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CLINICAL TRIALS PROFILE FOR FOTIVDA

All Clinical Trials for fotivda

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03970616 ↗	A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Recruiting	AstraZeneca	Phase 1/Phase 2	2019-09-30	This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
NCT03970616 ↗	A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Recruiting	AVEO Pharmaceuticals, Inc.	Phase 1/Phase 2	2019-09-30	This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
NCT05000294 ↗	Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types	Recruiting	Aveo Oncology Pharmaceuticals	Phase 1/Phase 2	2021-10-01	Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.
NCT05000294 ↗	Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types	Recruiting	Genentech, Inc.	Phase 1/Phase 2	2021-10-01	Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

Clinical Trial Conditions for fotivda

Condition Name

Condition Name for fotivda
Intervention	Trials
Gall Bladder Cancer	1
Hepatocellular Carcinoma	1
Neuroendocrine Tumors	1
Ovarian Cancer	1

Condition MeSH

Condition MeSH for fotivda
Intervention	Trials
Adenocarcinoma	1
Prostatic Neoplasms	1
Carcinoma, Hepatocellular	1
Ovarian Neoplasms	1

Clinical Trial Locations for fotivda

Trials by Country

Trials by Country for fotivda
Location	Trials
United States	8

Trials by US State

Trials by US State for fotivda
Location	Trials
Florida	1
Washington	1
Texas	1
New York	1
Massachusetts	1

Clinical Trial Progress for fotivda

Clinical Trial Phase

Clinical Trial Phase for fotivda
Clinical Trial Phase	Trials
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for fotivda
Clinical Trial Phase	Trials
Recruiting	2

Clinical Trial Sponsors for fotivda

Sponsor Name

Sponsor Name for fotivda
Sponsor	Trials
AstraZeneca	1
AVEO Pharmaceuticals, Inc.	1
Aveo Oncology Pharmaceuticals	1

Sponsor Type

Sponsor Type for fotivda
Sponsor	Trials
Industry	3
Other	2

Fotivda Market Analysis and Financial Projection

Clinical Trials Update, Market Analysis, and Projections for FOTIVDA

Introduction to FOTIVDA

FOTIVDA, also known as tivozanib, is an orally available next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is specifically designed to target VEGFR-1, -2, and -3, inhibiting the formation of blood vessels that nourish tumors and interfering with tumor growth and vascular permeability[1][4][5].

FDA Approval and Current Indications

In March 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. This approval was based on the positive results of the TIVO-3 clinical trial, which compared FOTIVDA to sorafenib (Nexavar)[2][5].

TIVO-3 Clinical Trial

The TIVO-3 trial was a pivotal Phase 3 study that demonstrated FOTIVDA's efficacy in the third-line setting. The trial showed that FOTIVDA prolonged median progression-free survival (PFS) to 5.6 months, compared to 3.9 months for Nexavar. Additionally, 18% of patients treated with FOTIVDA achieved a pre-specified response to treatment, compared to 8% for those treated with Nexavar. Although FOTIVDA did not show a significant improvement in overall survival, its safety profile and tolerability were highlighted as key benefits[2][5].

TiNivo-2 Clinical Trial

The TiNivo-2 trial was a Phase 3 study designed to evaluate the safety and efficacy of FOTIVDA in combination with nivolumab (Opdivo) compared to FOTIVDA monotherapy in RCC patients whose tumors had progressed following prior immune checkpoint inhibitor (ICI) therapy. The trial did not meet its primary efficacy endpoint, as the combination of FOTIVDA and nivolumab did not significantly prolong PFS compared to FOTIVDA alone. However, the control arm data showed a "clinically meaningful" improvement in median PFS for patients receiving FOTIVDA monotherapy in the second-line setting, further supporting its approved use[1][4].

Market Analysis

Competitive Landscape

The renal cell carcinoma (RCC) treatment landscape is highly competitive, with several drugs approved for various lines of therapy. FOTIVDA's approval in the third-line setting fills a specific niche, particularly for patients who have received two or more prior systemic therapies. Its safety and tolerability profile, as well as its selective inhibition of VEGFRs, position it as a viable option in this setting[2][5].

Commercial Performance

Following its FDA approval, AVEO Oncology launched FOTIVDA with a wholesale list price of $24,150 per month. The company has projected peak sales of $417 million, driven by its unique positioning in the third-line RCC market. The drug's commercial success will depend on its ability to carve out a meaningful niche and demonstrate its value to clinicians and patients[2].

