Delving into the Latest Updates on Afatinib Dimaleate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

afatinib, Afatinib dimaleate (USAN), Afatinib Maleate

+ [14]

Target

EGFR L858R x EGFR-Ex19del x HER4

Action

inhibitors, antagonists

Mechanism

EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors, HER4 antagonists(Receptor tyrosine-protein kinase erbB-4 antagonists)

Therapeutic Areas

NeoplasmsRespiratory DiseasesUrogenital Diseases+ [2]

Active Indication

metastatic non-small cell lung cancerNon-Small Cell Lung CancerEGFR positive non-small cell lung cancer+ [12]

Inactive Indication

Adenocarcinoma of LungAdvanced breast cancerAdvanced cancer+ [62]

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHBoehringer Ingelheim Pty Ltd.

+ [3]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (12 Jul 2013),

EGFR exon 19 Deletions Mutant Non-small Cell Lung CancerEGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)

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Structure/Sequence

Molecular FormulaC32H33ClFN5O11

InChIKeyUSNRYVNRPYXCSP-JUGPPOIOSA-N

CAS Registry850140-73-7

This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers.
The study will enroll healthy adult volunteers smoker to assess the systemic exposure and lung deposition of inhaled afatinib dimaleate. Participants will receive both the test inhaled formulation and the reference oral formulation in separate periods with delayed phase between treatments.
Key endpoints include maximum plasma concentration (Cmax), area under the concentration-time curve (AUC), and lung deposition assessed via bronchoalveolar lavage (BAL), frequency of occurrence of side effects and cases of toxicity during the studies

Start Date25 Aug 2025

Sponsor / Collaborator-

NCT06709859

/ RecruitingPhase 2IIT

A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

Start Date01 May 2025

Sponsor / Collaborator

Shanghai Public Health Clinical Center

NCT06753747

/ Not yet recruitingPhase 1/2IIT

A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The goal of this clinical trial is to learn if Afatinib plus Palbociclib works in previously treated recurrent or metastatic esophageal squamous cell carcinoma. It will also learn about the safety of the combination of Afatinib and Palbociclib. The main questions it aims to answer are:
What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)?
Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?

Start Date01 Apr 2025

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Afatinib Dimaleate

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100 Translational Medicine associated with Afatinib Dimaleate

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100 Patents (Medical) associated with Afatinib Dimaleate

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3,516

Literatures (Medical) associated with Afatinib Dimaleate

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Evolution of computational techniques against various KRAS mutants in search for therapeutic drugs: a review article

Review

Author: Subramaniyan, Vetriselvan ; Ogaly, Hanan A ; Mehmood, Ayesha ; Khalid, Asaad ; Wadood, Abdul ; Hakami, Mohammed Ageeli

KRAS was (Kirsten rat sarcoma viral oncogene homolog) revealed as an important target in current therapeutic cancer research because alteration of RAS (rat sarcoma viral oncogene homolog) protein has a critical role in malignant modification, tumor angiogenesis, and metastasis. For cancer treatment, designing competitive inhibitors for this attractive target was difficult. Nevertheless, computational investigations of the protein's dynamic behavior displayed the existence of temporary pockets that could be used to design allosteric inhibitors. The last decade witnessed intensive efforts to discover KRAS inhibitors. In 2021, the first KRAS G12C covalent inhibitor, AMG 510, received FDA (Food and drug administration) approval as an anticancer medication that paved the path for future treatment strategies against this target. Computer-aided drug designing discovery has long been used in drug development research targeting different KRAS mutants. In this review, the major breakthroughs in computational methods adapted to discover novel compounds for different mutations have been discussed. Undoubtedly, virtual screening and molecular dynamic (MD) simulation and molecular docking are the most considered approach, producing hits that can be employed in subsequent refinements. After comprehensive analysis, Afatinib and Quercetin were computationally identified as hits in different publications. Several authors conducted covalent docking studies with acryl amide warheads groups containing inhibitors. Future studies are needed to demonstrate their true potential. In-depth studies focusing on various allosteric pockets demonstrate that the switch I/II pocket is a suitable site for drug designing. In addition, machine learning and deep learning based approaches provide new insights for developing anti-KRAS drugs. We believe that this review provides extensive information to researchers globally and encourages further development in this particular area of research.

