Lenvima (lenvatinib) / Eisai, Merck (MSD), Knight Therap - LARVOL DELTA

Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study. (PubMed, Sci Rep) - "No significant differences were observed in PFS and OS between the two groups (p = 0.14 and p = 0.44, respectively). Pembrolizumab plus lenvatinib demonstrated favorable efficacy and manageable safety in a real-world cohort of patients with mRCC, including older adults."

Journal • Real-world evidence • Retrospective data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

High-throughput screening uncloaks actionable compounds for ttmv::rara AML (ASH 2025) - "Clinical data from ourmulticenter cohorts (n=25) revealed that 20 patients showed initial response to conventional APLregimens including all-trans retinoic acid (ATRA) and arsenic trioxide (ATO), but paradoxicallydemonstrated poor disease control, evidenced by the event-free survival (EFS) was 53.6% with relapse-free survival (RFS) exceeding to 53.8% beyond 2 years...Dose-response curves revealed significant half maximalinhibitory concentration (IC50) reductions (>5-fold) relative to vector controls in 5/10 candidates:anagrelide (phosphodiesterase III inhibitor), lenvatinib (multi-kinase inhibitor), cytarabine (nucleosideanalog), cyclocytidine (prodrug of cytarabine), and tandutinib (FLT3 inhibitor). Crucially, the establishedAPL therapies ATRA and ATO, as well as the widely used BCL2 inhibitor venetoclax, showed no significantreduction in IC50, suggesting a possible link to the clinical observation of rapid relapse in this disease.Our findings establish the human..."

Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • CD33 • CD34 • CEACAM8 • FLT3 • ITGAM • PTPRC

Inflammation-driven mechanisms in endometrial cancer: pathways from inflammatory microenvironment remodeling to immune escape. (PubMed, Front Immunol) - "Advancements in single-cell analysis and spatial transcriptomics are anticipated to unveil actionable molecular patterns and support the development of individualized strategies to interrupt immune evasion and therapeutic resistance in EC. These advances offer promise for personalized immunotherapy approaches that could significantly improve outcomes in endometrial cancer patients."

IO biomarker • Journal • Review • Endometrial Cancer • Oncology • Solid Tumor • IL10 • IL6 • PD-1 • STAT3 • TGFB1 • TNFA

Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Efficacy and safety of toripalimab combined with Lenvatinib as first-line treatment for unresectable/advanced non–clear cell renal cell carcinoma: A prospective, single-arm, phase II trial (ESMO Asia 2025) - P=N/A | "The KEYNOTE-B61 study showed that pembrolizumab plus lenvatinib offers favorable efficacy and safety in advanced nccRCC, yet evidence for alternative first-line regimens remains limited. Toripalimab combined with lenvatinib showed promising antitumor activity and manageable toxicities as a first-line treatment for unresectable or advanced nccRCC."

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor • TFE3

A new era in metastatic endometrial carcinoma: Integrating chemotherapy, immunotherapy, targeted therapy and antibody-drug conjugates (ESMO Asia 2025) - "This case illustrates an evolving treatment landscape, including the use of immunotherapy and trastuzumab deruxtecan (Tdxd) in the HER2 2+ setting...She received first line therapy with paclitaxel and carboplatin...She presented with disease progression in feb 2023, for which she received 2nd line pembrolizumab and lenvatinib till oct 2023... This case highlights the shifting treatment paradigm in advanced endometrial carcinoma, demonstrating how the sequential use of chemotherapy, immunotherapy, targeted therapy, and radiotherapy can extend disease control and improve survival. It highlights the potential role of Tdxd in HER2-low metastatic endometrial carcinoma, even in heavily pretreated patients. Careful toxicity monitoring is essential to optimize outcomes."

Metastases • Endometrial Cancer • Oncology • Solid Tumor • CCNE1 • ER • HER-2 • TP53

Prophylactic effect of diclofenac sodium gel on hand-foot syndrome in patients with gastrointestinal cancer treated with tyrosine kinase inhibitors : A single-center prospective observational study (ESMO Asia 2025) - "Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, tolerability, and QOL (The HFS-14 questionnaire). Between January 2024 and May 2025, 31 patients were enrolled (median age: 67 years [range: 51-80]; male/female: 58%/42%; performance status [PS] 0/1/2: 36%/61%/3%; primary tumor site: colorectal/hepatocellular carcinoma/gastrointestinal stromal tumor: 77%/16%/7%; TKIs: regorafenib/lenvatinib/fruquintinib/sorafenib/sunitinib: 77%/10%/7%/3%/3%. Diclofenac sodium gel application did not reduce the incidence of TKIs-induced grade ≥2 HFS, compared to than the known reports of capecitabine-induced HFS. However, there were no grade≥ 3 HFS and treatment discontinuation due to HFS. Further research on the preventive effects of diclofenac sodium gel for HFS induced by TKIs is warranted."

