRC."

Combination therapy • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07 (SABCS 2025) - P3 | " Participants were randomized 2:1 to receive SG 10 mg/kg IV or chemotherapy treatment of physician's choice (TPC; capecitabine, nab-paclitaxel, or paclitaxel). The study did not meet the primary endpoint of PFS by BICR in participants with HR+/HER2−, locally advanced unresectable or mBC who have received prior ET and are candidates for first chemotherapy. No new safety concerns were identified. An early trend in improvement of OS was observed, and the study will continue to further assess OS."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Total neoadjuvant therapy followed by non-operative management or surgery in stage II-III rectal cancer (NO-CUT): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "In pMMR/MSS stage II-III rectal cancer, total neoadjuvant therapy followed by non-operative management allows organ preservation in some patients without compromising distant relapse-free survival, supporting non-operative management as a treatment option in clinical practice."

Journal • P2 data • Colorectal Cancer • Hematological Disorders • Neutropenia • Oncology • Rectal Cancer • Solid Tumor

Tumor infiltrating lymphocytes in post-NACT residual tumors in ECOG-ACRIN EA1131 - impact of intrinsic subtypes. (SABCS 2025) - "Patients and EA1131 enrolled patients with clinical stage II or III TNBC with ≥1.0 cm residual disease (RD) in the breast post-NAC were randomly assigned to receive platinum (carboplatin or cisplatin) once every 3 weeks for four cycles or capecitabine on days 1-14 of a 21-day cycle for six cycles. In the EA1131 clinical trial, patients with residual basal-like TNBC and low sTILs had the worse iDFS, delineating a particularly high-risk subgroup. These findings underscore the prognostic relevance of post-treatment immune microenvironment characteristics and suggest that patients with basal-like, TIL-low residual TNBC may derive limited benefit from current standard adjuvant therapies. Further investigation is warranted to identify and develop tailored therapeutic approaches for this biologically aggressive subgroup to improve long-term outcomes."

Tumor-infiltrating lymphocyte • Breast Cancer • Oncology • Triple Negative Breast Cancer

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

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

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

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