01 Dec 2025·PEDIATRIC BLOOD & CANCER

Successful Salvage Treatment With Afatinib and Anti‐PD‐1 Combined Chemotherapy in a Pediatric Patient With Relapsed Cellular‐Type Congenital Mesoblastic Nephroma Harboring an EGFR‐KDD Mutation

Letter

Author: Zhou, Chunlei ; Li, Tao ; Zhou, Jianfeng ; Zhang, Shaohua ; He, Lulu ; Li, Jian ; Zhou, Li ; Ma, Yan

01 Dec 2025·JOURNAL OF NEURO-ONCOLOGY

Impact of EGFR mutation subtypes and TKI generations on clinical outcomes in lung adenocarcinoma patients with brain metastases treated with gamma knife radiosurgery

Article

Author: Kim, Won ; Choi, Juwhan ; Kim, Jong Hyun ; Lee, Sung Yong ; Park, Chan ; Roh, Haewon

BACKGROUND:

Brain metastases are a common and severe complication in patients with lung adenocarcinoma (ADC) harboring epidermal growth factor receptor (EGFR) mutations. Gamma Knife Radiosurgery (GKRS) is a standard treatment for brain metastases, and its efficacy may be influenced by the type of EGFR mutation and the generation of tyrosine kinase inhibitors (TKIs) used. This retrospective study evaluated the impact of EGFR mutation subtypes (exon 19 deletion vs. exon 21 L858R) and TKI generations on clinical outcomes in patients with lung ADC treated with GKRS.

METHODS:

A total of 55 patients and 136 brain metastases were analyzed from January 2017 to December 2023. Tumor response was assessed based on local failure and distant brain failure, defined as tumor progression at the treated site and new brain metastases outside the GKRS-treated regions, respectively. The Kaplan-Meier method and univariate and multivariate analyses using Cox proportional hazard regression models were used to identify prognostic factors for local failure, and distant brain failure.

RESULTS:

The study found that second- and third-generation TKIs, such as afatinib and osimertinib, provided significantly better local control compared to first-generation TKIs (hazard ratio [HR] = 0.12, p = 0.017). Furthermore, tumors with exon 19 deletion demonstrated improved distant brain control compared to those with exon 21 L858R substitution (HR = 2.18, p = 0.048). These findings suggest that mutation type and TKI generation are independent prognostic factors for clinical outcomes following GKRS.

CONCLUSION:

This study suggests that both the generation of TKIs and the specific EGFR mutation subtype may influence clinical outcomes following GKRS in lung ADC patients with brain metastases. These findings may aid in stratifying patients and optimizing treatment strategies in clinical practice.

55

News (Medical) associated with Afatinib Dimaleate

16 Sep 2025

·endpoints.news

Exclusive: Fred Hutch duo's startup launches with $10M to build AI generative genomics models

