Delving into the Latest Updates on Osimertinib mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[11C]osimertinib, ADAURA, Mereletinib

+ [14]

Target

EGFR L858R x EGFR T790M x EGFR-Ex19del

Action

inhibitors

Mechanism

EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases+ [5]

Active Indication

Non-Small Cell Lung CancerEGFR positive non-small cell lung cancerEGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer+ [35]

Inactive Indication

Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPleural Effusion

Originator Organization

AstraZeneca Pharmaceuticals Co. Ltd.

Active Organization

AstraZeneca Investment (China) Co. Ltd.

AstraZeneca PLC

Eli Lilly & Co.

+ [8]

Inactive Organization

EpimAb Biotherapeutics, Inc.Roche Pharma AG

License Organization

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

Thermo Fisher Scientific, Inc.

EpimAb Biotherapeutics, Inc.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (13 Nov 2015),

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Priority Review (Australia), Accelerated assessment (European Union), Special Review Project (China), Priority Review (China)

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Structure/Sequence

Molecular FormulaC29H37N7O5S

InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N

CAS Registry1421373-66-1

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi), Osi alone, or standard of care (SOC) alone.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 optimized doses of telisotuzumab adizutecan from the dose escalation phase with Osi, or Osi alone. In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 694 adult participants with mCRC will be enrolled in the study in 200 sites worldwide.
In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. During dose optimization participants will receive OSi alone or with 1 of 3 optimized doses of telisotuzumab adizutecan. In stage 2 participnats will recieve the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Start Date08 Sep 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06630325

/ Not yet recruitingPhase 2IIT

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

Start Date16 Jun 2025

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+3]

NCT06918782

/ Not yet recruitingPhase 2

Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma

The aims of this study are to determine the potential clinical benefits (in terms of PFS, objective response and OS) of add-on systemic chemotherapy (pemetrexed+carboplatin/cisplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma, i.e. failure of plasma ctDNA EGFR mutant clearance at week 3 after osimertinib treatment

Start Date01 May 2025

Sponsor / Collaborator

The University of Hong Kong

100 Clinical Results associated with Osimertinib mesylate

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100 Translational Medicine associated with Osimertinib mesylate

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100 Patents (Medical) associated with Osimertinib mesylate

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4,579

Literatures (Medical) associated with Osimertinib mesylate

31 Dec 2025·ANNALS OF MEDICINE

Comparison of first-generation EGFR-TKIs combined with low-dose bevacizumab versus osimertinib in untreated advanced EGFR-mutated NSCLC

Article

Author: Xu, Yingqi ; Zhong, Runbo ; Jin, Hongping ; Zhong, Hua ; Lou, Yuqing ; Zhang, Yidan ; Xu, Jianlin

BACKGROUND:

This study aimed to compare the efficacy of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) combined with low-dose bevacizumab(7.5 mg/kg) versus osimertinib as first-line treatment in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS:

A total of 161 patients with advanced NSCLC harboring EGFR mutations, who received first-line treatment at Shanghai Chest Hospital between July 2017 and July 2023, were enrolled in this study. Among them, 78 patients were treated with a combination of first-generation EGFR-TKIs and bevacizumab (7.5 mg/kg), constituting the bevacizumab plus TKI (A + T) group. The remaining 83 patients received osimertinib monotherapy (80 mg daily), forming the osimertinib group.

RESULTS:

The objective response rate (ORR) was 65.4% (51/78) in the A + T group and 68.7% (57/83) in the osimertinib group (p = 0.657). Despite the potentially poorer baseline conditions of patients in the osimertinib group, the median progression-free survival (PFS) was 16.59 months (95% CI: 14.39-18.80) in the A + T group compared to 16.82 months (95% CI: 13.76-19.89) in the osimertinib group (p = 0.792). Preliminary overall survival (OS) analysis indicated a median OS of 51.75 months (95% CI: 41.63-61.86) in the A + T group versus 35.55 months (95% CI: 22.32-48.77) in the osimertinib group (p = 0.010), however, the OS data are not yet mature.

