Delving into the Latest Updates on Osimertinib mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[11C]osimertinib, ADAURA, Mereletinib

+ [16]

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+ [1]

Active Indication

Non-Small Cell Lung CancerEGFR positive non-small cell lung cancerEGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer+ [29]

Inactive Indication

Adenocarcinoma of LungAdvanced Malignant Solid NeoplasmMetastatic Malignant Neoplasm to the Leptomeninges+ [3]

Originator Organization

AstraZeneca Pharmaceuticals Co. Ltd.

Active Organization

AstraZeneca Investment (China) Co. Ltd.

AstraZeneca PLCAstraZeneca AB

+ [9]

Inactive Organization

Roche Pharma AG

License Organization

Suzhou Genhouse Bio Co., Ltd.

Thermo Fisher Scientific, Inc.

EpimAb Biotherapeutics, Inc.

+ [6]

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), Priority Review (China), Breakthrough Therapy (China), Priority Review (Australia), Accelerated assessment (European Union), Special Review Project (China)

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Structure/Sequence

Molecular FormulaC29H37N7O5S

InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N

CAS Registry1421373-66-1

A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Start Date30 Sep 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07710612

/ Not yet recruitingPhase 2

A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer

Start Date31 Aug 2026

Sponsor / Collaborator

Abbisko Therapeutics Co., Ltd.

[+1]

NCT07738172

/ RecruitingPhase 3IIT

A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy

Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.
This multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.
All participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.

Start Date01 Aug 2026

Sponsor / Collaborator

National Taiwan University Hospital

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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4,524

Literatures (Medical) associated with Osimertinib mesylate

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer

Article

Author: Hearmon, Natalie ; Upton, Elysia ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Karia, Pritesh ; Lopes, Gilberto de Lima

OBJECTIVES:

Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.

METHODS:

A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.

RESULTS:

The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.

LIMITATIONS:

Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.

CONCLUSIONS:

From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.

31 Dec 2026·RENAL FAILURE

A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk

Article

Author: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Han, Jinfen ; Lyu, Jiayi ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi

Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.

01 Sep 2026·NEOPLASIA

DRIVE: a comprehensive resource deciphering drug-induced transcriptomic and splicing response in cancer cell

Article

Author: Wang, Wei-Liang ; Tang, Hong-Feng ; Wu, Tao

Pharmacotherapy induces complex molecular reprogramming in cancer, driving transcriptome-wide alterations and widespread dysregulation of alternative splicing. Despite these profound changes, there remain limited resources characterizing drug-induced whole-transcriptomic responses in cancer. Furthermore, while aberrant splicing can generate immunogenic neoantigens, existing resources fail to systematically integrate drug perturbations, splicing dynamics, and neoantigen landscapes. To address this gap, the DRIVE database was constructed as a comprehensive resource detailing drug-induced transcriptomic and splicing responses. Utilizing the large language models for rigorous metadata curation and construct the standardized processing pipeline, thousands of publicly available raw transcriptomic datasets from drug-treated and control cancer cell lines were systematically processed. The resulting repository encompasses 3,911 samples, involving 278 drugs and 272 cell lines, enabling the precise quantification of differential gene expression, differential alternative splicing events, and the prediction of splicing-derived human leukocyte antigen-binding peptides. Analysis of the data revealed that drug-induced transcriptomic reprogramming is highly context-dependent and correlated with chemical structural similarity. We identified Osimertinib as a potential immunomodulatory agent associated with transcriptional signatures of an activated tumor microenvironment, while KB-0742 emerged as an unappreciated candidate global splicing modulator. Furthermore, our large-scale prediction of differential splicing-derived neoantigens uncovered several drugs that warrant further investigation as candidates for combination immunotherapy. DRIVE also provides a user-friendly interface to browse datasets, perform drug enrichment and connectivity analysis. (https://componclab.com/DRIVE). This database could improve our understanding of molecular reprogramming under pharmacotherapy, and serve as a valuable platform for deciphering drug mechanisms, promoting virtual cell modeling and discovering novel strategies of drug repurposing.