If scientists run enough variations of a lab experiment, perhaps AI models could, someday, predict the results of future versions of that study. A new Seattle-based startup called Synthesize Bio believes it may be able to achieve that sooner than later, starting with gene-expression studies. Synthesize has already generated some promising results in predicting these types of lab experiments, according to a preprint published Tuesday. Synthesize will officially launch on Wednesday, its co-CEOs , Jeff Leek and Robert Bradley, exclusively told Endpoints News, as it releases its AI model, called GEM-1. The 15-employee biotech was founded in 2023 and raised a previously undisclosed $10 million seed round in October 2023, led by Madrona Ventures. Other investors include Sahsen Ventures, AI2 Incubator, Inner Loop Capital, and MD Venture Investments. Leek and Bradley came up with the idea behind Synthesize in the hallways of the Fred Hutchinson Cancer Center. Leek is the cancer center’s chief data officer, and Bradley is the scientific director of a translational data science research center. They wanted to see if biotech could follow a similar trajectory in building large AI models, similar to how companies like OpenAI and Anthropic grew large language models trained on nearly all of the internet’s data. “We felt like this is an idea where we believe it can transform how scientists go about their work,” Bradley said in an interview. The Fred Hutch duo built a model called GEM-1 over the last two years. The model is trained on tons of different gene-expression experiments that they curated and annotated from public datasets. Synthesize is already at work on the next-generation version of the model called GEM-2. “This is the worst version of the GEM model you will ever see,” Leek said. “It’s only going to get better over time.” Gene-expression experiments and single-cell studies have been a hot space within the AI bio field. Large organizations, like the Chan Zuckerberg Initiative and the Arc Institute , are championing moonshot projects that view these types of experiments as key building blocks in eventually making models of virtual cells. Virtual cells could allow more experiments traditionally done in the lab to be accurately simulated by computers. Other startups, like Noetik , Tahoe Therapeutics , and Xaira Therapeutics , are also taking their own twists on building large or rich datasets using some of these experiments. Synthesize believes its model can tackle a wider range of gene-expression experiments than the rest. To test that belief, they looked at how GEM-1’s predictions compared to real-world results. They set a cut-off date of mid-2024, training their model on experimental data in public databases before that date, and then using new experiments added after that date as tests. Overall, Synthesize’s team found GEM-1 “yielded accuracy comparable to the best-possible performance estimated by comparing the results of matched lab experiments,” according to the preprint. The preprint also found that about 95% of these new experiments were similar to those in GEM-1’s training data, meaning the model had already seen experiments that studied similar types of cells or similar perturbations. GEM-1’s predictions varied in accuracy. The model nailed the effect on gene expression of certain molecules, like the hair-loss drug finasteride and an alpha blocker called doxazosin. But predictions for other compounds were less than 50% accurate, like the HIV treatment dolutegravir or cancer drug afatinib, according to the preprint. An area of active research is working on confidence intervals, which could give users a sense of the quality of a prediction. Bradley said that’s something the broader AI field is also working on, as it’s an important problem. That could be critical in telling the finasteride and afatinib predictions apart. “Our goal is not to replace experiments,” Bradley said. “Our goal is to have a seamless blend of wet-lab work and AI experimentation. Experiments are critical. They’re always going to be the gold standard.” Instead, GEM-1 could allow scientists on finite budgets to consider more data for experiments they may not have the time or resources to run. It could also enable scientists to get a sense of results on experiments that are impossible or impractical today, Bradley said. For instance, the model could help predict a drug’s activity in tissue where you can’t take a patient’s biopsy, he said. Leek said there are blind spots, where GEM-1’s performance is wanting. That’s why they are eager to release the model openly, including free access on its website , to gain a sense of how researchers use it and its real-world performance.

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

10 Jun 2025

·www.prnewswire.com

Study Shows That Existing Drug Class May Help Patients with Skin Cancer That Resists Standard Treatments

