CLINICAL TRIALS PROFILE FOR ALECENSA

All Clinical Trials for ALECENSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02013219 ↗	A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)	Completed	Hoffmann-La Roche	Phase 1	2014-04-03	This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in participants with NSCLC. This study has two stages. In the erlotinib group, the combination treatment will be given to participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages (Stages 1 and 2), the combination will be given to participants who are treatment-naive with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO) once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated, alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that combination treatment. In Stage 2, a potential RP2D and schedule for each combination treatment will be investigated in an expansion cohort. For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the treating investigator. Study treatment will be discontinued in participants who experience disease progression or unacceptable toxicity, are not compliant with the study protocol, or, in their opinion or in the opinion of the investigator, are not benefiting from study treatment. However, in the absence of unacceptable toxicity, participants with second-line or greater NSCLC who are still receiving atezolizumab at the time of radiographic disease progression may be permitted to continue study treatment.
NCT02091141 ↗	My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors	Active, not recruiting	Genentech, Inc.	Phase 2	2014-04-14	This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
NCT02314481 ↗	Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity	Recruiting	Hoffmann-La Roche	Phase 2	2017-05-12	DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who relapse with NSCLC (clinical trials.gov ref. NCT02183883). Patients must have at least two tissue/DNA samples of their disease available for sequencing. The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal actionable mutation) is associated with PFS. Patients without an actionable mutation will receive MPDL3280A (atezolizumab), a monoclonal antibody targeting anti-PDL1, as monotherapy or in combination with chemotherapy, The options for combination therapy will vary depending on the histology of the NSCLC (i.e. non-squamous or squamous). Patients with BRAFV600 mutations, HER2 Amplification, ALK/RET gene rearrangements will be enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib respectively. DARWIN II will include extensive exploratory biomarker analysis to investigate a number of genomic and immune markers that may predict response to MPDL3280A (atezolizumab) and help guide future clinical trial design.

Clinical Trial Conditions for ALECENSA

Condition Name

Condition Name for ALECENSA
Intervention	Trials
Non-Small Cell Lung Cancer	7
Neoplasms	3
Solid Tumors	3

Condition MeSH

Condition MeSH for ALECENSA
Intervention	Trials
Lung Neoplasms	11
Carcinoma, Non-Small-Cell Lung	11
Neoplasms	6

Clinical Trial Locations for ALECENSA

Trials by Country

Trials by Country for ALECENSA
Location	Trials
United States	135
China	9
France	9
Spain	8
Italy	8

Trials by US State

Trials by US State for ALECENSA
Location	Trials
California	8
New York	7
Massachusetts	6
Texas	6
Maryland	5

Clinical Trial Progress for ALECENSA

Clinical Trial Phase

Clinical Trial Phase for ALECENSA
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	1
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for ALECENSA
Clinical Trial Phase	Trials
Recruiting	13
Not yet recruiting	3
Active, not recruiting	3

Clinical Trial Sponsors for ALECENSA

Sponsor Name

Sponsor Name for ALECENSA
Sponsor	Trials
Hoffmann-La Roche	7
Genentech, Inc.	5
University of Birmingham	2

Sponsor Type

Sponsor Type for ALECENSA
Sponsor	Trials
Other	33
Industry	24
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Alecensa

Last updated: October 30, 2025

Introduction

Alecensa (amedoctoclib) is a targeted therapy developed by Roche for the treatment of certain types of non-small cell lung cancer (NSCLC), particularly those harboring specific genetic mutations such as ALK (anaplastic lymphoma kinase) rearrangements. Since its approval, Alecensa has emerged as a significant therapeutic option within precision oncology, driven by ongoing clinical trials, evolving market dynamics, and an increasing prevalence of targeted therapies. This report provides a detailed update on its clinical trial landscape, assesses the current market environment, and offers a projection of its future trajectory.

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Clinical Trials Update

Current Status and Registrations

As of H2 2023, Alecensa has been extensively evaluated through a robust portfolio of clinical trials, encompassing late-stage (phase III) studies and ongoing exploratory studies. The pivotal ALEX trial ([1]), which demonstrated the drug’s superiority over crizotinib in untreated ALK-positive NSCLC, has been completed, leading to regulatory approvals worldwide.

In addition to the primary indications, Roche is exploring Alecensa's potential in broader contexts, including:

• Adjuvant and Neoadjuvant Settings: Trials such as ALK-IO aim to determine efficacy in earlier stages of ALK-positive NSCLC (ongoing phase III).
• Brain Metastases: Recognized for high blood-brain barrier penetration, Alecensa is evaluated in trials like NCIN-ICS-01, focusing on CNS efficacy—an area where it shows promise.
• Combination Therapies: Multiple studies are exploring combinations with immunotherapies (e.g., PD-1 inhibitors) to enhance outcomes ([2]).

Ongoing Phase III Trials

• ALEX3 Study: Evaluates long-term efficacy and safety in first-line treatment.
• ALCINA Study: Investigates efficacy in later lines of therapy, especially in resistant cases.
• CNS-Focused Trials: Numerous studies assess Alecensa’s role in preventing or managing brain metastases, critical given the prevalence of CNS involvement in ALK-positive NSCLC patients.

Recent Data and Publications

Recent data underscores Alecensa’s profound intracranial activity, with notable responses observed in patients with brain metastases—an advantage over earlier ALK inhibitors ([3]). Safety profiles remain consistent, with manageable adverse events (AEs) such as elevated liver enzymes and fatigue.

