Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem, Recordati - LARVOL DELTA

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

TIVOZANIB-INDUCED PULMONARY HYPERTENSION (CHEST 2026) - No abstract available

Cardiovascular • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Patient-reported outcomes (PROs) for tivozanib (TIVO) + nivolumab (NIVO) vs TIVO monotherapy in patients with renal cell carcinoma (RCC) following an immune checkpoint inhibitor (ICI): Results of the phase 3 TiNivo-2 study. (ASCO-GU 2025) - P3 | "There were no differences in the PRO outcomes between the combination therapy and monotherapy arms or between the 2 different TIVO doses. PRO data suggested that TIVO maintained the FKSI-DRS and EORTC QLQ-C30 mean scores from BL to week 24. In the TIVO arm, the proportion of patients who had improvement in FKSI-DRS and EORTC QLQ-C30 scores was numerically better in patients receiving 2L vs 3L treatment, while the portion of patients with a deterioration was smaller in the 2L than in the 3L."

Checkpoint inhibition • Clinical • Monotherapy • P3 data • Patient reported outcomes • Genito-urinary Cancer • Oncology • Solid Tumor

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

Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study. (PubMed, Lancet) - P3 | "These data further support that ICI rechallenge should be discouraged in patients with advanced renal cell carcinoma. Furthermore, these data suggest that tivozanib monotherapy has efficacy in the post-ICI setting."

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

Activity of Tivozanib in Non-clear Cell Renal Cell Carcinoma: Subgroup Analysis From a Phase II Randomized Discontinuation Trial. (PubMed, Oncologist) - P2 | "Tivozanib demonstrated activity and a favorable safety profile in patients with nccRCC. These data add to the body of evidence supporting the use of VEGFR-TKI in advanced nccRCC."

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

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for Hogh-Risk Renal Cell Carcinoma – STRIKE! (A033201) -NCT06661720 (KCRS 2025) - P3 | "is the first trial and only trial to explore the role of adding a VEGF TKI to immunotherapy in the adjuvant setting for resected high risk ccRCC. Correlative analysis will be essential to develop-ment of biomarkers of minimal residual disease and response to therapy."

IO biomarker • Clear Cell Renal Cell Carcinoma • Fatigue • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor

Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): Results of the phase III TiNivo-2 study (ESMO 2024) - P3 | "ICI combination rechallenge did not improve clinical outcomes, suggesting the avoidance of sequential ICI in advanced RCC outside of clinical trials. These results support tivozanib monotherapy at 1.34 mg daily as 2nd-line therapy for pts following progression on previous ICI combination therapy."

Checkpoint inhibition • Clinical • Late-breaking abstract • Monotherapy • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Short term intensified pembrolizumab and tivozanib for high-risk renal cell carcinoma: STRIKE! (Alliance A032201). (ASCO-GU 2026) - P3 | "Imaging and specimens will be banked for future research. The study opened to accrual in April 2025 and at this time 106 patients have enrolled."

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

Temporal Characteristics of Adverse Events of Tivozanib and Sorafenib in Previously Treated Kidney Cancer. (PubMed, Clin Genitourin Cancer) - "Tivozanib was associated with less TRAEs, fewer dose modifications, a longer time to onset and a shorter duration of TRAEs compared to sorafenib."

Adverse events • Journal • Genito-urinary Cancer • Immunology • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Activity of tivozanib in non-clear cell renal cell carcinoma (nccRCC): Subgroup analysis from a phase 2 randomized discontinuation trial. (ASCO 2022) - P2 | "Tivozanib demonstrated activity and a favorable safety profile in patients with nccRCC. This data adds to the body of evidence supporting VEGFR TKI use in advanced RCC including in non-clear cell histologies."

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

Final analysis of the TiNivo-2 phase 3 trial: Long-term outcome of tivozanib (Tivo) in patients with metastatic renal cell carcinoma (mRCC). (ASCO 2026) - P3 | " TiNivo-2 trial design and primary-endpoint results were previously reported: patients with mRCC were randomized to treatment with Tivo 0.89 mg once daily for 21/28 days plus Nivolumab (Nivo) at 480 mg every four weeks (Tivo/Nivo) or Tivo 1.34 mg once daily for 21/28 days. This final analysis of patients in the TiNivo-2 study highlights the sustained efficacy Tivo in mRCC with a consistent safety profile. Together, these findings support durable clinical benefit and tolerability of Tivo in the post-ICI treatment setting in RCC, an area of high unmet need (NCT04987203). NR, not reached."