Clinical • Observational data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Hepatocellular Cancer • Oncology • Sarcoma • Solid Tumor

Drug utilisation evaluation of oral anticancer therapy in a south indian cancer centre (ESMO Asia 2025) - "Among targeted therapies, Gefitinib, Osimertinib, Crizotinib, Afatinib, Lorlatinib, and Nilotinib demonstrated consumption of 30 DDDs per patient over 30 days. Lower consumptions were observed with Lenvatinib and Cabozantinib with 13.3 DDDs and 11.25 DDDs per patient respectively. In the hormonal therapy group, Letrozole, Tamoxifen, Bicalutamide, Anastrozole, Enzalutamide, and Exemestane were all prescribed in line with WHO standards (30 DDDs per patient), whereas Abiraterone exhibited lower consumption of 15 DDDs per patient. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Dose deviations occurred, though reasons were unclear and may relate to adverse effects, indication-specific or patient factors, or economic constraints. Further research is warranted..."

Oncology • Oral Cancer

The impact of platinum-free interval on the efficacy of lenvatinib/pembrolizumab in advanced or recurrent endometrial cancer (ESMO Asia 2025) - "The LP therapy was more effective in patients with longer PFIs following platinum-based chemotherapy compared to those with shorter PFIs."

Clinical • Metastases • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI

Long term real-world outcomes of first-line immunotherapy (IO) and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) combination in metastatic clear cell renal cell carcinoma (mRCC): Does the type of IO or VEGF-TKI matter? (ESMO Asia 2025) - "Background: First-line treatment of mRCC involves a combination of IO with a VEGF-TKI, or dual IO using nivolumab + ipilimumab...31 (60%) patients received nivolumab and 21 pembrolizumab, while the VEGF-TKI was lenvatinib in 34 (65%) and axitinib in 18... The combination of IO and VEGF-TKIs demonstrated robust efficacy in our mRCC cohort, with high ORR, minimal primary progression, and favourable survival. We recommend using IO in combination with a VEGF-TKI, based on availability, side-effects and experience, as no significant differences were observed between individual IO agents or VEGF-TKIs. Grade 3/4 IRAEs may occur, highlighting the need for early detection and timely intervention."

Clinical • Metastases • Real-world • Real-world evidence • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Immune-related adverse events associated with first-line immune checkpoint inhibitors-based therapy for metastatic renal cell carcinoma (ESMO Asia 2025) - "Background: To assess Immune-related toxicity and safety of first-line immune checkpoint inhibitors-based therapy in metastatic renal cell carcinoma (mRCC) patients treated in real-world clinical practice. The retrospective study included data of 194 patients ≥18 years, with verified mRCC, treated with upfront combined immunotherapy, IO-IO (nivolumab + ipilimumab, 94 (48.5%) patients) or immune-targeted therapy, IO-TKI (100 (51.5%) patients: pembrolizumab + axitinib (85 (43.8%)) or lenvatinib (10 (5.2%)), nivolumab + cabozantinib (5 (2.6%)) from 07.07.2019 to 22.10.2024 at Moscow City Hospital named after S.S. Yudin... Real-world practice data confirmed results of randomized trials regarding with irAEs rate and spectrum but demonstrated higher severe and multiple irAEs frequency in mRCC patients treated with upfront immune checkpoint inhibitors-based therapy. IO-IO was associated with higher rate of multiple irAEs and immune-related renal toxicity comparing IO-TKI."

Adverse events • Checkpoint inhibition • Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for conversion treatment of potentially resectable, locally advanced biliary tract cancers: A single-arm, exploratory clinical study (ESMO Asia 2025) - P2 | "HAIC consisted of infusions of gemcitabine (1000 mg for 2 hours) and cisplatin (37.5 mg/m2 for two doses, 24 hours apart, 2 hours each time)± 5-FU (1250 mg/m2 for 48 hours) on day1-3 every 3 weeks...The primary endpoints are R0 resection rate and surgical conversion rate, secondary endpoints include pathologic complete remission, major pathological response, recurrence-free survival, overall survival, patient-reported outcome and safety. An analysis of biomarkers will be performed to predict response or resistance to the treatment."