984

News (Medical) associated with Osimertinib mesylate

18 Aug 2026

·www.fiercepharma.com

Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test

Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout. The Panku-Lung01 lung cancer trial met its primary endpoint at an interim analysis, showing a significant progression-free survival benefit for iza-bren, Biokin said Tuesday in a securities filing (Chinese, PDF). The study in China tested the EGFRxHER3 bispecific ADC against platinum-based chemotherapy in patients with advanced EGFR-mutated nonsquamous non-small cell lung cancer following treatment with an EGFR tyrosine kinase inhibitor (TKI). A positive trend toward an overall survival improvement was also observed, according to Biokin. The phase 3 win from China boosts the chance of success for BMS’ global counterpart trial, Izabright-Lung01, a phase 2/3 trial launched in November 2025 and expected to read out in 2028. In both studies, patients are required to have progressed on a third-generation EGFR TKI. Previously, in a subgroup of chemo-naïve patients who had failed on a third-generation EGFR TKI, a phase 2 trial linked iza-bren to a median PFS of 12.5 months, according to data presented at the World Conference on Lung Cancer 2025. The New Jersey pharma is preparing to launch an ambitious phase 3 trial, Izabright-Lung02, in first-line EGFR-mutated NSCLC. The study, the fourth global phase 3 that BMS has outlined for iza-bren, will test the bispecific ADC in combination with AstraZeneca’s Tagrisso against either Tagrisso alone or its combination with chemo. Another set of phase 2 results shared at WCLC 2025 showed a 100% objective response rate for a combination of iza-bren and Tagrisso in first-line EGFR-mutated NSCLC. After a median follow-up of 12.8 months, the median duration of response and PFS had not been reached at that time. For reference, in the phase 3 Flaura2 trial, Tagrisso plus chemo registered an ORR of 77% in the same treatment setting. Iza-bren has been on a winning streak since BMS paid $800 million upfront to license the drug as part of a potential $8.4 billion deal signed in late 2023. For Biokin, Panku-Lung01 marks the fourth positive phase 3 trial the Chinese drugmaker has reported for iza-bren. The drug got its first regulatory approval in June when China’s National Medical Products Administration cleared it for recurrent or metastatic nasopharyngeal carcinoma following previous treatment with PD-1/L1 and chemo based on data from the Panku-NPC01 trial. The drug quickly added previously treated esophageal squamous cell carcinoma to its China label in July, thanks to positive PFS and OS results from the Panku-Esophagus01 study. In what could be iza-bren’s third indication, Chinese regulators are reviewing the drug for previously treated triple-negative breast cancer (TNBC). In the Panku-Breast02 trial, iza-bren significantly reduced the risk of death by 40% versus physician’s choice of chemotherapy, according to data presented at the American Society of Clinical Oncology annual meeting in June. BMS, taking a step further, has moved iza-bren into global phase 3 testing in first-line TNBC, as the Izabright-Breast01 trial in PD-(L)1-ineligible patients is projected to read out in 2028. Together, BMS and Biokin have launched 20 phase 3 or phase 2/3 trials for iza-bren globally or in China, according to Biokin. In both EGFR-mutated NSCLC and TNBC, iza-bren poses a threat to TROP2-targeted ADCs, including AstraZeneca and Daiichi Sankyo’s Datroway , Gilead Sciences’ Trodelvy and Merck & Co. and Kelun-Biotech’s sac-TMT . RELATED: ASCO: Bristol Myers’ $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice Getting ever more ambitious and potentially adding more pressure on TROP2 ADCs, Biokin is also initiating a phase 3 trial in first-line NSCLC. The China study, dubbed Panku-Lung05 , will evaluate iza-bren in combination with a PD-1xVEGF bispecific antibody—one of the hottest frontiers in oncology drug development—for squamous NSCLC. All the iza-bren advancement comes as Biokin is gunning for a double listing on the Hong Kong Stock Exchange after pulling the plug days before a planned IPO last November.

Phase 3Clinical ResultASCODrug ApprovalPhase 2

18 Aug 2026

·www.biopharmadive.com

AstraZeneca scores in lung cancer; Sandoz inks a China deal

Today, a brief rundown of news involving AstraZeneca and a legal battle between Celgene shareholders and Bristol Myers Squibb, as well as updates from MapLight Therapeutics and Sandoz that you may have missed.A combination of AstraZenecas drug Tagrisso and Hutchmeds Orpathys helped people with a type of mutated lung cancer live longer than those given chemotherapy, the companies said Monday. The trial was in people with EGFR-positive non-small cell lung cancer that is driven by a mutation called MET whod already had their disease get worse after first- or second-line treatment with Tagrisso. The combination delayed disease progression or death compared with chemotherapy, as well as extending overall survival, the companies said. In a statement, Susan Galbraith, AstraZenecas executive vice president of oncology and hematology research, said the companies aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. Tagrisso is approved in the U.S. and other major jurisdictions, while Orpathys, which AstraZeneca is commercializing, is approved in China and Switzerland. Jonathan GardnerChinese pharmaceutical firm Shanghai Henlius Biotech announced Monday it inked a deal with Sandoz to license out three biosimilars in a pact worth as much as $232 million. Per the agreement, Sandoz is expected to pay just over $100 million in 2026 for near-copies of Eli Lillys Erbitux, or cetuximab; Amgens Repatha, or evolocumab; and GSKs Benlysta, or belimumab. Sandoz also acquired the option to license HLXTE-HAase1001, an experimental compound that Henlius said can convert time-consuming intravenous infusion into rapid subcutaneous injection. The Swiss generic drugmaker was the first to win approvalfor a biosimilar two decades ago as part of Novartis, and now makes roughly 1,300 medicines. Gwendolyn WuA federal appeals court resurrected a lawsuit by investors of Celgene against Bristol Myers Squibb over contingent payments promised under the two companies 2019 acquisition deal. The former Celgene investors, through their trustee, UMB Bank, have claimed Bristol Myers intentionally slowed development of the Celgene-developed cancer cell therapy Breyanzi to avoid paying out more than $6 billion due as part of a contingent value right that helped get the deal to completion. A federal district judge in 2024 ruled that UMB had been improperly appointed trustee, negating its claims. Appeals court Judge Beth Robinson last week ruled that because all parties to the agreement recognized UMB as the trustee, it had standing to sue. The case will now be sent back to the district court for further argument. Jonathan GardnerMapLight Therapeutics is considering partnerships as a path forward for one of its most advanced research projects. Tucked into the companys earnings report late last week was an update on ML-004, a drug designed to bind to serotonin receptors. ML-004 recently came up short in a mid-stage study focused on autism spectrum disorder, but MapLight still touts how it appeared safe and demonstrated clinically meaningful improvements in irritability. The company is now deciding what to do with the drug, with possible options including strategic collaborations, funding alternatives or both. Analysts havent attributed much of MapLights value to ML-004. At TD Cowen, for example, analyst Joseph Thome doesnt factor it into his model, viewing the program instead as an upside optionality. Jacob Bell '

AcquisitionDrug ApprovalCell Therapy

17 Aug 2026

·www.fiercepharma.com

AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure

AstraZeneca reported positive results from two non-small cell lung cancer trials for Enhertu and an Orpathys-Tagrisso combination, although the dual wins provided little cover for the company amid the failure of a PD-1/CTLA-4 bispecific antibody. In a pair of phase 3 wins, AZ and Daiichi Sankyo’s Enhertu improved progression-free survival against Merck & Co.’s Keytruda and chemotherapy in first-line HER2-mutant nonsquamous NSCLC, and AZ and Hutchmed’s Orpathys and Tagrisso outperformed platinum-based chemotherapy on both PFS and overall survival in Tagrisso-pretreated EGFR-mutated NSCLC. In both cases, AZ said the data will be presented at a medical meeting and shared with global regulatory authorities. However, the two successes were overshadowed by the phase 3 crash of volrustomig, which failed to outdo Keytruda and chemo in first-line NSCLC patients whose tumors express PD-L1 at below 50%. The Enhertu and Orpathys-Tagrisso wins represent relatively niche populations. Between the two positive readouts, the phase 3 Saffron trial could net Orpathys, also known as savolitinib, its first U.S. approval. The c-MET inhibitor has been marketed in China since 2021, initially as a treatment for NSCLC with MET exon 14 skipping alterations. Last year, Chinese authorities approved the Orpathys-Tagrisso regimen for NSCLC patients with MET amplification following progression on a first-line EGFR inhibitor. The phase 3 Sachi trial conducted solely in China linked the combo to a 66% reduction in patients’ risk of progression or death versus platinum-based chemo. While both trials enrolled patients with MET amplification, Sachi allowed progression on various EGFR tyrosine kinase inhibitors (TKIs), whereas Saffron is only for post-Tagrisso patients. In a post-third-generation EGFR TKI subgroup in Sachi, the combo showed a PFS improvement of 68% compared with chemo. Following a preliminary analysis midway into the phase 2 Savannah study that supported the advancement of Orpathys-Tagrisso into phase 3 tests, AZ and Hutchmed increased the level of MET expression cut-off to IHC3+ intensity in at least 90% of tumor cells and/or FISH 10+. About 10% to 15% of NSCLC patients in Western populations and 30% to 40% of their peers in Asia have EGFR-mutated NSCLC. Among them, about a third of tumors are expected to develop high levels of MET overexpression or amplification after treatment with a third-generation EGFR TKI like Tagrisso, according to AZ’s estimates. “By combining Orpathys and Tagrisso, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe,” Susan Galbraith, Ph.D., AZ’s executive vice president of oncology hematology R&D, said in an Aug. 17 statement. As for Enhertu, with the Destiny-Lung04 trial, AZ and Daiichi are aiming the HER2-targeted antibody-drug conjugate toward patients with HER2-mutated tumors who make up about 2% to 4% of the NSCLC population. Prior to Monday’s announcement, Enhertu has been approved by the FDA since 2022 for previously treated HER2-mutant NSCLC. Now, as the first phase 3 trial to improve PFS versus standard of care in this first-line setting, Destiny-Lung04 could support Enhertu's move earlier in the treatment of HER2-mutant NSCLC, Galbraith said in a separate statement. “This aggressive lung cancer often affects younger patients and has historically had limited first-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes.” Volrustomig, Enhertu and Orpathys are part of AZ’s ambition to have medicines for more than half of all lung cancer patients by 2030. With volrustomig’s flop , the stakes are even higher for the British pharma’s next-generation lung cancer candidates, including its PD-1/TIGIT bispecific rilvegostomig and Daiichi-partnered TROP2 ADC Datroway, whose readout from the phase 3 Avanzar trial in first-line NSCLC is expected this year.

