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.
NCT02314481 ↗	Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity	Recruiting	University College, London	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.
NCT02521051 ↗	Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer	Recruiting	Genentech, Inc.	Phase 1/Phase 2	2015-10-01	This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).
NCT02521051 ↗	Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer	Recruiting	Massachusetts General Hospital	Phase 1/Phase 2	2015-10-01	This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).

Clinical Trial Conditions for ALECENSA

Condition Name

Condition Name for ALECENSA
Intervention	Trials
Non-small Cell Lung Cancer	7
Neoplasms	3
Solid Tumors	3
Neoplasms by Site	2

Condition MeSH

Condition MeSH for ALECENSA
Intervention	Trials
Lung Neoplasms	11
Carcinoma, Non-Small-Cell Lung	11
Neoplasms	6
Thyroid Neoplasms	2

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
Takeda	2

Sponsor Type

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

ALECENSA (alectinib): Clinical-Phase Status, Market Dynamics, and 2025-2029 Projection

Last updated: May 3, 2026

What is ALECENSA’s current clinical positioning by line of therapy?

ALECENSA (alectinib, Roche/Genentech) is an ALK tyrosine kinase inhibitor (TKI) with a clinical footprint across metastatic ALK-positive non-small cell lung cancer (NSCLC) and multiple treatment settings. Current use is driven by label-aligned trial evidence and broad adoption in first-line metastatic disease (as an alternative to other ALK TKIs) and in subsequent lines based on prior ALK TKI exposure.

Core clinical evidence backbone (trial level)

The most market-relevant efficacy evidence cluster for ALECENSA includes overall survival (OS) and progression-free survival (PFS) endpoints in ALK-positive metastatic NSCLC cohorts:

Trial (Program)	Population	Key efficacy outcome used in practice	Business relevance
ALEX	Untreated metastatic ALK+ NSCLC	Improved PFS versus crizotinib; durable outcomes reported across follow-up	Anchors first-line adoption narrative for ALK+.
NP28673 (J-ALEX, and related)	Japanese untreated metastatic ALK+ NSCLC	PFS benefit and tolerability profile in country-specific context	Supports regional uptake and payer confidence.
Other ALK TKI sequencing/maintenance-adjacent studies	Previously treated ALK+ NSCLC	Activity in post–ALK TKI settings	Supports line-expansion and switching.

Sources: Roche ALEX program summaries and FDA label basis are reflected in the FDA prescribing information and Roche clinical publications [1], [2].

What are the key clinical trials updates likely to move the sales curve?

Sales impact from clinical updates typically comes from (i) label expansions (new patient subgroups, new lines, combination arms), (ii) post-marketing evidence that supports payer tightening or loosening, and (iii) competitive displacement trials.

Update channels to watch in 2025

The clinical update cadence for ALECENSA tends to be dominated by:

1. Longer-term follow-up reports from registration trials and pivotal comparative studies that affect OS confidence and sequencing patterns.
2. Studies that refine patient stratification (brain metastases status, baseline disease burden, prior TKI exposure) that can influence real-world selection.
3. Safety and tolerability updates that reduce discontinuation and dose interruptions.

FDA label scope indicates the on-label use cases are mature and that the commercial ceiling is more dependent on (a) competitive dynamics within ALK first-line and (b) penetration in post-progression cohorts than on new “core” efficacy breakthroughs [2]. For market projection, this means clinical updates are treated as incremental drivers unless they carry formal label expansion.

Sources: FDA Prescribing Information for ALECENSA and Roche program materials [2], [1].

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How large is the addressable ALK-positive metastatic NSCLC market for ALECENSA?

Epidemiology and segment logic

Market size for ALECENSA depends on:

• Incidence of NSCLC
• Proportion ALK-positive
• Proportion metastatic at diagnosis or developing metastatic disease
• Proportion treated with molecular-targeted therapy
• ALK TKI selection patterns in first-line and after progression

A market model for ALECENSA is therefore built from metastatic ALK+ NSCLC patient counts and applied to market penetration across lines.

Competitive treatment mix shaping uptake

The ALK TKI category is competitive and the commercial story is driven by first-line sequencing. In practice, the ALK TKI market allocates patients across a small set of agents based on:

• First-line evidence strength
• Intracranial activity
• Adverse event profiles (dose modifications, discontinuations)
• Payer and formulary preferences

ALECENSA’s durable outcomes and brain activity profile are central to its selection versus other ALK TKIs, as reflected in pivotal program framing [1], [2].

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What do recent market results imply for near-term demand?

Revenue durability and category share

ALECENSA has sustained growth because ALK-positive metastatic NSCLC is chronic under targeted therapy, and patients remain on therapy for extended periods when tolerability holds. Commercially, that translates into:

• Higher “patient-life” on therapy in early lines when outcomes are strong
• Lower churn when discontinuation due to toxicity is reduced

This is consistent with FDA-labeled dosing and safety management considerations for ALECENSA, which define real-world treatability constraints [2].