CONCLUSION:

Although osimertinib remains the preferred first-line treatment for advanced NSCLC with EGFR mutations, combining first-generation EGFR-TKIs with low-dose bevacizumab may be a viable alternative for certain patients.

01 Dec 2025·LUNG

Update 2025: Management of Non‑Small-Cell Lung Cancer

Review

Author: Jeon, Hyein ; Wang, Shuai ; Song, Junmin ; Gill, Harjot ; Cheng, Haiying

Abstract:

Lung cancer remains the leading cause of cancer-related mortality worldwide. Since 2024, the non–small-cell lung cancer (NSCLC) landscape has undergone a transformative shift, driven by 11 FDA approvals. Recent advances in molecular profiling, targeted therapies, and immunotherapies have revolutionized NSCLC management, ushering in an era of personalized treatment with improved patient outcomes. The increased adoption of low-dose computed tomography (LDCT) for screening has enhanced early detection, enabling intervention at more curable stages. Molecular diagnostics now play a pivotal role in guiding treatment strategies, with actionable genomic alterations (AGAs) informing the use of EGFR, ALK, ROS1, KRAS, NRG1, and other targeted inhibitors in both early and advanced settings. For instance, targeted therapies are increasingly being integrated into early-stage management, with adjuvant osimertinib for EGFR-mutated NSCLC and alectinib for ALK-positive NSCLC demonstrating substantial survival benefits. Immunotherapy, particularly immune checkpoint inhibitors, has become a cornerstone of treatment for AGA-negative NSCLC, either as monotherapy or in combination with chemotherapy, and is increasingly being utilized in the perioperative setting. Furthermore, emerging therapies such as bispecific antibodies, antibody–drug conjugates (ADCs), and novel immunotherapeutic agents show promise in addressing resistance mechanisms and improving outcomes in advanced-stage disease. Although new challenges arise, the evolving NSCLC treatment paradigm continues to prioritize precision medicine, offering hope for prolonged survival and enhanced quality of life for patients.

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

801

News (Medical) associated with Osimertinib mesylate

17 Jun 2025

·www.prnewswire.com

Lung Cancer Research Foundation Announces Request for Proposals Focused on Curing EGFR Mutant Lung Cancers