Market Projections

Given its approval and the growing need for well-tolerated treatment options in the relapsed or refractory RCC setting, FOTIVDA is expected to play a significant role in the evolving RCC treatment landscape. Analysts project that FOTIVDA will achieve substantial sales, particularly as it becomes more established as a safe and effective treatment option for patients who have exhausted other therapies[2].

Safety and Tolerability

FOTIVDA's safety profile has been a key factor in its approval and market positioning. The drug is generally safer and more tolerable than other TKIs, such as Nexavar. Common adverse events include hypertension, which was reported in 45% of FOTIVDA-treated patients, with 22% of these events being Grade 3 or higher. Hypertensive crises were reported in 0.8% of patients[4].

Future Clinical Trials and Combinations

AVEO Oncology is continuing to explore the potential of FOTIVDA in various combinations and indications. For example, the Phase 1b/2 DEDUCTIVE study is investigating FOTIVDA in combination with durvalumab (IMFINZI) in previously untreated metastatic hepatocellular carcinoma (HCC). These studies aim to expand the therapeutic utility of FOTIVDA and potentially move it into earlier lines of treatment or other cancer types[3].

Expert Insights

According to Brian Rini, MD, chief of clinical trials at Vanderbilt Ingram Cancer Center and principal investigator of the TIVO-3 trial, "FOTIVDA represents an attractive intervention, and I expect it to play a meaningful role in the evolving RCC treatment landscape." This sentiment is echoed by AVEO's CEO, Michael Bailey, who highlighted the importance of the control arm data from the TiNivo-2 trial in supporting FOTIVDA's use in relapsed or refractory RCC patients[1][5].

Key Takeaways

• FDA Approval: FOTIVDA is approved for the treatment of adult patients with relapsed or refractory advanced RCC who have received two or more prior systemic therapies.
• Clinical Trials: The TIVO-3 trial demonstrated FOTIVDA's efficacy in the third-line setting, while the TiNivo-2 trial showed no significant benefit from adding nivolumab to FOTIVDA.
• Market Positioning: FOTIVDA fills a specific niche in the RCC treatment landscape with its safety and tolerability profile.
• Commercial Projections: Projected peak sales of $417 million driven by its unique positioning.
• Future Directions: Ongoing and planned clinical trials aim to expand FOTIVDA's therapeutic utility.

FAQs

What is FOTIVDA and how does it work?

FOTIVDA (tivozanib) is an oral next-generation VEGFR TKI that selectively inhibits VEGFR-1, -2, and -3, preventing tumor growth and vascular permeability.

What is the current FDA-approved indication for FOTIVDA?

FOTIVDA is approved for the treatment of adult patients with relapsed or refractory advanced RCC who have received two or more prior systemic therapies.

What were the results of the TiNivo-2 clinical trial?

The TiNivo-2 trial did not meet its primary efficacy endpoint, as the combination of FOTIVDA and nivolumab did not significantly prolong PFS compared to FOTIVDA alone. However, the control arm data showed a clinically meaningful improvement in median PFS for patients receiving FOTIVDA monotherapy.

How does FOTIVDA compare to other RCC treatments in terms of safety and tolerability?

FOTIVDA is generally safer and more tolerable than other TKIs, such as Nexavar, with a lower incidence of severe adverse events.

What are the future clinical trial plans for FOTIVDA?

AVEO Oncology is exploring FOTIVDA in various combinations and indications, including a Phase 1b/2 study in combination with durvalumab in previously untreated metastatic HCC.

What is the projected market performance of FOTIVDA?

FOTIVDA is projected to achieve peak sales of $417 million, driven by its unique positioning in the third-line RCC market.

Sources

1. Biospace: AVEO's Fotivda Combo Flunks Phase III Renal Cell Carcinoma Study
2. FiercePharma: Aveo's tivozanib, now approved as Fotivda, will hit the market after years of setbacks
3. AVEO Oncology: AVEO Oncology Announces Results from Phase 1b Portion of DEDUCTIVE Study of Tivozanib (FOTIVDA) in Combination with IMFINZI (durvalumab)
4. PR Newswire: AVEO Oncology, an LG Chem company, Announces Phase 3 Renal Cell Carcinoma Clinical Trial TiNivo-2 Results
5. Cancer Network: Tivozanib Receives Full Approval for Treatment of Patients With Third-Line or Later RCC