Request Demo

Last update 25 Aug 2026

Osimertinib mesylate

Last update 25 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

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 PLC

Eli Lilly & Co.AstraZeneca 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)

Structure/Sequence

Molecular FormulaC29H37N7O5S

InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N

CAS Registry1421373-66-1

384

Clinical Trials associated with Osimertinib mesylate

NCT07680790

/ Not yet recruitingPhase 3

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]

NCT07153055

/ RecruitingPhase 1/2IIT

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).

Start Date01 Aug 2026

Sponsor / Collaborator

Indiana University

[+1]

100 Clinical Results associated with Osimertinib mesylate

100 Translational Medicine associated with Osimertinib mesylate

100 Patents (Medical) associated with Osimertinib mesylate

4,523

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.

986

News (Medical) associated with Osimertinib mesylate

21 Aug 2026

·www.prnewswire.com

AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline

Clinical data from AbbVie's ABBV-1480 (RC148) PD-1/VEGF bispecific antibody in the frontline non-small cell lung cancer (NSCLC) setting will be presented via an oral presentation Additionally, new data and updates from AbbVie's telisotuzumab adizutecan (Temab-A) and ABBV-706 programs across NSCLC and small cell lung cancer (SCLC) to be shared Research reflects AbbVie's strategy aimed at building a lung cancer pipeline spanning next-generation immunotherapies, targeted antibody-drug conjugates (ADCs) and the potential for novel combination approaches NORTH CHICAGO, Ill., Aug. 21, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data highlighting research programs across its lung cancer portfolio being presented at the 2026 World Conference on Lung Cancer (WCLC), including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The presentations span clinical, translational and real-world data across next-generation immunotherapies and targeted antibody-drug conjugates (ADCs), designed to generate insights into treatment burden, patient experience and biomarker identification that may help inform future research. "Our strategy in lung cancer is focused on building a complementary pipeline that brings together next-generation immunotherapies and targeted antibody-drug conjugates with the potential to address different aspects of tumor biology," said Daejin Abidoye, M.D., vice president and therapeutic area head of oncology, solid tumor and hematology at AbbVie. "Exploring the PD-1/VEGF approach represented by ABBV-1480 and the c-Met targeting by Temab-A are important elements of that strategy and may provide a foundation for potential novel combinations as we work to develop more tailored treatment approaches for people living with lung cancer." Advancing Novel Therapies Across Various Modalities in NSCLC Multiple presentations across AbbVie's NSCLC portfolio will showcase new studies and data analyses spanning multiple treatment modalities, highlighting first-line treatment approaches, patient experience and biomarker-informed research. ABBV-1480 (RC148): AbbVie, in partnership with RemeGen, will present Phase 1b data evaluating the investigational PD-1/VEGF bispecific antibody, ABBV-1480, in combination with platinum-based chemotherapy as a potential first-line treatment for advanced NSCLC. At the 10 mg/kg dose, identified as the recommended Phase 3 dose for further development in combination regimens in both squamous and non-squamous NSCLC, the primary endpoint of objective response rate (ORR) was 90.0% in squamous NSCLC (n=27/30) and 75.9% (n=22/29) in non-squamous NSCLC. The most common treatment-related adverse events (TRAEs) were a decrease in white blood cells, neutrophil, platelet counts and anemia. No grade ≥3 hemorrhages with the 10 mg combinations were observed. This overall manageable safety profile supports ongoing Phase 3 development for this novel investigational asset.1 Telisotuzumab adizutecan (Temab-A), an investigational c-Met-directed ADC with a topoisomerase 1 inhibitor (Top1i) payload: Building on encouraging preliminary activity2 observed in heavily pretreated patients, AbbVie initiated a Phase 1b/2 M24-536 study (NCT06772623). The study is evaluating a platinum-free combination of Temab-A and a PD-1 inhibitor, as a potential first-line treatment for advanced non-squamous NSCLC. The study includes analyses of c-Met and PD-L1 expression to identify the patients most likely to benefit from treatment.3 Temab-A is also being studied in epidermal growth factor receptor (EGFR)-mutated NSCLC as monotherapy or in combination with osimertinib (NCT07155187). Clinical Data Showcasing the Potential of ABBV-706 in SCLC ABBV-706 is an investigational SEZ6-targeted ADC with a Top1i payload, being evaluated in SCLC. Presentations at WCLC include research that further characterizes the program and the potential role of SEZ6 in SCLC. As previously reported, ABBV-706 demonstrated an ORR of 82% in patients with relapsed/refractory SCLC post platinum-based chemotherapy (n=17).4 New safety analyses from 240 patients who received ABBV-706 monotherapy showed generally manageable hematologic and gastrointestinal toxicities, with the most common gastrointestinal events, including nausea (35.8%), vomiting (17.5%) and diarrhea (10.8%), being largely low grade and most requiring no dose adjustments.5 Grade ≥3 treatment-related pneumonitis or interstitial lung disease was reported in 1.7% of patients receiving ABBV-706 monotherapy.6 Hematologic toxicities, including anemia, neutropenia and thrombocytopenia, were among the most common TRAEs.5 Serious TRAEs occurred in 12.5% of patients. ABBV-706 is being evaluated as monotherapy in a Phase 3 study (NCT07365241) and in combination with atezolizumab in the Phase 2 study (NCT07155174), in SCLC. Real-world research demonstrated that SEZ6 is broadly expressed in 91% of SCLC patients overall and in more than 96% of patients with brain or liver metastases. These findings further support SEZ6 as a potential therapeutic target in SCLC and other SEZ6-expressing tumors. 7 Additional details on key presentations are available below, and the full WCLC 2026 abstracts are available online. For information about AbbVie's clinical trial efforts in lung cancer, please visit clinicaltrials.gov. Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. AbbVie holds exclusive rights from RemeGen to develop, manufacture, and commercialize ABBV-1480 outside of the Greater China territory. Emrelis™ (telisotuzumab vedotin-tllv) is an approved medicine being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv). About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. About AbbVie in Oncology  AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.  Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit .  Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Zhang L, Zhao Y, Fan Y, et al. RC148 (ABBV-1480, PD-1/VEGF bispecific antibody) plus chemotherapy in first-line locally advanced or metastatic non-small cell lung cancer. Abstract OA14.01.03. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. De Miguel M, Yamamoto N, Raimbourg J, et al. ABBV-400, a c-Met protein-targeting antibody-drug conjugate (ADC), in patients with advanced EGFR wild-type non-squamous non-small cell lung cancer: results from a phase I study. Ann Oncol. 2024;35(Suppl):S805-S806. Abstract 1257MO. Horinouchi H, Cuppens K, Camidge DR, et al. Telisotuzumab adizutecan and PD-1 inhibitor in untreated advanced non-squamous non-small cell lung cancer: a phase 1b/2 study. Abstract P2.374. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Byers LA, Cho BC, Cooper AJ, et al. ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). J Clin Oncol 44, 8008-8008 (2026). Chiang AC, Byers LA, Cooper AJ, et al. Hematologic and Gastrointestinal Toxicity of ABBV-706 in Advanced Solid Tumors: Safety Profile from the First-in-Human Study. Abstract P3.316. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Paz-Ares L, Chandana S, Chiang AC, et al. Pneumonitis/Interstitial Lung Disease in the First-in-Human ABBV-706 Study: Incidence, Management, and Risk Factors. E-Poster EP13.32. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Jahchan N, Calip GS, Guadamuz JS, et al. SEZ6 is expressed across major clinical and demographic groups of SCLC patients: evidence from a US clinicogenomic database. Abstract P3.340. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultPhase 1ADCImmunotherapyPhase 3

