sorafenib / Generic mfg. - LARVOL DELTA

Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. (PubMed, J Hepatol) - P3 | "At 5 years, STRIDE sustained an OS benefit versus sorafenib and maintained a manageable safety profile. OS benefit with STRIDE was improved in participants with disease control. Data suggest that any degree of tumour shrinkage with STRIDE can be associated with improved OS, indicating that conventional response measures may not fully capture STRIDE benefits. Nevertheless, participants experiencing deep responses appear to have the greatest benefit. STRIDE continues to set new benchmarks in uHCC with 1 in 5 patients alive at 5 years."

Journal • Hepatocellular Cancer • Oncology

Outcomes by liver function in patients with unresectable hepatocellular carcinoma treated with nivolumab plus ipilimumab vs lenvatinib or sorafenib in the CheckMate 9DW trial (EASL 2025) - "NIVO + IPI showed a favorable benefit-risk profile vs LEN/SOR across ALBI subgroups. These results support NIVO + IPI as a potential 1L treatment option for pts with uHCC, regardless of liver function."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Anlotinib plus penpulimab significantly improved progression-free survival and overall survival versus sorafenib in unresectable HCC and might be a new first-line option. These findings require verification in other regions of the world."

Journal • P3 data • Cardiovascular • Hepatocellular Cancer • Hepatology • Hypertension • Liver Failure • Oncology • Solid Tumor • AFP

Evaluation of hyperprogressive disease with atezolizumab plus bevacizumab for hepatocellular carcinoma: A secondary analysis of the IMbrave150 trial. (PubMed, Int J Cancer) - "For all definitions of early progression/treatment failure, the risk was either significantly lower with atezolizumab plus bevacizumab than with sorafenib, or there were no differences. Atezolizumab plus bevacizumab treatment is unlikely to cause significant HPD."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • AFP

Toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HEPATORCH): a randomised, open-label, phase 3 trial. (PubMed, Lancet Gastroenterol Hepatol) - P3 | "Among patients with previously untreated advanced hepatocellular carcinoma, toripalimab plus bevacizumab resulted in significantly longer progression-free survival and overall survival than did sorafenib, with an acceptable safety profile. Based on these results, the regimen has been approved for use in China by the National Medical Products Administration."

Journal • P3 data • Cardiovascular • Hematological Disorders • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • Thrombocytopenia

IKF-035/ABC-HCC: A phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma (ESMO 2025) - P3 | "The IMbrave150 phase 3 study showed that the combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF antibody bevacizumab (atezo/bev) extend survival compared to sorafenib in 1L treatment of advanced and intermediate HCC failing/unsuited for TACE. Conclusions The first IA provides important insights into the efficacy of atezo/bev vs. TACE in intermediate stage HCC. Based on these findings, the trial is progressing to the 2nd IA at 66% information time (169 events)."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

IKF-035/ABC-HCC: A phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma. (ASCO-GI 2026) - "The IMbrave150 phase 3 study demonstrated that combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF antibody bevacizumab (atezo/bev) extends survival compared to sorafenib in first-line treatment of advanced and intermediate stage HCC failing/unsuited for TACE which has led to its approval in this setting. The results of the first IA provide important insights into the efficacy of atezo/bev vs. TACE in intermediate stage HCC and suggest a superiority of systemic therapy compared to TACE in regard to TTFS. Based on these findings, the trial is progressing to the second IA at 66% information time (169 events)."

Clinical • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Nivolumab plus ipilimumab vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (HCC): 4-year follow-up of CheckMate 9DW. (ASCO-GI 2026) - P3 | "After 4 years of follow-up, 1L NIVO + IPI continued to show sustained efficacy benefit vs LEN/SOR in unresectable HCC and manageable safety with no new concerns. These results continue to support NIVO + IPI as a standard-of-care treatment in these patients. aPer BICR."

Clinical • Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma: A cost-effectiveness analysis. (PubMed, Cancer) - "Nivolumab plus ipilimumab is unlikely to be cost-effective as first-line therapy for unresectable HCC from US health care payer perspective. However, extended dosing interval or price reductions may render the regimen economically viable, with important implications for clinical practice, payers, and policy."

Clinical • HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Structure-Guided Design of Benzothiazole and Benzimidazole-Based Urea Derivatives Curtailing Oncogenic Signaling via Concurrent Inhibition of VEGFR-2, EGFR, and c‑Met. (PubMed, ACS Omega) - "The 200 ns molecular dynamics (MD) simulations confirmed the stability of the 4ASD-6b complex with enhanced flexibility compared to sorafenib. Collectively, these findings establish benzothiazole, benzimidazole, and quinoline-based urea hybrids as promising leads with enhanced multikinase selectivity and reduced toxicity compared to existing inhibitors, offering strong therapeutic potential in angiogenesis-driven cancers."