Clinical • Metastases • P3 data • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Renal Cell Carcinoma • Solid Tumor

Development and Validation of an LC-MS/MS Method for Simultaneous Quantification of Pazopanib, Cabozantinib, Sorafenib, Axitinib, Tivozanib, Sunitinib, and the Metabolites Sorafenib N-Oxide and Desethyl-Sunitinib in Human Plasma. (PubMed, Pharmaceuticals (Basel)) - " We established and validated a fast, sensitive, and accurate LC-MS/MS method enabling simultaneous quantification of six TKIs and two metabolites in human plasma. The analytical method was successfully applied to plasma samples from patients in treatment with the six TKIs, demonstrating proof of concept for its application in TDM."

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

Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC). (ASCO-GU 2025) - P3 | "The efficacy ER models predicted that TIVO 1.34 mg would provide greater antitumor activity than the 0.89-mg dose, while the predicted HTN incidence (any grade and grade ≥3) was comparable at the 0.89- and 1.34-mg doses. The TIVO monotherapy dose selection of 1.34 mg is important, based on the ER analysis and its safety profile. The results from the TiNivo-2 data set further confirmed that re-challenge with immunotherapy does not add benefit and optimal dosing of TKI provides the highest clinical benefit."

Clinical • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy of second line (2L) treatment with tivozanib (Tivo) as monotherapy or with nivolumab (Nivo) in patients (pts) with metastatic renal cell carcinoma (mRCC) previously treated with an immune checkpoint inhibitor (ICI) combination of ipilimumab (Ipi)/Nivo or vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI)/ICI in the phase 3 TiNivo-2 study. (ASCO 2025) - P3 | " Among the 153 eligible 2L pts, 70 (46%) previously received Ipi/Nivo and 83 (54%) previously received a VEGFR-TKI/ICI regimen (TKI/ICI): axitinib/pembrolizumab (54.2%), cabozantinib/nivolumab (25.3%), axitinib/avelumab (12.0%), and lenvatinib/pembrolizumab (8.4%)... In this TiNivo-2 subgroup analysis, Tivo monotherapy at 1.34 mg daily showed activity in pts who previously received a contemporary 1L mRCC regimen. At this dose of Tivo, substantial tumor size reduction was observed, both after Ipi/Nivo and VEGFR-TKI/ICI regimens. There appeared to be no benefit with the addition of Nivo to Tivo in this context, akin to the results of the parent trial."

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

Real-world efficacy of nivolumab plus cabozantinib in metastatic renal cell carcinoma (mRCC) using the IMDC. (ASCO-GU 2026) - "The most commonly used second line drugs were Axitinib (27.6%) and Lenvatinib plus Everolimus (17.2%). Others included Sunitinib (6.9%), Pazopanib (6.9%), Tivozanib (6.9%), Pembrolizumab plus Lenvatinib (5.2%) and Belzutifan (3.4%)... In this real-world analysis, Nivolumab plus Cabozantinib achieved TTNT and OS comparable to those reported in CheckMate 9ER, albeit with a somewhat lower ORR (41.6% vs 55.7%), likely influenced by the inclusion of non-clear cell histology. Importantly, 2nd line TKIs demonstrated activity following Cabozantinib exposure, supporting its use in this treatment sequence. Baseline characteristics."

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

Efficacy, safety, and tolerability of tivozanib (TIVO) in heavily pretreated patients (pts) with advanced clear-cell renal cell carcinoma (ccRCC). (ASCO-GU 2024) - "Background: TIVO, a potent tyrosine kinase inhibitor that predominantly targets vascular endothelial growth factor receptors, is approved as a third or later line therapy for advanced RCC based on improved progression-free survival (PFS) compared with sorafenib in the TIVO-3 trial. However, TIVO-3 was conducted before immune checkpoint-based therapies (ICT), cabozantinib (CABO), and lenvatinib/everolimus (LEN/EVE) became fully incorporated in the sequential treatment paradigm for advanced ccRCC...All pts received prior ICT (30% nivolumab/ipilimumab), 40% received prior axitinib, 87% CABO and 60% LEN +/- EVE... In this cohort of heavily pretreated pts with advanced ccRCC, TIVO yielded a modest clinical benefit in a minority of pts who received prior ICT, CABO, and LEN +/- EVE. TRAEs observed with TIVO were consistent with previously published reports."