NEW YORK, June 10, 2025 /PRNewswire/ -- Increased activity in a specific biological pathway may explain why many patients with a deadly form of skin cancer do not respond to the latest cancer treatments, a new study shows. Publishing in the journal Cancer Research online June 10, the study featured data generated from experiments with human tissues and cells from patients with advanced melanoma that were implanted into mice. Results uncovered therapeutic targets that could limit melanoma growth in patients whose cancer failed to respond to initial treatment with immune checkpoint inhibitors. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the study focused on a subgroup of melanoma patients with mutations in the neurofibromin 1 (NF1) gene. NF1 mutations — random changes in the molecular "letters" that make up this gene's DNA code — are just one type among several mutations, including those in the BRAF, NRAS, and PARP genes, that are linked to many cases of cancer, particularly melanoma. As many as 27% of melanoma patients are estimated to have NF1 mutations. While immunotherapy, which stimulates the immune system to attack cancer cells as it would an invading virus, has proved to be a successful treatment, it does not work well for more than half of NF1-mutant melanoma patients. "There is a pressing need for new drug therapies for melanoma patients with neurofibromin 1 mutations that do not respond to the latest immunotherapy, and for which there are no subsequent effective treatment options," said study lead investigator Milad Ibrahim, PhD. Ibrahim is a postdoctoral fellow in the Dr. Iman Osman Laboratory in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine. To investigate why these patients were treatment resistant, investigators examined tumor cells from 30 melanoma patients who did not respond to immunotherapy. NF1 mutations were found in 40% of these melanoma samples. The samples came from NYU Langone's extensive repository from more than 6,000 melanoma patients. Molecular testing showed that the signaling pathway built around a protein called epidermal growth factor receptor (EGFR) was more active in NF1 mutant melanoma cells than in cells with other melanoma-gene mutations. Increased EGFR activity has long been linked to abnormal cell growth in tumors and shorter survival with various cancers. The researchers also found that NF1 mutant melanoma cells depended on increased EGFR activity for survival, regardless of the presence of other mutations. Because EGFR-inhibiting drugs are already used to treat some head and neck cancers, as well as colorectal and lung cancers, researchers then tested two drugs in the class, cetuximab and afatinib, in both NF1 mutant cell cultures and cancer cell lines without NF1 mutations. After transplanting both tumor cell types into mice and treating them with these drugs, results showed that both EGFR inhibitors were effective against cells and transplanted tumors with NF1 mutations, and they had no effect on melanomas without NF1 mutations. "Our study results reveal a unique vulnerability in melanoma patients with neurofibromin 1 mutations, that an overexpression of the epidermal growth factor receptor pathway is essential for their survival and growth," said study senior investigator Iman Osman, MD. Osman is the Rudolf L. Baer Professor in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine and a member of the Perlmutter Cancer Center. Osman is also director of the interdisciplinary melanoma program and associate dean of clinical research strategy at NYU Langone. "While further tests are needed, our results support a novel approach of deploying EGFR inhibitors either alone or in combination with other immunotherapies for treatment of melanoma patients whose tumors harbor NF1 mutation," said study co-senior investigator Markus Schober, PhD. Schober is an associate professor in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine and a member of the Perlmutter Cancer Center. However, Schober says this requires further testing in a clinical trial, which the research team plans to develop. He adds that if trial findings prove successful, the team's research could provide a lifeline for many of these melanoma patients. Metastatic melanoma, as the disease is formally called, kills nearly 10,000 Americans annually. Funding for the study was provided by National Institutes of Health grants P50CA225450, U54CA263001, and P30CA016087. Additional funding support was provided by Melanoma Research Foundation grant 1287389. Besides Ibrahim, Osman and Schober, NYU Langone researchers involved in this study are co-investigators Irineu Illa-Bochaca, George Jour, Eleazar Vega-Saenz de Miera, Joseph Fracasso, Kelly Ruggles, and Jeffrey Weber. About NYU Langone Health NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked NYU Langone No. 1 out of 115 comprehensive academic medical centers across the nation for three years in a row, and U.S. News & World Report recently placed nine of its clinical specialties among the top five in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. Media Contact Shira Polan (from June 6 to June 10) 212-404-4279 [email protected] David March (after June 10) 212-404-3528 [email protected] STUDY DOI 10.1158/0008-5472.CAN-24-3904 STUDY LINK SOURCE NYU Langone Health System WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyClinical StudyClinical Result

100 Deals associated with Afatinib Dimaleate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09733	Afatinib Dimaleate	L01XE13	DB08916