Journal • Oncology • EGFR • KDR • MET

Prediction of Prognosis, Tumor Microenvironment, and Drug Treatment of Colorectal Cancer Based on Retinoic Acid-Related Genes. (PubMed, J Environ Pathol Toxicol Oncol) - "Drug sensitivity prediction results revealed that AZ628, CGP-082996, CKM, Dasatinib, GNF-2, Saracatinib, Sorafenib, WH-4-023, and WZ-1-84 were more sensitive for patients in the HR group. AKT inhibitor VIII, Gemcitabine, JW-7-52-1, Mitomycin, NSC-87877, PAC-1, Pyrimethamine, QS11, and Roscovitine were more sensitive for those in the LR group. Our project identified correlations between RA-related genes and CRC. The model genes identified are essential indicators for evaluating CRC prognosis and further treating CRC."

Biomarker • Journal • Colorectal Cancer • Oncology • Solid Tumor

MAINTENANCE THERAPY POST HEMATOPOIETIC STEM CELL TRANSPLANT IN ACUTE MYELOID LEUKEMIA WITH FLT3 INHIBITORS AND HYPOMETHYLATING AGENTS: INSIGHTS FROM THE EBMT ACUTE LEUKEMIA WORKING PARTY (EBMT 2026) - " 317 patients identified, 171 received prophylaxis with FLT3i (58% Sorafenib, 30% midostaurin, 11% gilteritinib; 3 patients received sorafenib and midostaurin); while 146 patients received HMA (135 azacitidine/11 decitabine)...Patient characteristics for both groups (FLT3i and HMA)Abbreviations: AML: acute myeloid leukemia; ELN: European LeukemiaNet; GVHD: graft versus host disease; HSCT: allogeneic hematopoietic stem cell transplant; IQR: interquartile range; MRD: minimal residual diseaseGraph 1. This real-world data reinforces FLT3i, especially sorafenib, as standard post-HSCT maintenance in AML patients, with 2-year LFS exceeding 80% regardless of MRD status or prior FLT3i exposure. Additionally, HMA showed encouraging results with 2-year LFS >70% particularly among those with prior GVHD."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation

Updated overall survival in patients with prior checkpoint inhibitor therapy in the phase III TIVO-3 study. (PubMed, Oncologist) - "In this long-term post-hoc update of the TIVO-3 trial, we show that in CPI-resistant mRCC, the PFS benefit of tivozanib over sorafenib is accompanied with improved OS data, although not statistically significant, and durable responses."

Checkpoint inhibition • Clinical • Journal • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

AML16: A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=206 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Overall efficacy outcomes of nivolumab plus ipilimumab by occurrence of immune-mediated adverse events (IMAEs) and additional safety from Asian patients in CheckMate 9DW (ESMO Asia 2025) - P3 | "Background: In the phase 3 CheckMate 9DW trial, at a median follow-up of 35.2 months (mo), first-line nivolumab + ipilimumab (NIVO + IPI) showed significant overall survival (OS) benefit (median, 23.7 mo vs 20.6 mo; HR, 0.79 [95% CI, 0.65–0.96; P = 0.018]), higher objective response rate (ORR; 36% vs 13%; P < 0.0001) by blinded independent central review (BICR), and manageable safety vs lenvatinib (LEN) or sorafenib (SOR) in patients (pts) with unresectable hepatocellular carcinoma (uHCC). NIVO + IPI showed durable responses and long-term survival benefit regardless of IMAEs. IMAEs in Asian pts treated with NIVO + IPI occurred early and were manageable, consistent with the overall population. These results further support NIVO + IPI as a standard of care in uHCC."

Adverse events • Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Pooled efficacy and safety with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the mainland China extension cohort, and Hong Kong (HK) and Taiwan (TW) subgroups from the global cohort in the phase III HIMALAYA study (ESMO Asia 2025) - P3 | "Background: STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved overall survival (OS) vs sorafenib (S; hazard ratio [HR], 0.78) in pts with uHCC in the Phase 3 HIMALAYA study (NCT03298451). In this pooled analysis of the mainland China extension cohort and HK and TW subgroups, OS improved with STRIDE and D vs S, with manageable safety through 3 yrs of follow-up. STRIDE and D continued to show long-term survival benefit vs S in pts from HK and TW through 5-yr of follow-up. These results demonstrate a favourable risk-benefit profile for STRIDE and D in pts with uHCC in these populations."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Real-world outcomes of systemic therapy in patients with hepatocellular carcinoma and decompensated Child-Pugh C cirrhosis. (ASCO-GI 2026) - "Among the therapies used, sorafenib was most frequently used (42%), followed by lenvatinib, cabozantinib, regorafenib, atezolizumab plus bevacizumab, pembrolizumab, and durvalumab... In this real-world cohort of HCC patients with CPC cirrhosis, OS was 36.6% at 1 year, 25.3% at 2 years, 22.3% at 3 years, and 17.5% at 5 years. Frontline TKI therapy showed numerically higher survival than ICI-based regimens, though the difference did not reach statistical significance. These findings highlight the need for prospective studies to better define treatment strategies in this high-risk population."