Clinical • IO biomarker • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • PD-L1

A comparative research of neoadjuvant and postoperative adjuvant therapy for hepatocellular carcinoma with high-risk recurrence factors: A Multicenter, prospective, randomized controlled clinical study (ESMO Asia 2025) - P2 | "The experimental group will receive 4 cycles of tislelizumab (200 mg, q3w) and lenvatinib (8 mg, po, qd), followed by surgical resection and adjuvant tislelizumab plus lenvatinib for 6 months. Secondary endpoints include overall survival, rate of preoperative progression and surgical delay of 6 weeks in the experimental group, the incidence of microvascular invasion and satellite lesions in postoperative pathological specimens, and safety. The study is currently recruiting pts."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

TREMENDOUS-2: An open-label, multi-center phase II study of durvalumab and tremelimumab with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (ESMO Asia 2025) - P2, P3 | "Background: In the global phase III HIMALAYA study (NCT03298451), a single, high priming dose of tremelimumab (anti-CTLA4) plus durvalumab (anti-PD-L1) termed STRIDE demonstrated statistically significant and clinically meaningful improvement in OS vs. sorafenib for the 1L treatment of pts with unresectable hepatocellular carcinoma (uHCC) (median OS of 16.4 vs. 13.8 months, HR=0.78), with a manageable safety profile. The key secondary endpoint is Grade ≥3 treatment-related adverse events within 6 months after treatment initiation. Other secondary endpoints include OS, ORR, DOR, DCR per RECIST 1.1 and PFS per mRECIST and safety."

Clinical • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

Real-world outcomes of patients with advanced hepatocellular carcinoma: A retrospective cohort study (ESMO Asia 2025) - "Background: Atezolizumab plus bevacizumab (A + B) is standart first-line treatment for advanced HCC (aHCC)...A+B was administered in 17 (10.7%) pts, lenvatinib was administered in 67 (42.1%) pts, and sorafenib was administered in 70 (44%) pts...Lenvatinib and nivolumab were the most commonly administered 2nd regimens (24.1% and 25.9%, respectively)... Only one-third of pts received 2nd-line therapy for aHCC. TKI-based therapy post-lenvatinib exposure results in longer OS than switching to ICIs. Preserved liver function (ALBI G1) and good PS (ECOG PS 0-1) were associated with improved OS."

Metastases • Real-world • Real-world evidence • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

A network meta-analysis comparative the efficacy of lenvatinib versus atezolizumab plus bevacizumab and sorafenib in the treatment of unresectable hepatocellular carcinoma (ESMO Asia 2025) - "Atezolizumab+Bevacizumab, Levatinib, and sorafenib demonstrated similar therapeutic efficacy based on overall survival."

Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

TACE plus lenvatinib and tislelizumab as perioperative therapy in resectable hepatocellular carcinoma at CNLC stages IB and IIA: A prospective, single-arm, phase II trial (ESMO Asia 2025) - P2 | "This perioperative triple therapy achieved favorable pathological response rate with a manageable safety profile. As the study remains ongoing, assessment of long-term survival benefits requires further evaluation with longer follow-up."

Clinical • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

ETN101 Suppresses tumor growth via inhibition of Wnt/β-catenin signaling in hepatocellular carcinoma models (ESMO Asia 2025) - P1 | "Although atezolizumab plus bevacizumab is standard first-line treatment, its efficacy is limited in Wnt-driven tumors. Similarly, sorafenib and lenvatinib show modest responses, indicating high unmet need... ETN101 inhibits Wnt/β-catenin signaling and shows strong antitumor activity in preclinical HCC models, including drug-resistant settings. A phase I clinical trial is ongoing (NCT06326502)."

Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • WNT3A

FOLFOX-HAIC combined with lenvatinib and tislelizumab for hepatocellular carcinoma with arteriovenous shunts: A real-world study (ESMO Asia 2025) - "All patients received hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 via intra-arterial infusion pump, followed by 5-FU 400 mg/m2 IV bolus and 2400 mg/m2 continuous arterial infusion over 46 hours) in combination with oral lenvatinib and intravenous tislelizumab (200 mg every 3 weeks). A total of 51 uHCC (median age 56 years; BCLC C 86.3%) were enrolled... FOLFOX-HAIC combined with lenvatinib and tislelizumab demonstrates a high arterioportal shunt (APS) occlusion rate, significantly improves tumor response, and prolongs PFS and OS in uHCC patients with arteriovenous shunts (AVS)."