20 Aug 2026

·www.fiercepharma.com

Fierce Pharma Asia—China's IIT scrutiny; Daiichi Sankyo, AZ ph. 3 win; Leo, Tanabe's dermatology deal

China's investigator-initiated trials, once praised for their speediness, have been drawn into scrutiny for a lack of transparency. AstraZeneca and Daiichi Sankyo's Enhertu earned a win in a phase 3 non-small cell lung cancer trial. Tanabe Pharma secured a $435 million payout for global rights to its dermatology rare disease treatment, dersimelagon. And more. 1. After 2 undisclosed gene therapy deaths, can China’s alternative regulatory path still be trusted? The high-speed regulatory pathway credited with fueling China’s biotech boom is under international scrutiny after several previously undisclosed deaths—beginning with two in young children with rare genetic conditions—were uncovered in a matter of weeks. China’s investigator-initiated trials (IIT) allow Chinese hospitals and academics to launch early-stage human trials under a separate regulatory pathway with less oversight than the traditional drug approval process. Fierce talked to experts about what the patient deaths and poor public disclosure could mean for the IIT system. 2. AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure In a pair of phase 3 readouts for niche populations in non-small cell lung cancer, AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu bested Keytruda in first-line HER2-mutant nonsquamous NSCLC, while its Huchmed-partnered Orpathys-Tagrisso combination outperformed platinum-based chemo in Tagrisso-pretreated EGFR-mutated disease. The wins, however, were overshadowed by a phase 3 flop from the investigational bispecific volrustomig, which failed to outdo Keytruda and chemo this week in first-line NSCLC patients whose tumors express PD-L1 at below 50%. 3. Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test Biokin Pharma’s phase 3 trial for iza-bren, a first in-class antibody drug conjugate that targets both EGFR and HER3, met its primary endpoint in an interim analysis, demonstrating significant progression-free survival benefits. The success of the trial conducted in China increases the chances of success for the drug’s global trial, which launches this fall and is spearheaded by global partner Bristol Myers Squibb. 4. Leo ‘really strengthening’ pipeline with $435M deal for Tanabe rare skin disease drug awaiting FDA nod Tanabe Pharma is set to receive $435 million in upfront and near-term milestone payments after a deal with Leo Pharma. In exchange, Leo gets global rights to dersimelagon, a treatment in development for the rare genetic dermatology conditions erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Tanabe announced a phase 3 win for the drug in both indications earlier this year and now awaits an approval decision from the FDA. 5. Sandoz strikes $322M biosimilars deal with Shanghai Henlius Amid growing biosimilar opportunities, Sandoz has entered a collaboration with Shanghai Henlius and procured rights to three early development biosimilars. Per the deal, which could cover as many as 10 biosimilars, Sandoz is paying $100.5 million for the initial assets upfront, and up to $322 million if development milestones are achieved. Third death in China's popular but opaque trials revealed, this time in CAR-T (Endpoints) SK strikes settlement with MSN over future Xcopri generic: reports Kolon TissueGene shrinks workforce after pivotal osteoarthritis trial miss Contractor SK Pharmteco heralds completion of 2 API plants in Ireland Aurobindo unit, China API maker dinged in latest round of FDA warning letters China's top drugmaker Hengrui sees profit growth squeezed by bulk-buying programs (Reuters) Sino Biopharmaceutical rebrands to SBP Group (release)

