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Last Updated: January 4, 2025

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CLINICAL TRIALS PROFILE FOR TAGRISSO


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All Clinical Trials for TAGRISSO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02465060 ↗ Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting National Cancer Institute (NCI) Phase 2 2015-08-12 This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
NCT02496663 ↗ Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor Active, not recruiting National Cancer Institute (NCI) Phase 1 2016-03-24 This phase I trial studies the side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a better treatment for EGFR-mutant non-small cell lung cancer.
NCT02503722 ↗ Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer Active, not recruiting National Cancer Institute (NCI) Phase 1 2016-10-13 This phase I trial studies the side effects and best dose of sapanisertib when given together with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02520778 ↗ Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Active, not recruiting National Cancer Institute (NCI) Phase 1 2016-03-31 This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body (metastatic) or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02736513 ↗ Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases Active, not recruiting Rabin Medical Center Phase 2 2016-05-01 Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.
NCT02736513 ↗ Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases Active, not recruiting Soroka University Medical Center Phase 2 2016-05-01 Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.
NCT02759835 ↗ Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib Active, not recruiting National Cancer Institute (NCI) Phase 2 2016-04-13 Background: Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein called EGFR. This particular cancer can be treated with certain drugs such as Erlotinib (Tarceva), Gefitinib (Iressa) and Osimertinib (Tagrisso). But many tumors become resistant to these drugs because of a second mutation. Researchers want to test if adding local ablative therapy (LAT) extends the benefits of the drug, Osimertinib. LAT can include techniques such as surgery, radiofrequency ablation, cryotherapy or radiation therapy. Objective: To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people whose NSCLC has progressed after initial treatment with osimertinib. Eligibility: Adults ages 18 and older with certain types of NSCLC. Participants will be divided into various groups as described below. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Tumor scans Eye exam Review of tumor sample. Participants will take the study drug by mouth once a day. They will continue until they can no longer tolerate it or their disease worsens. They will keep a dosage diary. All participants will start each 21-day course with physical exam; blood, urine, and saliva tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3 months. Groups 1 and 2 will: Start osimertinib right away. Have LAT if their disease gets worse and is suitable for LAT. If LAT cannot be performed or LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Re-start osimertinib after LAT, or other treatments if not suitable for LAT. Group 3 will: Have LAT. If LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Start osimertinib after LAT. After participants stop taking the drugs, they will have a final visit. This will include: Medical history Physical exam Heart and blood tests Participants will be called every year for follow-up.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TAGRISSO

Condition Name

Condition Name for TAGRISSO
Intervention Trials
Stage IV Lung Cancer AJCC v8 11
Stage IVA Lung Cancer AJCC v8 10
Non-small Cell Lung Cancer 10
Stage IVB Lung Cancer AJCC v8 10
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Condition MeSH

Condition MeSH for TAGRISSO
Intervention Trials
Carcinoma, Non-Small-Cell Lung 54
Lung Neoplasms 42
Carcinoma 19
Neoplasms 7
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Clinical Trial Locations for TAGRISSO

Trials by Country

Trials by Country for TAGRISSO
Location Trials
United States 266
China 23
Italy 21
Korea, Republic of 20
France 15
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Trials by US State

Trials by US State for TAGRISSO
Location Trials
California 23
Texas 14
Massachusetts 13
Ohio 12
Florida 11
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Clinical Trial Progress for TAGRISSO

Clinical Trial Phase

Clinical Trial Phase for TAGRISSO
Clinical Trial Phase Trials
Phase 3 6
Phase 2 32
Phase 1/Phase 2 11
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Clinical Trial Status

Clinical Trial Status for TAGRISSO
Clinical Trial Phase Trials
Recruiting 30
Not yet recruiting 20
Active, not recruiting 15
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Clinical Trial Sponsors for TAGRISSO

Sponsor Name

Sponsor Name for TAGRISSO
Sponsor Trials
National Cancer Institute (NCI) 19
AstraZeneca 17
M.D. Anderson Cancer Center 4
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Sponsor Type

Sponsor Type for TAGRISSO
Sponsor Trials
Other 52
Industry 41
NIH 19
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TAGRISSO Market Analysis and Financial Projection

Tagrisso: A Leading Edge in Non-Small Cell Lung Cancer Treatment

Introduction to Tagrisso

Tagrisso, developed by AstraZeneca, is a small-molecule kinase inhibitor that has revolutionized the treatment of non-small cell lung cancer (NSCLC), particularly in patients with specific EGFR mutations. Here, we delve into the clinical trials, market analysis, and projections for this groundbreaking drug.

