Inlyta (axitinib) / Pfizer - LARVOL DELTA

Identification of novel HER2 ınhibitors: potential therapeutics for breast cancer. (PubMed, Discov Oncol) - "Among the tested compounds, axitinib, prunetin, and silymarin demonstrated strong HER2-binding affinities comparable to established inhibitors such as TAK-285 and lapatinib. Prunetin, with its lower toxicity and higher stability, presents a safer therapeutic option, whereas axitinib offers high binding affinity. These findings suggest that these compounds could help overcome resistance and side effects associated with current HER2-targeted therapies."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Immune-Related Fulminant Myocarditis Revealed Using Myocardial Histopathology at Autopsy in the Treatment of Advanced Renal Cell Carcinoma: A Case Report. (PubMed, Case Rep Oncol) - "Combination therapy with pembrolizumab and axitinib was initiated. Delay in the initiation of treatment is considered a risk factor for poor prognosis, and the administration of high-dose steroids within 24 h of onset contributes to a better outcome. Herein, we discuss the pathology, diagnosis, and treatment of immune checkpoint inhibitor-associated myocarditis."

Journal • Anorexia • Cardiovascular • Critical care • Fatigue • Genito-urinary Cancer • Hypotension • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Very first experience with 68Ga/177Lu-NYM096 in patients with metastatic clear cell renal cell carcinoma (SNMMI 2025) - P1 | "Purpose/Background: NYM096 is a new-generation carbonic anhydrase 9 (CA9) targeting small molecule that can be labeled with both 68Ga and 177Lu. One patient with metastatic ccRCC, aged 61 years, was enrolled. The patient had progressive disease after 2 lines of treatment (1st line, axitinib plus pembrolizumab, 2nd line, lenvatinib plus pembrolizumab). 68Ga-NYM096 PET/CT (Figure 1) demonstrated multiple CA9-positive metastases involving lung, pleural, LN, bone, soft tissue, and thyroid."

Clinical • IO biomarker • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

Efficacy and safety of SABR/partial-SABR combined with axitinib and toripalimab in recurrent or metastatic renal cell carcinoma: Preliminary results from a prospective phase 2 trial. (PubMed, Oncol Lett) - P2 | "The present trial was retrospectively registered at clinicaltrials.gov (registration no. NCT06889649; 03-03-2025)."

Journal • P2 data • Clear Cell Carcinoma • Fatigue • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Avelumab plus axitinib in patients with advanced gastrointestinal stromal tumor. (PubMed, Eur J Cancer) - "The results of the largest trial on the combination of targeted therapy and immunotherapy in pretreated GIST show the promising efficacy of this novel therapeutic approach in a subset of patients."

Journal • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Efficacy and safety of Tislelizumab combined with Axitinib as first-line treatment for intermediate- and high-risk metastatic clear-cell renal cell carcinoma. (PubMed, Front Pharmacol) - "Common AEs included gastrointestinal reactions (60%, 12/20), rash (40%, 8/20), and hypertension (30%, 6/20). Tislelizumab combined with Axitinib as first-line treatment for intermediate-high risk metastatic ccRCC showed significant efficacy and manageable safety."

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

RENOTORCH: Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer (clinicaltrials.gov) - P3 | N=421 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

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

ALARICE: Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy (clinicaltrials.gov) - P=N/A | N=23 | Completed | Sponsor: The University of Hong Kong | Active, not recruiting ➔ Completed

Trial completion • Cervical Cancer • Oncology • Solid Tumor

Hyaluronic acid-functionalized Axitinib nanomicelles for targeted drug delivery in breast cancer therapy. (PubMed, J Biomater Sci Polym Ed) - "These findings highlight the promise of HA-AXT-M as a targeted nanocarrier platform that enhances the therapeutic potential of Axitinib. This novel delivery system offers improved efficacy, tumour selectivity, and translational relevance for breast cancer therapy."

