axitinib / Generic mfg. - LARVOL DELTA

A prospective, multi-center, phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non–clear cell renal cell carcinoma. (ASCO 2026) - P1/2 | "Cadonilimab combined with axitinib demonstrated encouraging efficacy and tolerability as first-line therapy in advanced nccRCC across subtypes in this multi-center phase Ib/II study. Summary of efficacy analysis and tumor response review per RECIST v1.1."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • CNS Disorders • Dyslipidemia • Genito-urinary Cancer • Hypertriglyceridemia • Myasthenia Gravis • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Disease • Solid Tumor • PD-L1

Cadonilimab or ivonescimab plus axitinib in metastatic mucosal melanoma: Results from a phase Ib trial. (ASCO 2026) - P1 | "The combination therapy involving cadonilimab or ivonescimab plus axitinib demonstrates a promising safety and efficacy profile. These findings suggest that such dual-antibody-based regimens could provide synergistic anti-tumor activity with an improved therapeutic index, warranting further clinical investigation."

Metastases • P1 data • Anorexia • Cutaneous Melanoma • Dyslipidemia • Endocrine Disorders • Hypertension • Melanoma • Mucosal Melanoma • Musculoskeletal Pain • Renal Disease • Solid Tumor • BRAF

Pretreatment 18F-FDG PET/CT Radiomics for Predicting Response to First-Line Targeted Therapy Plus Immunotherapy in Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=228 | Completed | Sponsor: First Affiliated Hospital of Fujian Medical University

New trial • 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

Sintilimab Plus Axitinib for Advanced Fumarate Hydratase-Deficient Renal Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This combination therapy warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT04387500."

Clinical • Journal • P2 data • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertriglyceridemia • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • FH

SWOG S1931 (PROBE): Phase III randomized trial of immune checkpoint inhibitor (ICI) combination regimen with or without cytoreductive nephrectomy (CN) in advanced renal cancer. (ASCO-GU 2022) - P3 | "CARMENA trial demonstrated no change in overall survival with addition of nephrectomy to sunitinib therapy... Eligible patients with primary tumor and metastases are treated with one of the FDA approved ICI based combinations: ipililumab and nivolumab, axitinib and pembrolizumab, or axitinib and avelumab. Cabozantinib + nivolumab and lenvatinib + pembrolizumab combinations are being added into the next amendment...The study hypothesis is that CN will result in improvement in OS outcomes in advanced synchronous RCC post-initial systemic immune checkpoint based combination therapy. With a sample size of 302 eligible, randomized participants (151 per arm) and a one-sided alpha = 0.025, the study has 85% power to detect a 47% improvement in median survival (HR = 0.68; 1/0.68 = 1.47)"

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

Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3. (PubMed, Oncologist) - "Tivozanib is active in the treatment of patients with mRCC who have progressed on prior therapies, including axitinib."

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

Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study. (PubMed, Eur Urol) - "These results support pembrolizumab plus axitinib as a standard of care for patients with previously untreated advanced ccRCC. PATIENT SUMMARY: Extended results of KEYNOTE-426 support pembrolizumab plus axitinib as the standard of care for advanced clear cell renal cell carcinoma."

Journal • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Real-world effectiveness and safety of first-line (1L) avelumab + axitinib (ave + axi) in patients with advanced renal cell carcinoma (aRCC): Final analysis of the prospective AVION study. (ASCO-GU 2026) - P | "Background: In the JAVELIN Renal 101 phase 3 trial, 1L Ave + Axi significantly prolonged progression-free survival (PFS) and increased the objective response rate (ORR) vs sunitinib in patients with aRCC, with an acceptable safety profile. The final analysis of AVION confirms the real-world effectiveness, acceptable safety, and favorable tolerability with maintained HRQOL of 1L Ave + Axi treatment in a heterogeneous real-world population with aRCC in Europe, consistent with earlier results and previous studies."