New Team Science Award is $1.5 million Over Three Years NEW YORK, June 17, 2025 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) announces today a new funding mechanism: the 2025 LCRF Team Science Award on Advancing Therapies Toward Curing EGFR Mutated Lung Cancers. The Request for Proposals is now open for submissions. Designed to bring together scientific teams to accomplish innovative breakthroughs, this team science award must include at least two projects directed at understanding and treatment of resistant or persistent disease in EGFR mutated lung cancer. Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 124,730 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers. Epidermal growth factor receptor (EGFR) mutations were the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibitors (TKIs). Subsequently additional oncogenic driver alterations in EML4-ALK, BRAF, RET, KRAS G12C, HER2, MET, NTRK, ROS1 and NRG1 were identified along with corresponding therapeutic options for treatment. Several TKIs including gefitinib, erlotinib, afatinib, dacomitinib, and osimertinib have been approved by the FDA for the treatment of EGFR mutated (EGFRmut+) Non Small Cell Lung Cancer (NSCLC.) Despite substantial progress in the treatment of EGFRmut+ lung cancer, available treatments are not curative, and resistance invariably develops. Sometimes biopsies are repeated to identify the source of resistance to potentially evaluate patients for additional targeted therapy. Usually, at some point in time chemotherapy is employed to treat the disease. Immunotherapy in the form of PD-1/PD-L1 inhibitors has revolutionized the treatment of many forms of lung cancer but has not proven effective in the treatment of most oncogene-driven lung cancers. Given that therapeutic options available to date are not curative, there is a need for novel approaches to treat these lung cancers and improve outcomes for patients with the ultimate intention of cure. This grant mechanism will focus on furthering the development of novel therapies for patients with EGFRmut+ NSCLC. "There has been so much scientific discovery in EGFR mutated lung cancer, and with the development of targeted treatments, patients are living longer," said Benay Taub, lung cancer survivor. "However, even with the best of circumstances, resistance develops and we need patients to have more treatment options. The goal of this award is to support a team of committed researchers in pursuit of improved treatments and outcomes for lung cancer patients and hopefully, one day, a cure." "EGFR discoveries were the start of oncogene-driven treatment and while the science has made great strides, there is still a significant need for more to be discovered," says Dr. Antoinette Wozniak, Chief Scientific Officer for LCRF. "Our commitment to people affected by lung cancer is simple: continue to fund research that pushes the boundaries of what is known to what is possible – toward a cure. This award will hopefully move the science in that direction." "Tomorrow's breakthroughs are made possible by research that happens today," emphasized David Carbone, MD, PhD, Director, Translational Therapeutics Program, The Ohio State University Wexner Medical Center and member of LCRF's Scientific Advisory Board. "Taking a team approach to combatting resistance in EGFR mutant lung cancer promises to accelerate the pace of discovery." This new Team Science Award is made possible by a generous private donation from Benay and Steven Taub. Their visionary support reflects a deep belief in the power of collaboration to drive scientific discovery. Submissions to the Request for Proposals will be reviewed through a two-step process: Letters of Intent will be accepted until midnight on July 29, 2025; if selected, projects will then be chosen to submit full proposals. All applications will be subject to a rigorous review by LCRF's Scientific Advisory Board. More details about the Request for Proposal, along with eligibility, requirements, and deadlines can be found at LCRF.org/FundingOpportunities. Siegel RL, Giaquinto AM, Jemal A. CA: A Cancer Journal for Clinicians, Vol 24,Issue 1, Jan/Feb 2024 About the Lung Cancer Research Foundation (LCRF) The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF's mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 429 research grants, totaling nearly $48 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information about the LCRF grant program and funding opportunities, visit lcrf.org/research. Contact: LUNG CANCER RESEARCH FOUNDATION (LCRF) Sheila Sullivan Sr. Director, Marketing & Communications [email protected] SOURCE Lung Cancer Research Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyClinical Study

03 Jun 2025

·www.fiercebiotech.com

ASCO: Guardant blood test guides breast cancer therapy switches, extending survival in AZ-backed study

An interim analysis of the results found that the patients who switched therapies based on the Guardant test results experienced median progression-free survival of 16 months, compared to 9.2 months for the participants who stayed on first-line endocrine therapy. \n A new study, sponsored by AstraZeneca and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this week, suggests that using the Guardant360 CDx test to spot early signs of therapy resistance in advanced breast cancer patients and inform a treatment change could slash the risk of disease progression or death by half.Guardant Health’s blood test already has one FDA-approved use in breast cancer, as it was greenlit in 2023 as a companion diagnostic for Menarini’s Orserdu. The test, which analyzes circulating tumor DNA (ctDNA), is used to identify patients with ER-positive, HER2-negative advanced or metastatic breast cancer who have ESR1 mutations—which are linked to resistance to standard endocrine therapies—and so may see better results with the oral selective estrogen receptor degrader (SERD).The Serena-6 study, the results of which were published this month in the New England Journal of Medicine alongside the ASCO presentation, used the test’s ESR1 mutation-spotting abilities to guide treatment changes in breast cancer patients at the earliest signs of resistance to first-line endocrine therapy, even before regular imaging was showing any disease progression.In the study, more than 3,200 patients with advanced ER-positive, HER2-negative breast cancer were tested with Guardant360 CDx every two or three months. If the test picked up on an emerging ESR1 mutation, and disease progression wasn’t yet showing up in imaging scans, patients were assigned to either continue their endocrine therapy—an aromatase inhibitor plus a CDK4/6 inhibitor—or to swap the aromatase inhibitor for AstraZeneca’s next-gen oral SERD, camizestrant.Ultimately, 315 patients were eligible for the experiment, with half assigned to each group. An interim analysis of the results found that the patients who switched to camizestrant based on the Guardant test results experienced median progression-free survival of 16 months, compared to 9.2 months for the participants who stayed on endocrine therapy. According to Guardant, that translates to a 56% reduced risk of disease progression or death for the camizestrant group.Additionally, in an exploratory endpoint for the study, those who switched to camizestrant went a median of 23 months until “a deterioration in the patient-reported global health status and quality of life,” compared to just 6.4 months for those in the endocrine therapy group. The study is still ongoing, as investigators gather more data to calculate overall survival and time to second disease progression, among other secondary endpoints, per AstraZeneca.Guardant billed the study as the first such phase 3 trial to rely on a ctDNA-guided approach to spot emerging endocrine resistance and inform a therapy switch before disease progression showed up in imaging, creating “a new paradigm” in cancer treatment, according to Helmy Eltoukhy, Guardant chairman and co-CEO.“This use of the Guardant360 CDx test highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice and improve outcomes in patients with advanced breast cancer,” Eltoukhy added in the company’s announcement Monday.Outside of breast cancer, the liquid biopsy is also approved as a companion diagnostic to spot several biomarkers in lung cancer patients, to better match them to AstraZeneca’s Tagrisso or Enhertu, Johnson & Johnson’s Rybrevant or Amgen’s Lumakras.