Clinical • Real-world • Real-world evidence • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. (PubMed, J Clin Oncol) - P3 | "Compared with sorafenib, STRIDE and durvalumab were associated with clinically meaningful, patient-centered GHS/QoL, functioning, and symptom benefits in people with uHCC. These findings support the benefits of the STRIDE regimen compared with sorafenib for a diverse population reflective of the global uHCC population."

Journal • P3 data • Patient reported outcomes • Anorexia • Fatigue • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pain • Solid Tumor

Metabolic reprogramming-driven resistance to multi-kinase inhibitors in hepatocellular carcinoma: molecular mechanisms and therapeutic opportunities. (PubMed, Mol Cancer) - "Multi-kinase inhibitors (MKIs), such as sorafenib and lenvatinib, serve as first-line therapies for unresectable HCC. Additionally, this review synthesizes preclinical and clinical evidence of therapeutic agents that synergize with MKIs by modulating metabolic pathways, and discusses the regulatory role of metabolic reprogramming in the tumor immune microenvironment (TIME) of HCC, offering innovative strategies to improve treatment outcomes for patients with HCC. These findings highlight metabolic reprogramming as a crucial target for developing novel interventions aimed at overcoming MKI resistance in clinical practice."

Journal • Review • Hepatocellular Cancer • Liver Cancer • Metabolic Disorders • Oncology • Solid Tumor

Outcomes by baseline liver function in patients with unresectable hepatocellular carcinoma treated with tremelimumab and durvalumab in the Phase 3 HIMALAYA study (ESMO-GI 2022) - P3 | "Legal entity responsible for the study AstraZeneca. Conclusions STRIDE showed a favorable benefit-risk profile compared with sorafenib across ALBI subgroups. STRIDE and durvalumab may represent new treatment options in uHCC for patients with less optimal liver function."

Clinical • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Lenvatinib versus sorafenib as second-line therapy following failure of atezolizumab–bevacizumab in hepatocellular carcinoma: An updated systematic review and meta-analysis. (LCS 2026) - "Most included studies are observational and subject to potential bias and confounding; thus, the results do not definitively establish the overall advantage of one drug over the other. Further randomized controlled trials are needed to confirm these efficacy and safety differences in a more robust, prospective setting."

Retrospective data • Review • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial. (PubMed, J Clin Oncol) - "Nivolumab plus cabozantinib with or without ipilimumab showed encouraging preliminary antitumor activity and had consistent safety profiles with those established for the individual drugs in patients with advanced hepatocellular carcinoma."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) therapy for unresectable hepatocellular carcinoma (uHCC): CheckMate 9DW expanded analyses. (ASCO-GI 2025) - P3 | "These additional analyses from CheckMate 9DW demonstrate the efficacy and manageable safety of 1L NIVO + IPI in uHCC and further support its use as a potential standard-of-care treatment option in this setting. aIncludes non-CR/non-PD. CR, complete response; NR, not reached; PD, progressive disease; PR, partial response; SD, stable disease; TRAE, treatment-related adverse event."

Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial. (PubMed, Lancet) - P3 | "Nivolumab plus ipilimumab showed a significant overall survival benefit versus lenvatinib or sorafenib and manageable safety in patients with previously untreated unresectable hepatocellular carcinoma. These results support nivolumab plus ipilimumab as a first-line treatment in this setting."

Journal • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor • AFP

Temporal patterns of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC). (ASCO 2023) - P3 | "Background: In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, STRIDE (Single T Regular Interval D) significantly improved overall survival versus sorafenib (S) and had manageable safety (Abou-Alfa et al. In HIMALAYA, AEs with STRIDE were manageable and generally low grade. Any grade TRAEs and Grade 3 or 4 TRAEs were less frequent for STRIDE versus S. Although imAEs with STRIDE could occur at any time, most were observed within the first three months after treatment. These findings continue to support STRIDE for the treatment of uHCC."

Adverse events • P3 data • Endocrine Disorders • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatocellular Cancer • Oncology • Solid Tumor