CLINICAL TRIALS PROFILE FOR TECENTRIQ

All Clinical Trials for TECENTRIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Hoffmann-La Roche	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Genentech, Inc.	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT01656642 ↗	A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma	Completed	Genentech, Inc.	Phase 1	2012-08-13	This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled participants may continue treatment until they are no longer experiencing clinical benefit as assessed by the investigator and in alignment with the protocol.
NCT01810913 ↗	Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer	Recruiting	National Cancer Institute (NCI)	Phase 2/Phase 3	2013-03-18	This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
NCT01810913 ↗	Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer	Recruiting	NRG Oncology	Phase 2/Phase 3	2013-03-18	This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Clinical Trial Conditions for TECENTRIQ

Condition Name

Condition Name for TECENTRIQ
Intervention	Trials
Non-Small Cell Lung Cancer	16
Hepatocellular Carcinoma	14
Breast Cancer	12
Solid Tumor	11

Condition MeSH

Condition MeSH for TECENTRIQ
Intervention	Trials
Carcinoma	88
Lung Neoplasms	51
Carcinoma, Non-Small-Cell Lung	50
Neoplasms	31

Clinical Trial Locations for TECENTRIQ

Trials by Country

Trials by Country for TECENTRIQ
Location	Trials
Spain	231
Italy	230
Canada	92
Brazil	90
Australia	77

Trials by US State

Trials by US State for TECENTRIQ
Location	Trials
California	88
Texas	85
New York	78
Tennessee	68
Florida	63

Clinical Trial Progress for TECENTRIQ

Clinical Trial Phase

Clinical Trial Phase for TECENTRIQ
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	5
Phase 3	42

Clinical Trial Status

Clinical Trial Status for TECENTRIQ
Clinical Trial Phase	Trials
Recruiting	144
Not yet recruiting	55
Active, not recruiting	54

Clinical Trial Sponsors for TECENTRIQ

Sponsor Name

Sponsor Name for TECENTRIQ
Sponsor	Trials
Hoffmann-La Roche	87
National Cancer Institute (NCI)	67
Genentech, Inc.	65

Sponsor Type

Sponsor Type for TECENTRIQ
Sponsor	Trials
Other	284
Industry	251
NIH	67

Last updated: May 10, 2026

TECENTRIQ (atezolizumab) Clinical Trials Update, Market Analysis, and Projection

What is TECENTRIQ’s current clinical development and labeling footprint?

TECENTRIQ (atezolizumab) is the anti–PD-L1 program of Genentech/Roche used across multiple oncology indications, primarily in combination regimens and select monotherapy settings. The commercial and clinical strategy concentrates on expanding (1) line-of-therapy positions, (2) biomarker-defined cohorts (PD-L1 and tumor-infiltrating immune markers), and (3) combinations with cytotoxics, anti-VEGF, and other immunotherapies across solid tumors.

Core approved platform indications (selected, non-exhaustive):

• Urothelial carcinoma: advanced disease settings and peri-cycling positions in combination with chemotherapy or post-platinum strategies (US/EU approvals vary by sub-indication and time).
• Non-small cell lung cancer (NSCLC): PD-L1-defined and combination regimens (including historically with bevacizumab and chemotherapy in specific profiles).
• Small cell lung cancer (SCLC): combination chemotherapy and immunotherapy approaches.
• Triple-negative breast cancer (TNBC): PD-L1 positive populations.
• Hepatocellular carcinoma (HCC): combination with bevacizumab.
• Renal cell carcinoma (RCC): combination strategies in specified risk and line settings (including PD-L1 and broader use via combination regimens).

Where the program is most active clinically (pattern-based update):

• Combinations remain dominant. Atezolizumab’s clinical trial density is highest in studies that pair PD-L1 blockade with systemic backbone regimens (platinum doublets, taxanes, anti-VEGF, or other checkpoint agents).
• Biomarker stratification continues to refine patient selection. Across tumor types, the recent clinical update pattern focuses on narrowing to PD-L1/immune phenotype-defined groups and exploring whether outcomes persist in “broader” biomarker populations.
• Earlier-line trials and maintenance-like strategies continue to be the main expansion vector, aiming to improve durability and depth of response while controlling toxicity.

Trial status conventions used in market projections below:

• “Ongoing” means sponsor active studies (new enrollment or running analysis) typically listed on ClinicalTrials.gov / registries.
• “Completed but not yet registrational” means results exist in the public record but do not yet translate to a labeled expansion.
• “Registrational” means pivotal studies intended to support label change.

What does the current clinical evidence imply for TECENTRIQ’s near-term lifecycle?

The atezolizumab franchise has entered a phase where growth is constrained more by competitive and line-of-therapy dynamics than by basic proof-of-concept. Commercially, the next meaningful step-ups typically require:

• Demonstrating incremental survival benefit over current standards in a defined subgroup (often PD-L1-defined or immune-marked).
• Securing label expansions that move TECENTRIQ earlier or reduce the need for strict biomarker thresholds.
• Protecting existing indications from therapeutic displacement by faster-moving PD-1 assets and combination standards.

Where are the major competitive pressure points for TECENTRIQ?

In the modern immune-oncology landscape, PD-1 inhibitors and PD-L1 inhibitors face head-to-head displacement through:

• Combination sequencing (first-line and subsequent lines).
• Biomarker strategy drift (from strict PD-L1 cutoff to broader treatment strategies).
• Safety-driven regimen selection, especially when immunotherapy is paired with chemotherapy or anti-VEGF.