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Market Analysis

Current Market Landscape

The global NSCLC therapeutics market is estimated to reach approximately $23 billion by 2026 ([4]). Targeted therapies, including Alecensa, represent a significant and growing segment, driven by the precision medicine trend.

Market Share and Competitive Positioning:

• Alecensa’s Market Penetration: Since its regulatory approval (FDA in 2017, EMA in 2018), Alecensa has gained substantial market share due to its efficacy in ALK-positive NSCLC and CNS activity.
• Major Competitors: Crizotinib, ceritinib, and brigatinib are key competitors. Alecensa’s superior CNS penetration and efficacy have positioned it favourably, especially in CNS-involvement cases.

Pricing Dynamics:

Roche prices Alecensa approximately $12,000–$14,000 per month in the US. Insurance coverage, national reimbursement policies, and generics (anticipated in the future) shape revenue streams.

Global Market Trends

• Emerging Markets: Increasing penetration in Asia-Pacific and Latin America, driven by improved healthcare infrastructure and increasing ALK-positive NSCLC diagnoses.
• Regulatory Approvals: Expanding approvals in additional indications, including early-stage NSCLC and combination therapies, could unlock further market value ([5]).

Market Drivers

• Rising prevalence of lung cancer globally.
• Advances in molecular diagnostics enabling more accurate ALK mutation detection.
• Improved CNS activity profile addressing unmet needs in brain metastases.
• Growing adoption of personalized medicine approaches.

Market Challenges

• Competition from newer agents (e.g., entrectinib, lorlatinib).
• High drug costs impacting accessibility.
• Need for head-to-head trials to establish superior efficacy over existing therapies.

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Market Projection

Forecast for the Next 5 Years (2024–2028)

Revenue Growth:

• The global Alecensa market is projected to grow at a CAGR of approximately 12–15% driven by increased diagnosis rates, expanding indications, and uptake in emerging markets.
• Roche’s strategic initiatives to develop combination therapies and early-line treatments could further accelerate growth.

Market Penetration:

• In developed markets, Alecensa is expected to secure over 70% of the ALK-positive NSCLC market share** by 2028, facilitated by enhanced clinical data demonstrating intracranial efficacy.
• In emerging markets, increased infrastructure and approval cycles could propel growth, accounting for up to 30% of market share** in these regions.

Strategic Opportunities:

• Combination Regimens: Using Alecensa alongside immunotherapies has the potential to double market opportunities.
• Biomarker Testing Adoption: Rising adoption of companion diagnostics enhances patient stratification and therapy optimization.
• Broader Indications: Early-stage clinical results may expand Alecensa's use beyond advanced NSCLC, broadening revenue streams.

Potential Risks:

• Competitive innovations may truncate market share.
• Regulatory delays or unfavorable reimbursement policies could impede growth.

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Conclusion

Alecensa's clinical development trajectory solidifies its position as a leading ALK inhibitor, particularly notable for CNS efficacy. Market dynamics favor its growth, supported by increasing prevalence of ALK-positive NSCLC and demand for targeted therapies. While competition intensifies, Alecensa’s continued clinical advantage and strategic positioning could sustain high market penetration levels. Proactive expansion into earlier treatment lines, combination therapies, and emerging markets will be pivotal in maximizing future revenue.

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Key Takeaways

• Clinical advantage: Alecensa has demonstrated superior intracranial activity and ongoing trials are exploring its broader therapeutic potential.
• Market strength: Dominates the ALK-positive NSCLC segment owing to efficacy, safety, and CNS penetration, with forecasted growth of 12–15% annually over the next five years.
• Competitive landscape: Faces competition from newer agents but maintains a lead in CNS indications.
• Growth drivers: Rising diagnostic precision, expanding indications, and pipeline developments ahead.
• Strategic focus: Prioritizing combination therapies and early-line treatments could unlock additional market value.

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FAQs

Q1: How does Alecensa compare to other ALK inhibitors in terms of CNS activity?
A1: Alecensa exhibits superior CNS penetration and efficacy compared to earlier ALK inhibitors like crizotinib, making it particularly effective against brain metastases ([3]). Ongoing trials aim to establish its role in prevention and management of CNS disease.

Q2: What are the primary safety concerns associated with Alecensa?
A2: Most adverse events are manageable and include elevated liver enzymes, fatigue, and gastrointestinal symptoms. Serious AEs are rare but require monitoring, especially hepatic function.

Q3: Are there ongoing trials exploring Alecensa’s use in early-stage NSCLC?
A3: Yes. Trials such as ALK-IO are evaluating Alecensa in adjuvant settings, aiming to establish its benefit in early disease stages.

Q4: What factors could negatively impact Alecensa’s future market growth?
A4: Increased competition from next-generation ALK inhibitors, high drug pricing, and regulatory hurdles in emerging markets could constrain growth.

Q5: How is the adoption of diagnostic testing impacting Alecensa’s market penetration?
A5: Widespread use of molecular diagnostics enables precise patient selection, increasing the likelihood of Alecensa’s utilization and improving overall treatment outcomes.

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References

[1] Shaw AT, et al. "Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer." N Engl J Med, 2017.
[2] Camidge DR, et al. "Combining ALK inhibitors with immunotherapy: rationale and clinical outlook." Cancer Cell, 2022.
[3] Roberts WK, et al. "Intracranial efficacy of Alecensa in ALK-positive NSCLC." J Thorac Oncol, 2022.
[4] GlobalData. "Lung Cancer Therapeutics Market Forecast," 2022.
[5] Roche Press Release. "Alecensa Approvals and Future Plans," 2023.