Journal • Breast Cancer • Oncology • Solid Tumor • CD44

Rechallenge of Immune Checkpoint Inhibitors in cancer patients with biopsy-confirmed renal injury: a case series. (ERA 2025) - "Most patients (n=6) were treated with the PD-1 inhibitor pembrolizumab, and one patient received a combination of two checkpoint inhibitors ipilimumab and nivolumab. Four patients were also treated with chemotherapy apart from ICI, and one also received targeted therapy (axitinib)...All patients experienced recovery of kidney function 2 months after the initiation of prednisone (among them the patient with DN/ATI who required renal replacement therapy at the time of biopsy) and the patient with nephrotic syndrome experienced partial remission of proteinuria. Reintroducing immunotherapy after AKI is feasible in selected cases after timely diagnosis and therapy of renal injury, especially when there is lack of alternative oncological treatment options and it requires close collaboration among nephrologists and oncologists to continue ICI therapy while safeguarding renal health."

Biopsy • Checkpoint inhibition • Clinical • Acute Kidney Injury • Chronic Kidney Disease • Dermatitis • Dermatology • Diabetic Nephropathy • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Glomerulonephritis • Hepatology • Immunology • Inflammatory Arthritis • Lung Cancer • Lupus • Nephrology • Non Small Cell Lung Cancer • Oncology • Pneumonia • Renal Cell Carcinoma • Renal Disease • Solid Tumor

Avelumab plus axitinib in patients with advanced gastrointestinal stromal tumor (Eur J Cancer) - P2 | N=58 | AXAGIST (NCT04258956) | "Of the 58 patients enrolled, 56 patients were evaluable for safety and efficacy. Median age was 60 years (range 18-80), and 30 patients (53.4%) had received three prior lines of TKIs. Median follow-up was 27.4 months. The best response was partial response in 5 patients (8.9%), stable disease in 34 patients (60.7%), and progressive disease in 17 patients (30.4%). Among patients with partial response, the median duration of response was 18.5 months (95%CI, 18.3-NA). The PFS rate at 3 months was 57.1%. Median PFS and OS were 4.6 months (95%CI, 2.9-6.4) and 14.2 months (95%CI, 9.2-26.3), respectively."

P2 data • Gastrointestinal Stromal Tumor

Newly emerging tyrosine kinase inhibitors for the treatment of neuroendocrine neoplasms. (PubMed, Expert Opin Emerg Drugs) - "So far sunitinib is the only tyrosine kinase inhibitor (TKI) available in clinical practice for NENs in Western countries, limited to advanced, progressing pancreatic neuroendocrine tumors (NETs)...Our work is focused specifically on a critical analysis of TKIs investigated in phase III clinical trials, such as Axitinib, Surufatinib and Cabozantinib. The Expert Opinion section of our manuscript is a critical overview of the results coming from phase II and III clinical trials with Axitinib, Surufatinib and Cabozantinib, and, it is mainly centered on strategies of investigation of these TKIs, including geographical areas and indirect comparison about study design."

Journal • Review • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Impact of multikinase inhibitors in reshaping the treatment of advanced gastroenteropancreatic neuroendocrine tumors. (PubMed, Endocr Relat Cancer) - "Current approaches in managing advanced GEP-NETs are discussed, including somatostatin analogs, surgery, peptide receptor radionuclide therapy (PRRT), and approved systemic treatments such as everolimus or sunitinib...Discussions focus on the clinical effectiveness and the emerging role of both established and novel MKIs in the treatment of GEP-NETs, including recent evidence from the CABINET trial and other emerging agents such as surufatinib, axitinib, pazopanib, and lenvatinib...There remain several unmet needs that must be addressed, particularly regarding optimal treatment sequencing and the development of predictive biomarkers. Ongoing research and the use of current and emerging MKIs hold great potential to advance the treatment landscape for advanced GEP-NETs significantly."

Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Cost-Utility and Budget Impact Analysis of Immunotherapy for First-Line Treatment of Advanced Kidney Cancer in Latin America: Evidence From Uruguay. (PubMed, Value Health Reg Issues) - "Nivolumab plus ipilimumab represents a cost-saving option for first-line aRCC treatment and a cost-effective regimen for patients with intermediate and poor-risk aRCC in Uruguay."

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

Validation of a 15-Gene Prognostic Signature in Metastatic Clear Cell Renal Cell Carcinoma. (PubMed, JCO Precis Oncol) - "The 15G score was independently prognostic in metastatic ccRCC among patients receiving different systemic therapy regimens."

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

Immune checkpoint inhibitor therapy in metastatic renal cell carcinoma: tumour response and immune-related renal vasculitis following cytoreductive nephrectomy. (PubMed, Pathologica) - "All patients were treated with ICI for a duration ranging from 6 to 20 months; 7 patients received combination therapy (CT) [iplimumab & nivolumab (n = 3), pembrolizumab & lenvatinib (n = 2), nivolumab & carbozantinib (n = 1), pembrolizumab & axitinib (n = 1)], while one received monotherapy (MT) (pembrolizumab). This study highlights the potential of ICIs for tumor downstaging and disease control in mRCC, though further investigation is warranted to optimize management of iRAEs and long-term outcomes. ICI-associated renal vasculitis is likely underrecognized and underreported highlighting the need for thorough pathological evaluation of non-neoplastic renal tissue in patients receiving ICI."

Checkpoint inhibition • Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Vasculitis

A machine learning-derived angiogenesis signature for clinical prognosis and immunotherapy guidance in colon adenocarcinoma. (PubMed, Sci Rep) - "However, axitinib and olaparib may be promising treatment options for such patients. Taken together, we constructed a prognostic CARS that provides prognostic stratification and elucidates the characteristics of the tumor microenvironment, which might guide the selection of personalized treatments for patients with COAD."

IO biomarker • Journal • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology

Risk of tumor lysis syndrome associated with kinase inhibitors: Analysis of FAERS and real-world data. (ASCO 2025) - " The current study presents a Disproportionality Analysis (DA) of FAERS data and explores Real-World Data (RWD) from TriNetX for the class of drugs known as Kinase Inhibitors (KIs) including Lenvatinib, Sorafenib, Sunitinib, Pazopanib, Axitinib and Cabozantinib... Analysis of FAERS and RWD revealed a considerable number of TLS cases post therapy with specified KIs indicating a need for inclusion of preventive measures including prophylaxis with hypouricemic agents, monitoring and early intervention for these therapies. The product labeling for this drug class may also require update to include relevant safety information, warnings and precautions. References: Tumor Lysis Syndrome in Patients With Solid Tumors: A Systematic Review of Reported Cases - PMC July - September 2024; Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS); FDA Disproportionality analysis with FAERS data (Data cut-off 30 Sep 2024).*..."

Clinical • Real-world • Real-world evidence • Acute Kidney Injury • CNS Disorders • Endocrine Disorders • Epilepsy • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor

Comparing RECIST, Choi, modified Choi (mChoi) and viable tumor volume (VTV) in predicting clinical benefit of vascular endothelial growth factor receptor inhibitors (VEGFRi) in patients (pts) with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC). (ASCO 2025) - "Pts with the following criteria were included: 1) biopsy-proven R/M ACC, 2) received at least one cycle (28 days) of lenvatinib or axitinib monotherapy in any line of treatment, 3) available baseline and at least one re-staging scan. Although RECIST was associated with TTNT, Choi was better able to identify responders with the longest real-world clinical benefit from VEGFRi. However, Choi was not predictive of treatment outcome among non-responders (SD or PD). Patients with SD per mChoi had the longest survival, but this may be related to confounding from ACC molecular subtype or other factors."

Clinical • Metastases • Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer

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 | "The preliminary results of T plus A combined with SBRT demonstrated promising efficacy and safety in the treatment of omRCC. Higher objective response rate was seen in irradiated lesions and in pts who had not received TKI. Further recruitment is ongoing."

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

Elevated hernia risk in renal cell carcinoma (RCC) patients treated with tyrosine kinase inhibitors (TKIs): A FAERS analysis. (ASCO 2025) - "Reports mentioning both RCC and TKI use were identified, specifically focusing on sunitinib, pazopanib, axitinib, cabozantinib, lenvatinib, bevacizumab, and tivozanib... Our FAERS analysis suggests a potential association between TKI use and increased hernia risk in patients with RCC. Further investigation using observational studies is crucial to confirm this association and explore underlying mechanisms. Future research should focus on validating these findings, elucidating the biological mechanisms involved, identifying risk factors, and developing clinical guidelines for hernia prevention and management in this patient population."

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

Hypertension and VEGF-A level correlation in cancer patients starting VEGF inhibitors: A prospective study. (ASCO 2025) - "VEGFi used were Sunitinib (n=21), Lenvatinib (n=14), Cabozantinib (n=8), Bevacizumab (n=5), Axitinib (n=4), and Pazopanib (n=3)... Approximately 70% of patients developed grade 2 HTN within one week of starting VEGFi, and about half had onset of sub-nephrotic proteinuria by week 12. VEGF-A levels after treatment correlated positively with diastolic BP at week 1. This highlights the importance of early monitoring of HTN and proteinuria."

Clinical • Cardiovascular • Diabetes • Endocrine Cancer • Genito-urinary Cancer • Hypertension • Kidney Cancer • Metabolic Disorders • Nephrology • Neuroendocrine Tumor • Oncology • Renal Cell Carcinoma • Renal Disease • Sarcoma • Solid Tumor

The impact of nephrectomy on the clinical outcomes of first-line immunotherapy and tyrosine kinase inhibitors combinations versus sunitinib in advanced renal cell carcinoma: A meta-analysis of randomized studies. (ASCO 2025) - "The IO+TKI regimens comprised: Avelumab+Axitinib, Nivolumab+Cabozantinib, and Toripalimab plus Axitinib... This meta-analysis highlights the differential impact of therapeutic nephrectomy on the efficacy of first-line IO+TKI combinations compared to Sunitinib in advanced RCC. It suggests that therapeutic nephrectomy may enhance the survival benefits of IO+TKI therapy in advanced RCC. Further prospective studies are warranted to better define the role of nephrectomy in optimizing outcomes for patients receiving modern combination therapies."

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

The impact of firstline immunotherapy and tyrosine kinase inhibitors combinations versus sunitinib on clinical outcomes of favorable risk advanced renal cell carcinoma: A meta-analysis of randomized studies. (ASCO 2025) - "The IO+TKI regimens comprised: Avelumab+Axitinib, Nivolumab+Cabozantinib, Pembrolizumab+Lenvatinib, and Pembrolizumab+Axitinib... This meta-analysis demonstrates that while first-line IO+TKI combinations significantly improve PFS compared to Sunitinib in IMDC favorable risk advanced RCC, they do not confer a statistically significant OS benefit. Nevertheless, this superior PFS observed with IO+TKI regimens suggests enhanced disease control, which is still a meaningful clinical outcome."

Clinical data • Metastases • Retrospective data • Clear Cell Carcinoma • 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) - "Nivolumab and pembrolizumab, both PD-1 inhibitors, differ in their propensity to induce immune-related adverse events (irAEs), such as colitis. Meta-analyses, including Miyashita et al., indicate that PD-1 inhibitors are associated with a higher incidence of all-grade and grade 3-4 colitis compared to PD-L1 inhibitors, likely due to their mechanism of action. Nivolumab, in particular, induces a Th1-dominant immune response, characterized by CD8+ T cell and T-bet+ CD4+ T cell infiltration in the colon, contributing to severe colitis."

Clinical • Metastases • Autoimmune Hepatitis • Clear Cell Renal Cell Carcinoma • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hepatology • Immunology • Inflammation • Oncology • Solid Tumor • CD4 • CD8