For business planning, the key question is not whether atezolizumab is active clinically. It is whether its ongoing evidence produces label-relevant advantages against the dominant competing regimens in each tumor type, particularly where payers and formularies push toward fewer regimen permutations.

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What is TECENTRIQ’s market reality and revenue trajectory?

How big is TECENTRIQ’s market today and what has driven it?

Atezolizumab revenue is the product of:

• Indication breadth (urothelial, NSCLC, SCLC, TNBC, HCC, RCC and related sub-settings).
• Penetration in combination regimens (where regimen standardization affects share).
• Line-of-therapy movement and durability of response.

Market drivers that historically supported growth:

• Urothelial carcinoma adoption in post-platinum or combination strategies.
• NSCLC use in PD-L1 stratified populations and combination backbones.
• Strong uptake in HCC settings when used with bevacizumab.

Market constraints that affect forward projections:

• Competitive displacement by PD-1 inhibitors with broader label utility.
• Changes in clinical practice and biomarker frameworks.
• Increased regimen consolidation as trials mature and guidelines stabilize.

What share factors matter most to forecast TECENTRIQ performance?

For a PD-L1/IO franchise, share is typically determined by these levers:

1. Guideline positioning (first-line vs subsequent-line).
2. Label breadth and biomarker cutoff flexibility.
3. Payer and formulary preference (reimbursement and contract dynamics).
4. Safety and tolerability profile in combination (leading to practical treatment adoption).
5. Oncology regimen standardization in each tumor type.

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What is the projection for TECENTRIQ through the next cycle window?

Atezolizumab’s forward trajectory depends on whether new label expansions arrive and on the speed of displacement in competitive lung and urothelial standards. Under a lifecycle framework, the forecast can be expressed as a scenario tree:

Projection framework (scenario-based, decision-grade)

Base case (most likely):

• Modest revenue growth or stabilization driven by continued uptake in labeled combinations, offset by competitive displacement in NSCLC and urothelial where PD-1-driven standards dominate.
• Clinical adds land primarily in narrow subgroups or sequencing refinements rather than broad label resets.

Bull case (upside):

• One or two registrational label expansions succeed in earlier-line settings or in broader biomarker populations.
• Evidence supports meaningful outcomes in a high-volume setting and sustains regimen inclusion in guidelines.

Bear case (downside):

• Displacement accelerates faster than label additions because competing regimens capture first-line and chemo-immunotherapy slots earlier.
• Remaining pipeline does not translate into registrational value or comes too late to defend share.

Commercial outcome sensitivity

The largest revenue inflection points typically come from:

• First-line NSCLC positioning.
• Urothelial carcinoma sequence locks.
• Any new registrational win in a high-incidence tumor type with simplified biomarker requirements.
• Consolidation effects: fewer regimen options can structurally reduce PD-1/PD-L1 class shares.

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What clinical-trial signals should investors track for TECENTRIQ?

Registrational endpoints and proof quality:

• Overall survival (OS) and progression-free survival (PFS) in the target subgroup
• Response durability metrics (DoR)
• Safety profile stability in combination regimens
• Biomarker strategy performance (PD-L1 and immune phenotypes)

Decision timing:

• Trials that finalize enrollment and read out within 12 to 24 months are the most relevant to near-term label outcomes.
• Later-stage studies that only produce exploratory subgroup signals usually do not alter payer behavior quickly enough to move revenue materially.

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Key Takeaways

• TECENTRIQ’s near-term strategy is label defense plus targeted expansions, primarily through combination regimens and biomarker-defined cohorts across major solid tumor indications.
• Market performance is most sensitive to competitive displacement in NSCLC and urothelial standards and to whether atezolizumab can secure registrational label changes that widen patient eligibility.
• Base-case trajectory is stabilization with limited upside, unless a high-volume registrational win shifts guideline positioning or biomarker requirements.
• Investment-grade monitoring points are OS/PFS strength in the intended population, durability, and whether results support guideline-level adoption.

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FAQs

1. Is TECENTRIQ primarily a monotherapy or combination drug in current clinical practice?
   It is predominantly used in combination regimens across most major indications, with monotherapy confined to selected settings and biomarker-defined cohorts.

2. Which biomarkers are most relevant to TECENTRIQ trial outcomes?
   PD-L1 status and immune-related biomarkers used in patient stratification and subgroup analyses drive both trial design and clinical adoption.

3. What endpoints most influence label expansion decisions for atezolizumab?
   Overall survival, progression-free survival, response durability, and safety in the specific intended subgroup.

4. What competitive products most pressure TECENTRIQ’s share?
   PD-1 inhibitor-based standards in chemo-immunotherapy and subsequent-line strategies across lung and urothelial cancers.

5. What would create the biggest revenue upside for TECENTRIQ?
   A registrational label expansion in a high-incidence setting that moves treatment earlier and/or broadens eligibility beyond strict biomarker cutoffs.

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References

[1] ClinicalTrials.gov. “Atezolizumab (TECENTRIQ) Trials.” https://clinicaltrials.gov/
[2] FDA. “TECENTRIQ (atezolizumab) Prescribing Information.” https://www.accessdata.fda.gov/
[3] EMA. “Tecentriq: Summary of Product Characteristics (SmPC).” https://www.ema.europa.eu/
[4] Roche/Genentech. “TECENTRIQ (atezolizumab) Clinical Studies and Publications.” https://www.roche.com/