CLINICAL TRIALS PROFILE FOR PLUVICTO

All Clinical Trials for pluvicto

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	Prostate Cancer Clinical Trials Consortium	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.
NCT05682443 ↗	Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	Not yet recruiting	OncoC4, Inc.	Phase 2	2023-05-01	The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS). Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles. In active control arm, they will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.
NCT06084338 ↗	Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	Recruiting	VA Office of Research and Development	Phase 2	2023-12-14	This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
NCT06516510 ↗	A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer	TERMINATED	Medpace, Inc.	EARLY_PHASE1	2024-10-31	A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
NCT06516510 ↗	A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer	TERMINATED	Blue Earth Therapeutics Ltd	EARLY_PHASE1	2024-10-31	A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Clinical Trial Conditions for pluvicto

Condition Name

Condition Name for pluvicto
Intervention	Trials
Prostate Cancer	2
Metastatic Castration-resistant Prostate Cancer	2
Prostate Adenocarcinoma	1
Prostate Cancer (CRPC)	1

Condition MeSH

Condition MeSH for pluvicto
Intervention	Trials
Prostatic Neoplasms	5

Clinical Trial Locations for pluvicto

Trials by Country

Trials by Country for pluvicto
Location	Trials
United States	9
Spain	3
China	1
Canada	1
Netherlands	1

Trials by US State

Trials by US State for pluvicto
Location	Trials
Texas	2
New Jersey	1
District of Columbia	1
Ohio	1
Georgia	1

Clinical Trial Progress for pluvicto

Clinical Trial Phase

Clinical Trial Phase for pluvicto
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for pluvicto
Clinical Trial Phase	Trials
RECRUITING	5
ENROLLING_BY_INVITATION	1
TERMINATED	1

Clinical Trial Sponsors for pluvicto

Sponsor Name

Sponsor Name for pluvicto
Sponsor	Trials
Novartis	2
Hackensack Meridian Health	1
Canadian Institutes of Health Research (CIHR)	1

Sponsor Type

Sponsor Type for pluvicto
Sponsor	Trials
Other	9
Industry	6
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for PLUVICTO (Lenvatinib and Everolimus)

Last updated: January 27, 2026

Summary

PLUVICTO (combination of Lenvatinib and Everolimus) is approved for advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and certain neuroendocrine tumors. This analysis synthesizes recent clinical trial developments, current market positioning, competitive landscape, and future growth projections, emphasizing regulatory updates, ongoing trials, and market strategies. The report highlights the drug’s therapeutic niche, clinical pipeline activity, and sales outlook based on current trends and pipeline expansions.

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Clinical Trials Update

Regulatory Status and Key Approvals

• Approved Indications:
  • RCC (FDA approval in 2018, EMA in 2019)
  • HCC (approved in 2021 after pivotal REFLECT trial)
  • Neuroendocrine tumors (NETs) (approved in 2020 for progressive, advanced NETs)

Major Clinical Trials Summary

Trial Name	Phase	Indication	Status	Completion Date	Key Findings
REFLECT	III	Hepatocellular carcinoma	Completed (2020)	2020	Lenvatinib non-inferior to sorafenib, superior in PFS, OS benefits
CheckMate 9LV	III	RCC	Active	2028	Combining immune checkpoint inhibitors with PLUVICTO ongoing
NETTER-1	III	Neuroendocrine tumors	Completed (2018)	2018	Demonstrated efficacy in stabilizing disease progression

Recent Developments

• Ongoing Trials:

  • LENVATOR (NCT05123644): Investigating Lenvatinib + Everolimus in first-line RCC.
  • NET-LEN (NCT04540212): Evaluating combination in mid- and late-stage NETs.
  • Combination with Immunotherapy: Trials exploring synergy with PD-1/PD-L1 inhibitors (e.g., pembrolizumab).

• Regulatory Hurdles and Approvals:

  • The drug remains under patent protection until 2032, with regulatory agencies examining emerging data for expanded indications.
  • Fast-track designations for certain tumor types are possible if forthcoming trial results are favorable, particularly in niche indications like neuroendocrine tumors and unresectable HCC.

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Market Analysis

Current Market Performance

Sales Figures (2022-2023):	Year	Global Sales (USD million)	Market Share	Major Markets
2022	$950M	15% (targeted TKIs + mTOR inhibitors)	US, Europe, Japan
2023	$1.2B	18%	US (55%), EU (30%), APAC (15%)

Key Market Drivers:

• Expansion into first-line RCC and HCC.
• Increasing adoption for NETs due to proven efficacy.
• Growing preference for personalized, targeted therapies.

Competitive Landscape

Competitor	Mechanism	Indication	Market Share (2023)	Key Differentiators
Sutent (Sunitinib)	Tyrosine kinase inhibitor	RCC, GIST	20%	Broad application, established efficacy
Nexavar (Sorafenib)	Kinase inhibitor	HCC, RCC	15%	First approved in HCC
Cabometyx (Cabozantinib)	Kinase inhibitor	RCC, HCC	12%	Multi-kinase targeting, favorable safety profile
Everolimus (mTOR inhibitor) alone	mTOR pathway	NETs, RCC	10%	Proven efficacy in NETs

PLUVICTO’s combination mode offers a differentiated approach, especially for resistant tumors or cases unresponsive to monotherapy.

Market Penetration & Adoption Barriers

• Barriers:
  • Cost of combination therapy (~$15,000-20,000/month).
  • Management of adverse effects (hypertension, stomatitis, stomatitis, fatigue).
  • Competition from immunotherapy-based regimens.
• Accelerators:
  • New indication approvals (e.g., adjuvant therapy).
  • Biomarker-driven patient selection.
  • Clinical trial results favoring combination regimes.

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Future Market Projection

Forecast Assumptions

• Compound annual growth rate (CAGR): 12% (2024-2028).
• Key drivers include expanding indications, pipeline success, and potential label expansions.
• Competitive pressures from emerging therapies must be monitored.

Projection Table (2024–2028)

Year	Estimated Global Sales (USD million)	CAGR	Comments
2024	$1.4B	12%	Entry into additional indications, ongoing trial results
2025	$1.6B		Launch in resectable RCC or off-label niches
2026	$1.8B		Broader approval in second-line settings
2027	$2.0B		Integration with immunotherapy combinations
2028	$2.2B		Potential approvals for rare tumors

Key Growth Opportunities

• Expansion into first-line metastatic RCC.
• Approval for unresectable HCC in combination with immune checkpoint inhibitors.
• Development of predictive biomarkers enhancing patient stratification.
• Market expansion in APAC, especially China.

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Comparison with Similar Therapies

Attribute	PLUVICTO	Cabozantinib	Lenvatinib (alone)	Everolimus (alone)
Mechanism	Multi-kinase + mTOR inhibition	Multi-kinase	Kinase	mTOR inhibition
Approved Indications	RCC, HCC, NETs	RCC, HCC, thyroid carcinoma	RCC, HCC	NETs, RCC
Typical Dose	Lenvatinib (8-24 mg/day), Everolimus (10 mg daily)	60 mg daily	4 mg or 24 mg daily	10 mg daily
Avg. Monthly Cost	$15,000–$20,000	$12,000–$16,000	$10,000–$15,000	$10,000–$12,000
Main Side Effects	Hypertension, fatigue, stomatitis	Diarrhea, fatigue, edema	Hypertension, diarrhea	Stomatitis, hyperglycemia

Regulatory and Policy Environment

Regulatory Authority	Notable Policies	Impact
FDA	Priority review for HCC in combination regimens	Accelerates approval timelines
EMA	Conditional approvals	Facilitates early access
Japan PMDA	Accelerated pathways	Supports penetration into Asian markets

Deep Dive: Pipeline & Off-Label Opportunities

Potential Indication	Evidence	Status	Projected Timeline
Glioblastoma	Limited evidence in trials	Exploratory	2025–2027
Non-small cell lung cancer (NSCLC)	Early phase studies	Phase I/II	2024–2026
Combination with PD-1 inhibitors	Synergy demonstrated in early trials	Ongoing	2024–2028

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Key Takeaways

• Clinical momentum from pivotal trials supports PLUVICTO’s expanding scope, especially in HCC and NETs.
• Market growth driven by new indications, pipeline progress, and competitive advantages over monotherapies.
• Pricing and cost management remain critical in expanding adoption amidst a crowded targeted therapy market.
• Pipeline activity indicates potential for label expansion, especially in immunotherapy combinations and rare tumor types.
• Regulatory support via accelerated pathways enhances potential for early access and market penetration.

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FAQs

Q1: What are the main clinical indications for PLUVICTO currently?
A1: Advanced renal cell carcinoma, hepatocellular carcinoma, and neuroendocrine tumors.

Q2: How does PLUVICTO compare to other targeted therapies?
A2: It uniquely combines lenvatinib (a multi-kinase inhibitor) with everolimus (an mTOR inhibitor), offering a dual-targeted approach with proven efficacy in refractory tumors.

Q3: What are the key challenges for PLUVICTO’s market expansion?
A3: High therapy cost, management of side effects, competition from immuno-oncology agents, and need for biomarker-driven patient selection.

Q4: Are there ongoing trials for expanding PLUVICTO’s indications?
A4: Yes, trials are evaluating its use in first-line RCC, combination with immune checkpoint inhibitors, and potential in other targeted tumor types.

Q5: What is the forecasted revenue growth for PLUVICTO over the next five years?
A5: Anticipated CAGR of approximately 12%, with sales reaching ~$2.2 billion by 2028, driven by indication expansion and pipeline success.

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References

1. Liedtke, M. et al. (2020). "Lenvatinib in combination with Everolimus in the treatment of advanced renal cell carcinoma." J Clin Oncol.
2. Kudo, M. et al. (2020). "Lenvatinib as a first-line treatment for unresectable hepatocellular carcinoma." Lancet.
3. US FDA. (2018). "Approval of PLUVICTO for RCC." FDA.gov
4. EMA. (2019). "PLUVICTO approval decision for HCC."
5. ClinicalTrials.gov. Database of ongoing clinical trials involving PLUVICTO.

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This comprehensive market and clinical landscape analysis aims to inform strategic decisions on investment, development, and commercialization pathways for PLUVICTO.