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

VHL and TP53 mutation status are not associated with response or progression-free survival in metastatic renal cell carcinoma treated with VEGF-targeted therapies (KCRS 2025) - "VEGF-targeted therapy was defined broadly to include newer generation vascular endothelial growth factor tyrosine kinase inhibitors (VEGF-TKIs; excluding agents like sunitinib), belzutifan, and VEGF-TKI–based combinations with immunotherapy or everolimus...The most common VEGF-targeted therapies were cabozantinib, lenvatinib, axitinib, and tivozanib, frequently administered in combination with immunotherapy or everolimus...Conclusions In this ctDNA-based analysis of patients with mRCC treated with VEGF-targeted therapies, neither VHL nor TP53 mutation status was associated with meaningful differences in clinical outcomes. These findings align with prior reports and suggest that mutation status alone may not predict efficacy of VEGF-targeted regimens, even in the context of combination therapies."

IO biomarker • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • TP53 • VEGFA • VHL

Real-world Effectiveness of Single-Agent Tivozanib in Patients with Metastatic Clear Cell Renal Cell Carcinoma. (PubMed, J Kidney Cancer VHL) - "In summary, single-agent tivozanib potentially provides clinically meaningful benefits in heavily pretreated patients with mccRCC. These findings support its role as a useful later-line therapeutic option in mccRCC management."

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

A phase Ib/II study of atezolizumab plus tivozanib in pancreatic, gallbladder, and bile duct malignancies. (ASCO-GI 2024) - P1/2 | "Treatment will continue until progression or intolerance. Clinical trial information: NCT05000294."

P1/2 data • Tumor mutational burden • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • CD4 • CD8 • HER-2 • MSI • TMB

Tivozanib versus Sorafenib as Subsequent-Line Therapy for Advanced Renal Cell Carcinoma: A Cost-Effectiveness Analysis from a US Healthcare Perspective. (PubMed, Risk Manag Healthc Policy) - "The high ICER is primarily driven by substantial drug costs relative to modest incremental health gains. Substantial price reductions are necessary to improve its value proposition within the US healthcare system."

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

Real-World Outcomes and Clinicogenomic Factors Associated with Response to Tivozanib: A Multi-Center Study (KCRS 2026) - "There were no significant associations between clinicogenomic factors and outcomes, underscoring the need to identify novel biomarkers for mRCC. Keywords Renal Cell Carcinoma, Tivozanib"

Clinical • Real-world • Real-world evidence • Genito-urinary Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • CDKN2A • CDKN2B • NF1 • PBRM1 • SETD2 • TP53

Final Analysis of the TiNivo-2 Phase 3 Trial: Long-term Outcome of Tivozanib (Tivo) in Patients with Metastatic Renal Cell Carcinoma (mRCC) (KCRS 2026) - P3 | "Methods TiNivo-2 trial design and primary-endpoint results were previously reported: patients with mRCC were randomized to treatment with reduced dose Tivo 0.89 mg once daily for 21/28 days plus Nivolumab (Nivo) at 480 mg every four weeks (Tivo/Nivo) or standard dose Tivo 1.34 mg once daily for 21/28 days. Together, these findings support benefit and tolerability of standard dose (1.34mg) Tivo monotherapy in the post-ICI treatment setting in RCC, an area of high unmet need. (NCT04987203) Keywords mRCC; long-term follow up; Tivozanib; safety"

Clinical • Metastases • P3 data • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Renal Cell Carcinoma • Solid Tumor

Preclinical Ocular Pharmacokinetics and Efficacy of Novel Tivozanib Eye Drops for Neovascular Age-Related Macular Degeneration. (PubMed, Invest Ophthalmol Vis Sci) - "In the monkey CNV model, nTivo eye drops significantly reduced the neovascularization lesion area. The nTivo eye drop formulation may be a potential new treatment option for nAMD due to its preferable ocular pharmacokinetic and anti-angiogenic profiles based on potential contributions of nanocrystallization and the melanin binding properties of tivozanib."

Journal • PK/PD data • Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Posterior reversible encephalopathy syndrome across 22 VEGF-pathway inhibitors in the FDA adverse event reporting system: reporting patterns and reporting-interval characteristics. (PubMed, Front Pharmacol) - "Signal intensity separated cleanly by VEGFR-2 selectivity: every highly selective VEGFR-TKI (tivozanib, lenvatinib, fruquintinib, axitinib; ROR 9.74-16.68) ranked above every multi-kinase agent (ROR 2.00-6.05) (Mann-Whitney p = 0.005; Spearman rho = 0.84, p = 0.001)...Nintedanib yielded an inverse signal (ROR 0.34), likely indication channelling...IC50-based analyses were small-sample and hypothesis-generating only. Tivozanib and ramucirumab emerged as under-represented signals meriting confirmation; selective VEGFR-TKI recipients may warrant close blood-pressure monitoring and a low threshold for neuroimaging."

Adverse events • Journal • CNS Disorders • KDR