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How should ALECENSA 2025-2029 sales be projected?

Because you requested a market analysis and projection, the projection below is structured as a scenario model tied to observable commercial levers: (1) patient pool expansion (slow), (2) penetration and share within ALK-first-line and post-progression (competitive), and (3) price and reimbursement effects (policy-driven).

Projection framework

Base-case drivers

• Stable ALK-positive metastatic NSCLC incidence growth (modest).
• Maintain or slightly improve share due to established efficacy and intracranial activity evidence.
• Incremental share pressure from other ALK TKIs in select geographies or payer tiers.

Downside drivers

• Faster formulary switch to alternative agents in first-line (if newer data or access shifts).
• Higher toxicity-related discontinuation from real-world mix shifts.

Upside drivers

• Continued penetration in patients with brain metastases or earlier-line stratification.
• Label expansion or new subgroup evidence leads to payer reclassification.

5-year sales projection (index-based; category-anchored)

No single public source provides a complete global revenue time series down to 2025-2029 for ALECENSA in a way that supports a fully auditable dollar forecast here. Therefore, the projection is expressed as an indexed “global net sales trajectory” that can be scaled to your internal baseline.

Scenario	2025 index	2026 index	2027 index	2028 index	2029 index
Downside	100	102	103	103	101
Base case	100	106	110	112	114
Upside	100	109	115	121	126

Interpretation for business planning

• Base-case growth is driven by continued penetration and durable treatment duration in ALK+ metastatic NSCLC.
• The curve flattens after 2027 in the base case, reflecting category maturity and competitive saturation unless a label-expanding clinical update changes utilization patterns.
• Upside requires either competitive displacement away from rivals in payer networks or a subgroup/label effect that increases addressable utilization.

Sources: FDA label for ALECENSA informs dosing and on-label patient use distribution [2]; ALEX program evidence anchors efficacy-based adoption assumptions [1].

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What are the key commercial risks to the projection?

1) Competitive pressure in ALK first-line

Category competition is the principal risk to share. First-line is where market capture occurs and where churn risk is highest if payer preferences shift.

2) Payer access dynamics

Payers drive sequencing by formulary tiering. Once a payer designates a “preferred” ALK TKI, switching patterns can change quickly.

3) Safety and discontinuation in broader real-world populations

Even with strong trial efficacy, real-world adherence and discontinuation rates affect total patient-days on therapy, which drives revenue.

All three risks connect back to the dosing and safety framework in the FDA prescribing information [2].

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What should R&D and investment teams do now?

If you are planning R&D

• Prioritize studies that can change sequencing behavior (first-line shift, post-progression switching, or intracranial-first strategy).
• Design endpoints and subgroup plans around what payers and clinicians track: intracranial response consistency, treatment discontinuation drivers, and long-term OS confidence.

If you are making investment decisions

• Treat ALECENSA as a mature franchise where value is driven by (i) competitive share retention and (ii) durability of real-world persistence on treatment rather than by blockbuster new indication risks.
• Use the projection model to stress-test category share erosion in first-line and treat incremental clinical updates as “value only if label/payer-impactful.”

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Key Takeaways

• ALECENSA’s clinical position is anchored by the ALEX efficacy program and FDA-labeled use in metastatic ALK-positive NSCLC, supporting sustained utilization across lines [1], [2].
• For 2025-2029, the commercial trajectory is best modeled as stable category penetration with competitive-driven flattening after mid-decade unless label-expanding or payer-shifting evidence emerges.
• The main forecast risk is ALK first-line share loss due to formulary and competitive dynamics rather than lack of underlying efficacy.

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FAQs

1. What patient populations drive ALECENSA demand most?
   Metastatic ALK-positive NSCLC across first-line and subsequent lines on the FDA-labeled indications [2].

2. Which trial evidence is most important for adoption?
   The ALEX program underpins the first-line clinical rationale and durable benefit profile that supports ongoing uptake [1].

3. What is the biggest commercial risk for ALECENSA?
   Competitive pressure in ALK first-line that can shift payer preferences and reduce share [2].

4. How do clinical updates translate to sales?
   Clinical follow-up matters most when it changes perceived OS confidence, discontinuation risk, or leads to label or payer-relevant subgroup adoption.

5. What period shows the highest uncertainty in the projection?
   2026-2028, because category share changes typically happen when competitive access and sequencing rules evolve.

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References

[1] Roche/Genentech. ALEX (alectinib) clinical program materials and publications.
[2] U.S. Food and Drug Administration. ALECENSA (alectinib) prescribing information.