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

A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naïve, cisplatin-ineligible urothelial cancer. (PubMed, ESMO Open) - P2 | "In previously treated patients with advanced/metastatic NSCLC, ORR appeared to be superior to anti-PD-L1 or anti-programmed cell death protein 1 monotherapy, irrespective of PD-L1 status, whereas in untreated, cisplatin-ineligible patients with advanced/metastatic UC, ORR was lower than expected, potentially limited by small patient numbers."

IO biomarker • Journal • P2 data • Tumor mutational burden • Genito-urinary Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8 • TMB

Using liquid biopsies to classify adenoid cystic carcinoma into clinically relevant subtypes (ESMO 2025) - P2 | "Methods We profiled the specimens from twenty-two ACC patients enrolled in a clinical trial assessing the efficacy of axitinib plus avelumab (NCT03990571). Conclusions Subtyping of ACC is feasible not only from tissue but also from liquid biopsies, allowing minimal invasive and longitudinal analysis of subtypes. This novel method might enable further personalized trials in ACC."

Biopsy • Clinical • Liquid biopsy • Adenoid Cystic Carcinoma • Oncology • NOTCH1 • TP63

Sarcomatoid Renal Cell Carcinoma: A Clinical Review. (PubMed, Diagnostics (Basel)) - P3 | "Adjuvant pembrolizumab significantly improved disease-free survival in high-risk localised RCC with sarcomatoid features (KEYNOTE-564; NCT03142334). In the metastatic setting, nivolumab plus ipilimumab and pembrolizumab plus axitinib are preferred first-line regimens."

IO biomarker • Journal • Review • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • BAP1 • CD8 • CDKN2A • CDKN2B • PAX8 • PD-L1 • TP53 • VIM

Extended follow-up from JAVELIN Renal 101: subgroup analysis of avelumab plus axitinib versus sunitinib by the International Metastatic Renal Cell Carcinoma Database Consortium risk group in patients with advanced renal cell carcinoma. (PubMed, ESMO Open) - P3 | "Avelumab plus axitinib continues to show improved efficacy versus sunitinib and a tolerable safety profile overall and across IMDC risk groups. The OS trend favors avelumab plus axitinib versus sunitinib, but data remain immature; follow-up is ongoing."

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

Phase II Clinical Trial of Neoadjuvant anti-PD-1 (Toripalimab) Combined with Axitinib in Resectable Mucosal Melanoma. (PubMed, Ann Oncol) - P2 | "Neoadjuvant toripalimab combined with axitinib in resectable mucosal melanoma demonstrated a promising pathologic response rate with significantly increased infiltrating CD3+ and CD3+CD8+ T cells after therapy."

Journal • P2 data • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • CD8

Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma. (PubMed, Eur Urol) - P3 | "Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS."

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

Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): Results from phase III part of a randomized, open-label, active-controlled phase II/III study (FRUSICA-2) (ESMO 2025) - P2/3 | "The incidences of grade ≥3 TEAEs (71.4% vs 58.8%), TEAEs leading to treatment discontinuation (17.6% vs 9.6%), and fatal TEAEs (4.2% vs 4.4%) were comparable between groups. Table: 2592MO Efficacy Results by IMDC Prognostic Risk ITT set (BIRC-assessed) IMDC risk factor Number of IMDC risk factor Favorable-risk Intermediate-risk Poor-risk 0-1 risk factors FRUQ+ SIN N=33 AXI/EVE N=32 FRUQ+ SIN N=73 AXI/EVE N=72 FRUQ+ SIN N=13 AXI/EVE N=11 FRUQ+ SIN N=76 AXI/EVE N=73 mPFS, months NR 8.31 22.21 6.97 9.69 4.21 24.87 8.31 Unstratified HR (95% CI) 0.270 (0.117, 0.620) 0.352 (0.221, 0.562) 0.591 (0.203, 1.721) 0.278 (0.168, 0.461) Unstratified log-rank p * 0.0009 <0.0001 0.3267 <0.0001 ORR (%) 63.6 25.0 61.6 23.6 46.2 27.3 63.2 26.0 Odds ratio (95% CI) 5.250 (1.608, 17.712) 5.200 (2.394, 11.435) 2.286 (0.315, 19.098) 4.872 (2.292, 10.456) p * 0.0019 <0.0001 0.3514 <0.0001 *Two-sided Conclusions FRUQ+SIN demonstrated superior mPFS and manageable safety compared..."

Clinical • Metastases • Monotherapy • P2/3 data • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A randomized phase II study of axitinib plus toripalimab with or without local therapy in patients with locoregional recurrent renal cell carcinoma (ESMO 2026) - No abstract available

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

Global circulating free DNA methylation and fragmentome deconvolution in patients with metastatic renal cell carcinoma treated with immunotherapy (GOLDEN). (ASCO 2023) - P=N/A | "20/33 (61%) patients received ipilimumab/nivolumab, 10/33 (30%) nivolumab and n=3/33 (9%) pembrolizumab/axitinib. This small study is the first report on the role of cfMeDIPseq-derived methylation and fragmentomic signatures in patients with mRCC undergoing ICI-based treatment. We found several trends and one significant association between these signatures and pt outcomes, which support further validation in larger cohorts. Clinical trial information: NCT03702309."

Clinical • Epigenetic controller • IO biomarker • Metastases • Genito-urinary Cancer • Immune Modulation • Oncology • Renal Cell Carcinoma • Solid Tumor

Integrative Analyses of Tumor and Peripheral Biomarkers in the Treatment of Advanced Renal Cell Carcinoma. (PubMed, Cancer Discov) - "We provide evidence for different immunomodulatory mechanisms based on treatment (A+Ax vs. sunitinib) and tumor molecular subtypes. Our findings provide novel insights into the different immunomodulatory mechanisms governing responses in patients treated with avelumab (PD-L1 inhibitor) + axitinib or sunitinib (both VEGF inhibitors), highlighting the contribution of tumor biology to the complexity of the roles and interactions of infiltrating immune cells in response to these treatment regimens."

Biomarker • IO biomarker • Journal • Metastases • Genito-urinary Cancer • Oncology • 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

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Jun 2028 ➔ Jun 2033

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

Axitinib plus avelumab in patients with unresectable/metastatic gastrointestinal stromal tumor (GIST) after failure of standard therapy: Single-arm phase II study (AXAGIST) (ESMO 2024) - P2 | "The results of this largest trial of combination of targeted therapy and immunotherapy in pretreated GIST shows significant efficacy of this novel therapeutic approach. A substantial subset of pts achieved long-term clinical benefit. Further correlations of biomarkers will be presented."

Clinical • IO biomarker • Metastases • P2 data • Stroma • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Avelumab plus axitinib in unresectable or metastatic type B3 thymomas and thymic carcinomas (CAVEATT): a single-arm, multicentre, phase 2 trial. (PubMed, Lancet Oncol) - "Avelumab combined with axitinib has promising anti-tumour activity and acceptable toxicity in patients with advanced type B3 thymoma and thymic carcinoma progressing after chemotherapy, and could emerge as a new standard treatment option in this setting."

Journal • P2 data • Cardiovascular • Hypertension • Immune Modulation • Immunology • Inflammation • Interstitial Lung Disease • Myositis • Oncology • Pneumonia • Solid Tumor • Thymic Carcinoma • Thymoma • Thymus Cancer

Axitinib and Long-Acting Octreotide in Advanced Extrapancreatic Neuroendocrine Tumors: A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial (AXINET, GETNE 1107). (PubMed, J Clin Oncol) - "Axitinib significantly increased PFS per BICR assessment and ORR both per investigator and BICR assessment compared with placebo, although the primary study end point was not met. Toxicity profile was manageable with no new safety concerns."

Clinical • Journal • P3 data • Cardiovascular • Gastrointestinal Neuroendocrine Tumor • Hypertension • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

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