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

Triplet therapy with tyrosine kinase inhibitors, immune checkpoint inhibitors, and TACE in hepatocellular carcinoma: A systematic synthesis of clinical evidence and alignment with emerging trials (ESMO Asia 2025) - P2, P2/3, P3 | "However, outcomes across disease stages and treatment settings remain fragmented. Six clinical studies (n > 600) evaluating lenvatinib plus tislelizumab with or without TACE (TLT vs. TL) in unresectable, intermediate, and resectable HCC were synthesized systematically. TLT demonstrates robust antitumor activity, favorable resection outcomes, and a tolerable safety profile across the HCC disease spectrum. Importantly, this strategy aligns with a growing number of ongoing clinical trials (e.g., NCT05613478, NCT05250843, NCT05920863) evaluating TLT in neoadjuvant, resectable, and "window-of-opportunity" settings with endpoints including RFS, pathologic response, and safety. This convergence of retrospective evidence and prospective validation highlights the emergence of TLT as a compelling candidate for a new standard of care in intermediate and advanced HCC."

Checkpoint inhibition • Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

NEK7-mediated EGFR Ser1070 phosphorylation promotes acquired lenvatinib resistance in hepatocellular carcinoma (ESMO Asia 2025) - "Our results unveil insights into the acquired lenvatinib resistance mechanism that NEK7 phosphorylates EGFR at S1070 to promote acquired lenvatinib resistance in HCC."

Hepatocellular Cancer • Oncology • Solid Tumor • EGFR

Cadonilimab plus lenvatinib (LEN) and hepatic arterial infusion chemotherapy (HAIC)-FOLFOX as conversion therapy in unresectable hepatocellular carcinoma (uHCC) (CCGLC-011): Interim results from a phase II trial (ESMO Asia 2025) - P2 | "Pts received HAIC-FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-FU bolus 400 mg/m2 and infusion 2400 mg/m2, Q3W), cadonilimab (10 mg/kg IV, Q3W) and LEN (12 or 8 mg, QD)... Cadonilimab plus LEN and HAIC-FOLFOX showed robust antitumor activity and acceptable safety, enabling curative-intent conversion in initially uHCC pts."

IO biomarker • P2 data • Tumor mutational burden • Hepatocellular Cancer • Oncology • Solid Tumor • CTLA4 • PD-1 • TMB

Clinical outcome of first-line systemic treatment in patients with hepatocellular carcinoma with portal vein thrombosis (ESMO Asia 2025) - "There were 49%, 27%, 20%, 4% of patients were treated with sorafenib (SOR), Lenvatinib (LEN), atezolizumab/bevacizumab (Atezo/Bev), and durvalumab/tremelimumab (Durva/Treme), respectively. In this real-world data, HCC with PVT had a significantly poorer prognosis compared to those without. Although, combination immune check point inhibitors had higher ORR, there was no difference in term of PFS and OS when compared with LEN or SOR."

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

Real-world effectiveness and safety of second-line lenvatinib and sorafenib after atezolizumab plus bevacizumab in patients with HCC: A multi-center analysis from the LINK research network in Korea (ESMO Asia 2025) - "In this study, 2L LEN demonstrated favorable effectiveness and lower incidence of hepatotoxicity than SOR following A+B in HCC. These suggest LEN is a promising 2L option for HCC post-immunotherapy, necessitating further investigation."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Hepatocellular Cancer • Oncology

Efficacy and safety of quadruple-modality therapy (Interventional therapy, radiotherapy, targeted therapy, and immunotherapy) in intermediate and advanced unresectable hepatocellular carcinoma: A prospective phase II study (ESMO Asia 2025) - "The treatment protocol involved TACE or HAIC as the initial locoregional therapy, followed by combined targeted therapy (e.g., sorafenib or lenvatinib) and immunotherapy (e.g., atezolizumab or pembrolizumab). This phase II study demonstrates that quadruple-modality therapyshows promising efficacy and acceptable safety in intermediate-advanced unresectable HCC. The integrated approach achieved notable tumor response and disease control while maintaining manageable toxicity."

Clinical • Metastases • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor