Inlyta (axitinib) / Pfizer - LARVOL DELTA

Preliminary efficacy and safety results of tislelizumab (T) and axitinib (A) combined with stereotactic body radiation therapy (SBRT) in the treatment of oligometastatic renal cell carcinoma (omRCC): A single-center phase II study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: ChiCTR2200067043 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Risk of autoimmune hepatitis, non-infectious gastroenteritis, and colitis among patients with metastatic clear cell renal cell carcinoma (ccRCC) treated with pembrolizumab/axitinib vs nivolumab/ipilimumab. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Autoimmune Hepatitis • Clear Cell Renal Cell Carcinoma • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hepatology • Immunology • Oncology • Solid Tumor

Exploratory analysis from NEOAVAX, a neoadjuvant trial of avelumab/axitinib in patients (pts) with localized renal cell carcinoma (RCC) who are at high risk of relapse after nephrectomy. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03341845 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase 2 study of axitinib + nivolumab in mucosal melanoma with pilot addition of stereotactic body radiotherapy or ipilimumab in select progressors. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05384496 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

P2 data • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

AREN1721, a randomized phase 2 trial of axitinib+nivolumab combination therapy vs. single agent nivolumab for the treatment of TFE/translocation renal cell carcinoma (tRCC) across all age groups, an NCI National Clinical Trials Network (NCTN) phase 2 study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03595124 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Efficacy and safety of neoadjuvant toripalimab plus axitinib in renal cell carcinoma with tumor thrombus: A combined analysis of two phase II trials. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04118855 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Thrombosis

Deciphering aging-associated prognosis and heterogeneity in gastric cancer through a machine learning-driven approach. (PubMed, iScience) - "Drug sensitivity analyses indicated that patients with high ELK3 expression may respond to FDA-approved drugs (axitinib, dacarbazine, crizotinib, and vincristine). Finally, a user-friendly Shiny application was created to facilitate access to the prognostic model and molecular subtype classifier for GC."

Heterogeneity • IO biomarker • Journal • Gastric Cancer • Oncology • Solid Tumor

Validation of a 15-Gene Prognostic Signature in Metastatic Clear Cell Renal Cell Carcinoma (AUA 2025) - "Treatment and control arms from all trials were included and grouped within treatment groups which included atezolizumab, atezolizumab plus bevacizumab, sunitinib, avelumab plus axitinib, nivolumab, and everolimus. The 15G score was independently prognostic in metastatic ccRCC among a diverse cohort of patients receiving different systemic therapy regimens."

Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Incidence and impact of immune combination therapies adverse events in advanced renal cell carcinoma patients. (PubMed, Immunotherapy) - "We included patients treated with nivolumab/ipilimumab (NI), nivolumab/cabozantinib (NC), or pembrolizumab/axitinib (PA) at four Italian oncology centers between November 2023 and June 2024...AEs are common in ICI-based therapies for RCC. While they do not negatively affect survival, their management, especially through dose reductions or steroids, may improve outcomes."

Adverse events • Journal • Cardiovascular • Dermatology • Genito-urinary Cancer • Hypertension • Mucositis • Oncology • Pruritus • Renal Cell Carcinoma • Solid Tumor

A phase II trial of sitravatinib + nivolumab after progression on immune checkpoint inhibitor in patients with metastatic clear cell RCC. (PubMed, Oncologist) - P2 | "In this small phase 2 trial with limited sample size due to early termination, sitravatinib plus nivolumab demonstrated a manageable safety profile and produced modest clinical benefit. The observed responses occurred in patients who did not receive prior treatment with cabozantinib or lenvatinib. (ClinicalTrials.gov Identifier: NCT04904302)."

Checkpoint inhibition • Journal • P2 data • Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma

International Multicentric Study ARON-1 (clinicaltrials.gov) - P=N/A | N=1220 | Recruiting | Sponsor: Hospital of Macerata | Trial completion date: Dec 2024 ➔ Sep 2027

Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Leveraging Tumor Organoids to Model Drug Response in Clear Cell Renal Cell Carcinoma (AUA 2025) - "The PDTOs were treated with standard-of-care TKIs, including Cabozantinib, Lenvatinib, and Axitinib, to generate dose-response curves...Ipilimumab, Nivolumab, and Pembrolizumab were tested both as monotherapies and in combination, revealing heterogeneous sensitivity and resistance profiles within the co-cultures. This approach, which accurately replicates the tumor microenvironment, facilitates comprehensive drug screening and may identify optimal treatments and resistance mechanisms. Ultimately, it seeks to develop a predictive, personalized model to support improved clinical decision-making in the management of ccRCC."

IO biomarker • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • BAP1 • CAFs • PBRM1 • SETD2

MLH1 Mismatch Repair Predicts Exceptional Responder Phenotypes in Clear-Cell Renal Cell Carcinoma (AUA 2025) - "In the CheckMate 214 nivolumab plus ipilimumab arm, all patients with MLH1 deficiency had ER, while in the JAVELIN Renal 101 avelumab plus axitinib arm, patients with MLH1 deficiency had significantly longer PFS. MLH1 deficiency in ccRCC can be identified using genomic data, and though rare, may be one of the most reliable predictors of exceptional response reported to date. This could have implications on the choice of ICI regimens in some patients with metastatic disease. With recent evidence supporting adjuvant treatment with pembrolizumab, it could also refine patient selection for peri-operative ICI therapy."

IO biomarker • Mismatch repair • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6 • PMS2

Evaluating immunotherapy and combination therapy efficacy in kidney cancer using a multicellular 3D immune-microtumor model (AACR 2025) - P | "FDA-approved RCC therapies, including immunotherapies (e.g. ipilimumab, nivolumab, pembrolizumab) and TKIs (e.g. axitinib, lenvatinib), are administered as monotherapies or in combination. This functional analysis reveals intra-patient response variability, underscoring the immune-microtumor model's potential to capture personalized RCC responses to combination therapies.This 3D immune-microtumor model allows for precise ex vivo testing of combination therapies in RCC, capturing patient-specific interactions within a functional TiME. Current clinical validation in the PEAR-TREE2 RCC trial (NCT06264479) aims to further correlate ex vivo findings with in vivo outcomes, holding promise to guide optimized, personalized RCC treatment."

Combination therapy • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8

Elucidation of novel β-catenin-driven aerobic glycolysis pathway in Triple Negative Breast Cancers (GBCC 2025) - "In conclusion, this study is the first to identify a novel β-catenin-regulated aerobic glycolysis pathway in TNBC, demonstrating that Axitinib is a more effective inhibitor of this pathway, compared to XAV939."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTNNB1 • LDHA • PFKP • SLC16A1

Survivin-based vaccine induces durable tumor regression when integrated with specific sequential antiangiogenic and immune checkpoint therapies (ITOC 2025) - "Conclusions This study demonstrates that the survivin peptide vaccine, when precisely integrated with Axitinib and anti-PD1, achieves a clear synergy on profound tumor regression and durable immune responses in an orthotopic renal carcinoma model. Tritherapy significantly outperforms monotherapies and double combinations in tumor control. These findings underscore the critical role of treatment sequencing and position the vaccine as a cornerstone for innovative combinatorial cancer therapies."

Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BIRC5 • CD4 • CD8 • GZMB • IFNG • IL2

Anti-angiogenic tyrosine kinase inhibitors and the pathophysiology of their toxic effects: revisiting the treatment of anemia in metastatic cancers. (PubMed, Exp Hematol Oncol) - "We deciphered the pathophysiology of anti-angiogenic TKI-induced anemia, which we observed to be mainly linked to a direct effect on normal bone-marrow vessels and to autophagy flux inhibition in erythroid progenitors under sunitinib."

Journal • Anemia • Hematological Disorders • Oncology

Treatment of Stage III clear-cell renal cell carcinoma in solitary kidney with neoadjuvant chemoimmunotherapy and robotic right partial nephrectomy with tumor thrombectomy (AUA 2025) - "Kidney-sparing surgery was safely performed in this patient with a solitary right kidney that recieved neoadjuvant pembrolizumab and axitinib for non-metastatic RCC and VTT into the renal vein. The patient had recovery of kidney function without need for dialysis."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • Thrombosis

Efficacy and Safety of Tislelizumab plus Axitinib in the Treatment of Locally Advanced Clear Cell Renal Cell Carcinoma:A single-center phase Ⅱ clinical study (AUA 2025) - "Tislelizumab combined with axitinib neoadjuvant therapy demonstrates significant clinical efficacy and manageable safety in patients with locally advanced ccRCC. Patients detected to carry PTEN and/or TERT mutations may need to seek newer options to meet their disease treatment needs."

Clinical • Metastases • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Endocrine Disorders • Genito-urinary Cancer • Hematological Disorders • Oncology • Solid Tumor • Thrombosis • BAP1 • PBRM1 • PTEN • TERT

Efficacy of presurgical therapy with tislelizumab and axitinib to downsize local lesions in locally advanced and metastatic renal cell carcinoma: a single-institution experience with long-term follow-up. (PubMed, Transl Androl Urol) - "Progression-free survival (PFS) and overall survival (OS) were significantly longer in patients who underwent nephrectomy (P=0.002 and P=0.004). Short-term presurgical tislelizumab and axitinib can downsize local lesions and facilitate nephrectomy in advanced RCC with high anatomical complexity, potentially improving long-term oncological outcomes when followed by cytoreductive surgery."

Journal • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

β-catenin-mediated aerobic glycolysis: a marker of poor prognosis in triple-negative breast cancer (AACR 2025) - "In conclusion, this study is the first to identify a novel β-catenin-regulated aerobic glycolysis pathway in triple-negative breast cancer (TNBC). We also demonstrated that Axitinib is a more effective inhibitor of this pathway than XAV939."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTNNB1 • LDHA • PFKP • SLC16A1

Prognostic implications of gastric cancer-specific tsRNA subtypes and functional validation (AACR 2025) - "High-risk patients responded well to axitinib, bexarotene, and dasatinib, while low-risk patients responded well to immunotherapy. In this study, tsRNA-related indicators accurately predicted the prognosis of gastric cancer and provided insight into the response of GC patients to therapeutic drugs. Gly-tsRNA-4 may act as a tumor suppressor to inhibit gastric cancer progression. The above study can help to explore new targets for gastric cancer treatment, but further comprehensive validation is needed."

IO biomarker • Gastric Cancer • Oncology • Solid Tumor

Pre-clinical research of ZHB015, an anti-CD26/CD3 bispecific T-cell-engaging antibody (AACR 2025) - "Although FDA approved axitinib in combination with avelumab as the first-line treatment for PD-L1 positive advanced renal cell carcinoma in 2019, the problems still exist such as individual differences and drug tolerance. ZHB015 simultaneously binds to tumor CD26 and T cell CD3, inducing T cell mediated antitumor effects. ZHB015 has an outstanding anti-tumor activity in vitro and in vivo, which is superior to YS110 and the current first line treatment. Thus, ZHB015 is being further developed as a potential therapy for CD26 positive solid tumor."

IO biomarker • Preclinical • Genito-urinary Cancer • Kidney Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • DPP4 • PD-L1

Multi-modal machine learning identifies predictive biomarkers of response to neoadjuvant axitinib in renal cell carcinoma with venous tumor thrombus (AACR 2025) - "Early changes in PlGF and sTie-2 may serve as actionable biomarkers for patient stratification. Further validation in independent datasets is essential to facilitate clinical integration and improve personalized treatment strategies for RCC patients with VTT."

Biomarker • Clinical • Machine learning • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Farnesyl transferase inhibitor KO-2806 enhances the antitumor activity of cabozantinib in ccRCC tumors that progress on anti-VEGFR agents (AACR 2025) - P1, P3 | "The combination of KO-2806 and cabozantinib led to deeper and more consistent tumor growth inhibition than cabozantinib alone in tumor models that had progressed on axitinib or lenvatinib, two TKIs used to treat RCC...Taken together, our findings demonstrate that KO-2806 augments the antitumor activity of cabozantinib, even after prior exposure to anti-VEGFR treatment, largely by enhancing anti-angiogenesis via mTORC1 signaling inhibition in endothelial cells. These data strongly support our clinical evaluation of KO-2806 as a combination partner with cabozantinib in ccRCC as part of the ongoing Phase 1 FIT-001 trial (NCT06026410)."

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD31 • PECAM1 • RHEB