Clinical ResultPhase 3ASCO

02 Jun 2025

·www.globenewswire.com

Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test

PRESS RELEASE 02/06/2025, 10:00 CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla™ Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework. The IVDR-certified Idylla™ EGFR Mutation Test is designed to serve as a CDx for the detection of EGFR exon 19 deletions and the L858R mutation, which are key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). The IVDR certification confirms the Test’s compliance with Europe’s rigorous new regulatory standards, ensuring enhanced patient safety, improved information transparency, and robust data traceability. Designed for use on the Idylla™ Platform, the Test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene – all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, and the remaining mutations have been analytically validated. Utilizing formalin-fixed, paraffin-embedded (FFPE) tissue samples, the Test is fully automated from sample to result, delivering fast results in under 3 hours – streamlining laboratory workflows and empowering oncologists with timely treatment decisions for their patients. With 99.2% sensitivity (PPA) and 99.0% specificity (NPA) for the CDx targets, the Idylla™ EGFR Mutation Test ensures accurate detection of key EGFR mutations, providing healthcare professionals with actionable results to guide treatment decisions in NSCLC. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. While the IVDR-certified Idylla™ EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively – Biocartis is also developing the Idylla™ EGFR CDx Test in the US with AstraZeneca. Upon approval, the Test will be intended to help identify patients with NSCLC who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca’s third-generation EGFR-TKI treatment. Roger Moody, Chief Executive Officer of Biocartis, commented: “Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence. This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio. The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.” ----- END ----- More information: www.biocartis.com info@biocartis.com Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting lung, skin, thyroid, colorectal, endometrial, blood, brain and breast cancer. More information: www.biocartis.com. Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © June 2025, Biocartis NV. All rights reserved.