Phase 3License out/in

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

100 Deals associated with Osimertinib mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D10766	Osimertinib mesylate	L01XE	DB09330

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

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	butoeooaxy(xdqxhwqhbe) = knlxwphchz ppkgnxmufe (arlllnylig ) View more	Positive	01 Aug 2026
				Placebo	butoeooaxy(xdqxhwqhbe) = anqtoyvtna ppkgnxmufe (arlllnylig ) View more
NCT04001777 (Pubmed \| J Immunother Cancer)	Phase 1	EGFR-mutated non-small Cell Lung Cancer	64	Pelcitoclax+osimertinib (previously progressed after third-generation TKI treatment+chemotherapy)	ofyahneicy(vskzzumhos) = One dose-limiting toxicity occurred at pelcitoclax 240 mg rbxiwkzfhi (ucjnwcuwxj ) View more	Positive	01 Jul 2026
				Pelcitoclax+osimertinib (TKI treatment-naive±prior chemotherapy)
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	xblejkwxcb(zppioghzof) = xxqedsxcwx sdjtsbocfi (rmkhvaukeu, 32 - 55) View more	Positive	01 Jun 2026
				Osimertinib + Datopotamab deruxtecan 6 mg/kg	xblejkwxcb(zppioghzof) = zbwvcxdljr sdjtsbocfi (rmkhvaukeu, 25 - 49) View more
NCT03521154 (LAURA, Pubmed \| Eur J Cancer)	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	153	Osimertinib	fmjupstyjy(rxghezwygd): HR = 1.0 (95.0% CI, 0.63 - 1.58) View more	Positive	01 Jun 2026
				Placebo
ASCO2026	Not Applicable	metastatic non-small cell lung cancer EGFR mutation	2,062	osimertinib (stage IV EGFR-mutated NSCLC + with PE)	gerjofgiob(jkgmlefiyy) = jkugvkbikj hchtuhixaq (zcrwukeybp ) View more	Negative	29 May 2026
				osimertinib (stage IV EGFR-mutated NSCLC + without PE)	gerjofgiob(jkgmlefiyy) = wkkonlmchj hchtuhixaq (zcrwukeybp ) View more
NCT04769388 (FLAME, ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Ex19del \| EGFR L858R	80	Osimertinib plus carboplatin-pemetrexed	xdjgqmibyv(qgqosvluhj) = hcmegphmwi hkxbdqisww (rocfifkvwz ) View more	Positive	29 May 2026
				Osimertinib monotherapy	xdjgqmibyv(qgqosvluhj) = maposbsxqw hkxbdqisww (rocfifkvwz ) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	3,212	osimertinib (Current or former smokers)	oupcpgrhpw(flhsascbun) = tdedioyqdg jdbfpxoaqo (gixgyrdnkm ) View more	Positive	29 May 2026
				osimertinib (Never smokers)	oupcpgrhpw(flhsascbun) = dedeqbcdww jdbfpxoaqo (gixgyrdnkm ) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	1,650	Osimertinib	yxvvwizzpu(gtsggfyopr) = xjuissgssp kuwbcpdurt (ffmtrworpf )	Positive	29 May 2026
				IO-based therapy	yxvvwizzpu(gtsggfyopr) = mnkubzyyos kuwbcpdurt (ffmtrworpf )
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer First line EGFR-mutant	470	Osimertinib (Stereotactic radiosurgery)	xiikdjazes(ybarmjrsdd) = gmhsxwewxr caqwtioapj (ikipymqrbn ) View more	Positive	29 May 2026
				Osimertinib	xiikdjazes(ybarmjrsdd) = awshsajscy caqwtioapj (ikipymqrbn ) View more
ASCO2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	94	osimertinib (Early On-Target Toxicity Phenotype)	rsdivcriny(jfxqupejcg) = 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. xphgejcyur (zkzwzhwkzi )	Positive	29 May 2026
				osimertinib (Cumulative Burden Phenotype)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis