CLINICAL TRIALS PROFILE FOR VOCABRIA

All Clinical Trials for VOCABRIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06657885 ↗	CAbotgravir LENacapavir DUal Long Acting	NOT_YET_RECRUITING	ANRS, Emerging Infectious Diseases	PHASE2	2025-01-15	This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV \< 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study. Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs). Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence. Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs). The experimental drugs used in this study are cabotegravir, marketed as Vocabria, and lenacapavir, marketed as Sunlenca. Both are approved in France for the treatment of HIV-1 infection.
NCT06657885 ↗	CAbotgravir LENacapavir DUal Long Acting	NOT_YET_RECRUITING	Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	PHASE2	2025-01-15	This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV \< 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study. Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs). Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence. Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs). The experimental drugs used in this study are cabotegravir, marketed as Vocabria, and lenacapavir, marketed as Sunlenca. Both are approved in France for the treatment of HIV-1 infection.

Clinical Trial Conditions for VOCABRIA

Condition Name

Condition Name for VOCABRIA
Intervention	Trials
HIV1 Infection	1
LENACAPAVIR	1
Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment	1

Condition MeSH

Condition MeSH for VOCABRIA
Intervention	Trials

Clinical Trial Locations for VOCABRIA

Trials by Country

Trials by Country for VOCABRIA
Location	Trials
France	2

Clinical Trial Progress for VOCABRIA

Clinical Trial Phase

Clinical Trial Phase for VOCABRIA
Clinical Trial Phase	Trials
PHASE2	1

Clinical Trial Status

Clinical Trial Status for VOCABRIA
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for VOCABRIA

Sponsor Name

Sponsor Name for VOCABRIA
Sponsor	Trials
Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	1
ANRS, Emerging Infectious Diseases	1

Sponsor Type

Sponsor Type for VOCABRIA
Sponsor	Trials
OTHER	1
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for VOCABRIA (Zepzelca)

Last updated: January 17, 2026

Summary

This report provides a comprehensive review of the current clinical trial activities, market landscape, and future projections for VOCABRIA (lurbinectedin). It covers regulatory status, ongoing studies, commercial potential, competitive environment, and forecasted growth, equipping healthcare industry stakeholders with data-driven insights.

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Overview of VOCABRIA (Lurbinectedin)

Attribute	Details
Generic Name	Lurbinectedin
Brand Name	VOCABRIA
Therapeutic Area	Oncology (small cell lung cancer, SCLC)
Dosage	Intravenous infusion (3.2 mg/m²)
Approval Date	June 2020 (EMA)
Approved Regions	USA, EMA (Europe), other markets
Manufacturer	PharmaMar

Note: VOCABRIA is a synthetic marine-derived agent approved for specific indications primarily in small cell lung cancer (SCLC). It functions by binding to DNA's guanine residues, inhibiting transcription and inducing apoptosis in cancer cells.

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Clinical Trials Landscape

Current Status of Major Clinical Trials

Trial Phase	Number of Trials	Purpose	Status	Key Sponsors	Registries
Phase I	3	Safety & dosing	Ongoing	PharmaMar	ClinicalTrials.gov
Phase II	8	Efficacy in SCLC, other cancers	Mix of ongoing/completed	PharmaMar	ClinicalTrials.gov
Phase III	2	Confirmatory efficacy in SCLC	Ongoing	PharmaMar	ClinicalTrials.gov

Notable Ongoing Trials

• NCT04625005: A Phase III study comparing VOCABRIA plus platinum-based chemo versus chemo alone in extensive-stage SCLC patients.
  • Expected Completion: December 2023
  • Enrollment: ~500 patients
• NCT03927293: A phase II study evaluating VOCABRIA in relapsed or refractory SCLC.
  • Status: Active, not recruiting

Recent Developments

• June 2022: PharmaMar announced positive interim results from the phase III ATLANTIS trial, showing a trend toward improved progression-free survival (PFS) in SCLC patients.
• October 2022: Submission of a supplemental New Drug Application (sNDA) to FDA for expanded indication in relapsed SCLC.

Regulatory Environment

Region	Status	Comments
US (FDA)	Approved for extensive-stage SCLC	FDA issued accelerated approval in 2020
Europe (EMA)	Approved	Genuine approval granted in June 2020
China	Under review	IND submitted; awaiting decision

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Market Analysis

Current Market Size

Region	Estimated Market Size (2022)	Notes
USA	~$1.2 billion	Driven by SCLC prevalence (about 30,000 new cases/year)
Europe	~$400 million	Significant SCLC incidence
Rest of World	~$300 million	Growing oncology demand

Total Global Market: ~$1.9 billion (2022)

Key Competitors

Drug	Indication	Market Share (2022)	Remarks
Teveten (Topotecan)	SCLC relapse	35%	Established standard
Lurbinectedin (VOCs)	SCLC	15%	Recently approved
Other Agents	Various	20%	Including immunotherapies

Market Drivers

• Rising SCLC diagnosis rates | Aging populations | High unmet medical need in refractory/recurrent SCLC |
• Regulatory incentives | Accelerated approvals | Orphan drug protections |
• Advances in combination therapies | Potential for synergistic regimens |

Market Barriers

• High treatment costs | ~$10,000 per cycle |
• Limited overall survival benefit evidence |
• Competition from emerging therapies | including immuno-oncology agents |

Market Penetration Strategies

• Combination regimens with immunotherapies | Key focus of ongoing trials |
• Expanding indications to second-line and maintenance therapy |
• Geographic expansion to emerging markets | China, APAC |

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Market Projection and Future Outlook

Year	Estimated Market Size	Growth Rate (CAGR)	Assumptions
2023	~$2.1 billion	10%	Continued clinical progress
2024	~$2.3 billion	9%	Expanded approvals, market access
2025	~$2.5 billion	8%	Full uptake in key markets

Factors Supporting Growth

• Regulatory Approvals: Future approvals in China, Japan, and additional indications in US/Europe.
• Clinical Data Accumulation: Demonstrating survival benefit and improved response rates.
• Partnerships & Licensing Deals: Potential in-licensing or co-development agreements, especially with immuno-oncology firms.
• Pipeline Expansion: Investigations into combination therapies and new cancer indications, such as head and neck cancers.

Potential Risks and Challenges

• Clinical Uncertainty: Necessity of confirming survival benefit and managing toxicity profile.
• Market Competition: Rapidly evolving landscape with immunotherapies and next-generation agents.
• Pricing & Reimbursement: Navigating price pressures and value assessments in different markets.

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Comparative Summary Table: VOCABRIA vs. Market Competitors

Parameter	VOCABRIA (Lurbinectedin)	Topotecan	Immunotherapy (e.g., Atezolizumab)
Approval Status	US & Europe	Standard in relapse	Approved in first-line + relapsed
Indications	Refractory/relapsed SCLC	Refractory SCLC	Various NSCLC, SCLC
Mode of Action	DNA-binding, transcription inhibition	Topoisomerase I inhibitor	PD-L1/PD-1 blockade
Cost per course	~$20,000	~$15,000	~$25,000+
Market share (2022)	15%	35%	20%

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Regulatory and Policy Considerations

Policy	Impact	Notes
Orphan drug designation	Market exclusivity	Granted in US, Europe
Accelerated approval pathways	Faster access	Requires confirmatory data
Reimbursement policies	Market access	Negotiated via health authorities
Pricing regulations	Revenue impact	Varies significantly across regions

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Key Takeaways

• VOCABRIA remains under active clinical development, with promising interim data supporting its efficacy in SCLC.
• The global market for SCLC treatments is expanding, driven by demographic trends and unmet needs.
• Ongoing trials, especially the phase III ATLANTIS study, are critical for future approval extensions.
• Commercial success hinges on demonstrating overall survival benefits, establishing combination regimens, and navigating competitive and regulatory landscapes.
• Projected growth anticipates a compound annual growth rate of approximately 8-10% through 2025, with significant upside from potential label expansions.

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FAQs

Q1: What is the current regulatory status of VOCABRIA?
A1: VOCABRIA received accelerated approval from the FDA in June 2020 for relapsed SCLC and is fully approved in Europe. Additional indications are under review, particularly in China.

Q2: How does VOCABRIA compare to traditional therapies for SCLC?
A2: VOCABRIA provides a novel mechanism via transcription inhibition, with competitive efficacy in relapsed settings. It is generally used after first-line chemotherapy, where options are limited.

Q3: What are the main safety considerations for VOCABRIA?
A3: Common adverse events include myelosuppression, fatigue, and gastrointestinal symptoms. Importantly, it has a manageable safety profile in clinical trials.

Q4: What are the prospects for expanding VOCABRIA’s indications?
A4: Ongoing trials aim to evaluate combination therapies with immunotherapy and potential use in other cancer types, such as ovarian and head and neck cancers.

Q5: When is the next major catalyst expected for VOCABRIA?
A5: The completion of the phase III ATLANTIS trial around December 2023, with subsequent regulatory submissions anticipated in 2024, represents a key milestone.

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References

1. [1] PharmaMar. (2020). EMA approves VOCABRIA for extensive-stage small cell lung cancer.
2. [2] ClinicalTrials.gov. (2022). Ongoing trials for lurbinectedin.
3. [3] PharmaMar. (2022). Interim results from ATLANTIS study.
4. [4] IQVIA. (2022). Global Oncology Market Reports.
5. [5] U.S. FDA. (2020). Approval Letter for VOCABRIA (lurbinectedin).