Clinical Trials and Efficacy

Early Approval and Trial Design

Tagrisso was first approved by the FDA in 2015 based on evidence from two global clinical trials involving 411 patients with advanced NSCLC who had progressed on prior systemic therapy, including EGFR tyrosine kinase inhibitor therapy. These trials were multicenter, single-arm, and open-label, with patients required to have EGFR T790M mutation-positive NSCLC detected by the cobas® EGFR mutation test. The primary efficacy outcome measure was the objective response rate (ORR) according to RECIST v1.1, evaluated by a Blinded Independent Central Review (BICR)[1].

Recent Trials and Outcomes

In recent years, Tagrisso has continued to demonstrate its efficacy in various clinical trials:

  • LAURA Trial: This Phase III trial showed that Tagrisso reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer compared to placebo. The median progression-free survival (PFS) was 39.1 months for Tagrisso-treated patients versus 5.6 months for those on placebo[4].

  • FLAURA2 Trial: Results from this trial indicated that Tagrisso provided an improved overall survival (OS) of 6.8 months compared to its competitors, with a hazard ratio of 0.80 (P=0.046). Additionally, 28% of patients receiving Tagrisso were still on treatment at three years, compared to 9% in the comparator arms[3].

  • ADAURA Trial: Tagrisso is the only targeted therapy to improve patient outcomes in early-stage disease, as demonstrated in the ADAURA Phase III trial. It has also shown benefits in locally advanced stages in the LAURA trial and late-stage disease in the FLAURA and FLAURA2 trials[4].

Market Analysis and Projections

Market Dominance

Tagrisso is projected to be a pivotal contributor to AstraZeneca’s portfolio, with anticipated sales surpassing $7 billion by 2029. This would give it a 48% market share of small molecules in lung cancer treatment, making it the leader in this niche market[2][5].

Sales Performance

In 2022, Tagrisso generated $5.44 billion in sales, a 15% increase from 2021. This performance underscores its significance within AstraZeneca’s oncology portfolio, outpacing other notable drugs like Imfinzi and Lynparza[2].

Market Landscape

The overall NSCLC market is dominated by immunotherapies, with Merck’s Keytruda leading the way. However, small molecules like Tagrisso are carving out a significant niche. The small molecule treatment market for NSCLC is expected to reach over $15 billion by 2029, with Tagrisso at the forefront[2][5].

Competitor Analysis

Roche is expected to secure the second position in the market with projected sales of over $2.5 billion and a 17% market share by 2029. Other players, such as Amgen, are also anticipated to have a presence, though significantly smaller compared to Tagrisso[2][5].

Future Directions and Pipeline

Ongoing and Upcoming Trials

AstraZeneca is committed to further expanding the use of Tagrisso. It is currently being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. Additionally, trials like the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, are exploring ways to address tumor mechanisms of resistance[4].

Potential Expansion

Tagrisso is also being appraised in a basket Phase II MATCH trial by the National Cancer Institute to observe if treating cancers via specific genetic biomarkers improves treatment outcomes. If successful, this could further expand its indications and solidify its position as a leading EGFRm TKI[3].

Key Takeaways

  • Clinical Efficacy: Tagrisso has demonstrated significant efficacy in various clinical trials, including the LAURA, FLAURA2, and ADAURA trials.
  • Market Leadership: Projected to lead the small molecule lung cancer treatment market with sales exceeding $7 billion by 2029.
  • Market Share: Expected to hold a 48% market share of small molecules in lung cancer treatment.
  • Future Directions: Ongoing and upcoming trials aim to expand its use in different settings and address tumor resistance mechanisms.

FAQs

What is Tagrisso used for?

Tagrisso is used to treat non-small cell lung cancer (NSCLC) in patients with specific EGFR mutations, including the T790M mutation.

When was Tagrisso first approved?

Tagrisso was first approved by the FDA in 2015.

What are the key clinical trials for Tagrisso?

Key trials include the AURA, LAURA, FLAURA, FLAURA2, and ADAURA trials, which have demonstrated its efficacy in various stages of NSCLC.

How much is Tagrisso projected to earn by 2029?

Tagrisso is projected to earn over $7 billion by 2029, according to GlobalData.

What is the market share of Tagrisso in the small molecule lung cancer treatment market?

Tagrisso is expected to hold a 48% market share of small molecules in lung cancer treatment by 2029.

What other drugs are in the pipeline for AstraZeneca in lung cancer treatment?

Other promising pipeline drugs include Orpathys and Lynparza, which are undergoing clinical trials for lung cancer treatment.

Sources

  1. FDA: Drug Trials Snapshot: TAGRISSO - FDA
  2. FiercePharma: AstraZeneca's Tagrisso to lead niche lung cancer market
  3. Clinical Trials Arena: AstraZeneca's Tagrisso maintains momentum in NSCLC with FLAURA2 results
  4. AstraZeneca: Tagrisso reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer vs. placebo
  5. European Pharmaceutical Review: Research predicts 2029 small molecule oncology market leaders

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