Phase 3Clinical ResultDrug ApprovalADC

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	China	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Japan	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	South Korea	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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03521154 (LAURA, Pubmed \| Lung Cancer)	Phase 3	Non-small cell lung cancer stage III EGFR-mutated	216	Osimertinib	obqbdkyowq(bsojrblulc) = gmxeezvmzr kjssdvtcfl (royjmbomgd ) View more	Positive	01 Aug 2026
				Placebo	obqbdkyowq(bsojrblulc) = cyyeqetvpy kjssdvtcfl (royjmbomgd ) View more
NCT03521154 (LAURA, Pubmed \| Eur J Cancer)	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	153	Osimertinib	typihelunv(euyjtiamfq): HR = 1.0 (95.0% CI, 0.63 - 1.58) View more	Positive	01 Jun 2026
				Placebo
NCT03944772 (ORCHARD, Pubmed \| Ann Oncol)	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR-mutated	69	Osimertinib + Datopotamab deruxtecan 4 mg/kg	lormwfkuqw(wwwnazqsxd) = zrpdiguauj ithzhypoew (hbbmeowdhp, 32 - 55) View more	Positive	01 Jun 2026
				Osimertinib + Datopotamab deruxtecan 6 mg/kg	lormwfkuqw(wwwnazqsxd) = zirqfwqidw ithzhypoew (hbbmeowdhp, 25 - 49) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	94	osimertinib (Early On-Target Toxicity Phenotype)	nkfizgitkk(fpylfyedvl) = The Early On-Target Toxicity Phenotype (≈33%) was characterized by early dermatologic and gastrointestinal toxicities (rash, diarrhea, mucositis) and the highest rate of dose modification (≈25-30%). The Cumulative Burden Phenotype (≈30%) was dominated by persistent constitutional and neurocognitive symptoms (fatigue, anorexia, dizziness, cognitive complaints) emerging with prolonged exposure, and showed an unfavorable survival trend. The Clinically Silent Exposure Phenotype (≈37%) was characterized by minimal persistent symptoms and low rates of dose modification (<10%) and were associated with longer survival. skeyibuqdp (bdfjrafgvn )	Positive	29 May 2026
				osimertinib (Cumulative Burden Phenotype)
NCT05513664 (ASCO2026)	Phase 2	EGFR exon 20 insertion	158	Becotarug plus osimertinib	bnviuyaelr(zrqtkvfacr) = qsnrmmoijs fsrnohatsq (cybivzhqwl, 36.24 - 57.73) View more	Positive	29 May 2026
				Osimertinib	bnviuyaelr(zrqtkvfacr) = tdzjssyqjk fsrnohatsq (cybivzhqwl, 3.53 - 15.60) View more
NCT05507606 (ASCO2026)	Phase 1	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line EGFR sensitive mutations (19 del/21 L858R) \| TP53 mutation	34	Osimertinib combined with bevacizumab and chemotherapy	cuvlqgfmwv(gfsbpnhfap) = swdgudwlhg snalavjzod (pqiwuiyevg, 80.32 - 99.28) View more	Positive	29 May 2026
				Osimertinib combined with bevacizumab and chemotherapy (19 del)	cuvlqgfmwv(gfsbpnhfap) = zlgzolhniz snalavjzod (pqiwuiyevg ) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	1,650	Osimertinib	nuknhkidvw(mtdgnwdvft) = rmcfmpvkup rwncfcfgiw (jqtwuguhlb )	Positive	29 May 2026
				IO-based therapy	nuknhkidvw(mtdgnwdvft) = izwpywfvke rwncfcfgiw (jqtwuguhlb )
HOT-Next001 (ASCO2026)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line uncommon EGFR mutations	162	Afatinib	owgvtzbflh(infdlypnek) = jpxdzhkftn vtnpikujnt (wcflsmfsdj ) View more	Negative	29 May 2026
				Osimertinib	owgvtzbflh(infdlypnek) = powjvmwbla vtnpikujnt (wcflsmfsdj ) View more
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer First line EGFR-mutant	470	Osimertinib (Stereotactic radiosurgery)	haetglzwjz(dwddgdutyu) = vlskpmydds qcdapnlfjg (zdjnqcfdot ) View more	Positive	29 May 2026
				Osimertinib	haetglzwjz(dwddgdutyu) = yeglkfxuoq qcdapnlfjg (zdjnqcfdot ) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	194	Osimertinib rechallenge	ggsqucexmi(rhfeisbxyz) = aanfsyqgvk cfmukyspsc (xfkdgvjuih ) View more	Positive	29 May 2026
				switching to another EGFR-TKI	ggsqucexmi(rhfeisbxyz) = sdggtljbxs cfmukyspsc (xfkdgvjuih ) View more