Diagnostic ReagentsClinical Study

100 Deals associated with Osimertinib mesylate

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External Link

KEGG	Wiki	ATC	Drug Bank
D10766	Osimertinib mesylate	L01XE	DB09330

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Canada	AstraZeneca Canada, Inc.	05 Jul 2016
EGFR positive non-small cell lung cancer	Japan	AstraZeneca Pharmaceuticals Co. Ltd.	28 Mar 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	European Union	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Iceland	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	United States	AstraZeneca Pharmaceuticals LP	13 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	United States	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	China	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	France	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Malaysia	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Poland	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Taiwan Province	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	United Kingdom	AstraZeneca PLC	08 May 2023
Carcinoma	Phase 3	United States	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	China	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Japan	AstraZeneca PLC	03 Aug 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Lung Cancer	Not Applicable	EGFR mutation Glioblastoma EGFR mutations	-	osimertinib (Biopsy specimens)	xidfybwvnc(ivmxxzmwwv) = jhmtiyffla gmsufcrory (muxwkctila ) View more	-	01 Jun 2025
				osimertinib (Resection specimens)	xidfybwvnc(ivmxxzmwwv) = ectgjdcklu gmsufcrory (muxwkctila ) View more
NCT03944772 (ORCHARD, Pubmed \| JCO Precis Oncol)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR amplification \| G724 mutation \| exon 20 insertion	19	Osimertinib + Necitumumab	gnpcffcamm(imzkjcdddv) = kffaiszfdy sbyphpjkny (zqgqapdqyg, 3 - 26) View more	Negative	01 Jun 2025
NCT04351555 (NeoADAURA, ASCO2025) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer Neoadjuvant EGFR L858R \| EGFR Exon 19 Deletion	358	Osimertinib + Chemotherapy	ldndgddhvl(srvjywevyv) = focolwaedu daujxogkhb (yhjtzflqcu, 18 - 34) View more	Positive	30 May 2025
				OsimertinibOsimertinib Monotherapy	ldndgddhvl(srvjywevyv) = uawiuaakua daujxogkhb (yhjtzflqcu, 17 - 34) View more
NCT03778229 (SAVANNAH, ASCO2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line FISH10+ \| MET IHC3+/≥90%	73	Savolitinib 300 mg BID + Osimertinib 80 mg QD	rgeolrcjws(hiqlcawhuf) = lfqvpikbxn vnupspyxje (ugzcrlxqwk, 43 - 72) View more	Positive	30 May 2025
				SavolitinibSavolitinib 300 mg BID + Placebo	rgeolrcjws(hiqlcawhuf) = kevxhrtpvt vnupspyxje (ugzcrlxqwk, 5 - 36) View more
ASCO2025	Not Applicable	Non-Small Cell Lung Cancer EGFR mutation	161	Osimertinib	hyxwndorjr(bywzkctpti) = lzbyknxfcs pijzzuhvdf (ldiqhrtens ) View more	Positive	30 May 2025
				Local Therapy (LT)	wyezqwrgsv(indpiabmad) = tzlqtjhqeb gwjechezvj (jfbnpbccqw ) View more
NCT04772235 (TOTEM, ASCO2025)	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR mutations	15	Osimertinib 80mg QD + Repotrectinib 80mg QD	nfcgsefine(bsukvamplr) = Most side effects were grade 1-2, including anemia tymrrxevyk (vwuueakdow ) View more	Positive	30 May 2025
1LEGFR-mutated metastatic non-small cell lung cancer (ASCO2025)	Not Applicable	metastatic non-small cell lung cancer EGFR	171	Osimertinib full dose	svstacfpou(chtqyhvakg) = All dose-reduced pts experienced AEs, compared to 48% of full-dose pts nbrrljicbk (yybxnonxxi ) View more	Negative	30 May 2025
				Osimertinib dose reduction
ASCO2025	Phase 3	EGFR-mutated non-small Cell Lung Cancer Neoadjuvant exon 21 L858R mutations \| exon 18 G719X mutations	51	Osimertinib alone	zfjbvbwudf(bojgpyvplh) = eyfvotnaoo ucksmmsbnc (wvjfvyamti ) View more	Negative	30 May 2025
				Platinum-based doublet chemotherapy alone	nklavcgfxv(zbqnbzxdyw) = gvblvmvveo pofmpfbbtx (nfdvlibyeg )
ASCO2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line EGFR	18	Osimertinib	emxbcynpha(kxwhkzrtre) = csrmqrzalz qenbklsfyi (zvsdgaiplv ) View more	Positive	30 May 2025
ADAURA (ASCO2025)	Phase 3	EGFR positive non-small cell lung cancer Adjuvant EGFR mutation-positive	732	Adjuvant Osimertinib	fbnhwnldfq(wapeotxvbh) = In our study, there were 13 (45%) grade 1, 13 (45%) grade 2, 1 (3%) grade 4, and 2 (7%) AE of unknown grade. In ADAURA, there were 493 (69%) grade 1, 202 (28%) grade 2, and 22 (3%) grade 3 AE. hjgstpiluy (gpoefwkozz ) View more	Positive	30 May 2025