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
metastatic non-small cell lung cancer	United States	Boehringer Ingelheim GmbH	12 Jan 2018
Non-Small Cell Lung Cancer	China	Boehringer Ingelheim International GmbH	21 Feb 2017
EGFR positive non-small cell lung cancer	Japan	Nippon Boehringer Ingelheim Co., Ltd.	17 Jan 2014
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Australia	Boehringer Ingelheim Pty Ltd.	07 Nov 2013
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Australia	Boehringer Ingelheim Pty Ltd.	07 Nov 2013
Squamous non-small cell lung cancer	European Union	Boehringer Ingelheim International GmbH	25 Sep 2013
Squamous non-small cell lung cancer	Iceland	Boehringer Ingelheim International GmbH	25 Sep 2013
Squamous non-small cell lung cancer	Liechtenstein	Boehringer Ingelheim International GmbH	25 Sep 2013
Squamous non-small cell lung cancer	Norway	Boehringer Ingelheim International GmbH	25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer	European Union	Boehringer Ingelheim International GmbH	25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer	Iceland	Boehringer Ingelheim International GmbH	25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer	Liechtenstein	Boehringer Ingelheim International GmbH	25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer	Norway	Boehringer Ingelheim International GmbH	25 Sep 2013
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	United States	Boehringer Ingelheim GmbH	12 Jul 2013
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	United States	Boehringer Ingelheim GmbH	12 Jul 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Singapore	Boehringer Ingelheim Pharma GmbH & Co., KG	22 Dec 2014
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Singapore	Boehringer Ingelheim International GmbH	22 Dec 2014
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	South Korea	Boehringer Ingelheim Pharma GmbH & Co., KG	22 Dec 2014
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	South Korea	Boehringer Ingelheim International GmbH	22 Dec 2014
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Boehringer Ingelheim GmbH	30 Sep 2013
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Hong Kong	Boehringer Ingelheim GmbH	30 Sep 2013
Advanced Lung Non-Small Cell Carcinoma	Phase 3	India	Boehringer Ingelheim GmbH	30 Sep 2013
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Singapore	Boehringer Ingelheim GmbH	30 Sep 2013
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	Boehringer Ingelheim GmbH	30 Sep 2013
Diarrhea	Phase 3	United States	Boehringer Ingelheim GmbH	01 Apr 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2025	Phase 2	metastatic non-small cell lung cancer EGFR-mutant	91	Afatinib	rdqoafozrz(aipmwbcmhr): HR = 0.49 (95.0% CI, 0.25 - 0.94), P-Value = 0.035	Positive	09 Sep 2025
				Afatinib (Primary tumor resection with or without radiotherapy)
NCT04795245 (Pubmed \| Future Oncol)	Not Applicable	Non-squamous non-small cell lung cancer \| Advanced Lung Adenocarcinoma	-	Afatinib	bkkscyhrnf(ehkcozdcii) = splyamsyiy iaqnvjikxb (lmrrlxcopn ) View more	-	03 Jul 2025
NCT02191891 (CTgov)	Phase 1	EGFR-mutated non-small Cell Lung Cancer	32	Afatinib+Xentuzumab (Xentuzumab + Afatinib 30 Milligram (mg) - Part A)	djmjlzonfh = tapwrdbhxc slnrhmtkaj (sgehqwzlcc, wbxaiueakg - nqxbzdlkna)	-	25 Jun 2025
				Afatinib+Xentuzumab (Xentuzumab + Afatinib 40 mg - Part A)	djmjlzonfh = exbcjrvxur slnrhmtkaj (sgehqwzlcc, efvlfkaogt - pwoohpjxiz)
NCT05516589 (neoCHANCE-2, ASCO2025)	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant \| Adjuvant	40	Tislelizumab + TP + Afatinib	ukttnhpian(gtyxdyzcah) = 100% ufiscfwrpn (qclciuxxib ) View more	Positive	30 May 2025
				Adjuvant Tislelizumab
ACHILLES/TORG1834 (ASCO2025)	Phase 3	EGFR-mutated non-small Cell Lung Cancer	109	Afatinib 30 mg	mrnvcfojwj(xrdjxecjfs) = htgpiieeik jcejmwcwtr (wpkcjypdkj ) View more	Positive	30 May 2025
				Platinum + Pemetrexed	mrnvcfojwj(xrdjxecjfs) = wuisvlvdhq jcejmwcwtr (wpkcjypdkj ) View more
NEJ025B (ASCO2025)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer Second line EGFR mutations \| p53 mutations \| MET gene amplification	35	Afatinib + Carboplatin + Pemetrexed	ogdyerawno(huqkadcvzt) = hguzbvsbej impzppjynz (iifnahtkhm, 39.3 - 71.5) View more	Positive	30 May 2025
JPRN-jRCTs031190221 (Heat on Beat, ASCO2025)	Phase 2	First line Th7R \| Th2	95	Afatinib	iuuhiucuyd(efshojlvow) = droszutuqn ujqgtlbwwh (pyixtznmuc, 39.4 - 67.7) View more	Positive	30 May 2025
				Osimertinib	iuuhiucuyd(efshojlvow) = zfxwbppegr ujqgtlbwwh (pyixtznmuc, 42.2 - 70.1) View more
NCT03088059 (EORTC-HNCG-1559, ASCO2025)	Phase 2	Squamous Cell Carcinoma of Head and Neck EGFR \| HER2 \| PTEN ... View more	250	Afatinib in pts with EGFR amp/mut and/or HER2 amp/mut and/or PTEN high	mlkwfcnysd(pkdkpgccui) = kukgdnifoo psglltpdym (gzcsdzqtzj )	Negative	30 May 2025
				Afatinib in cetuximab-naïve pts	mlkwfcnysd(pkdkpgccui) = lmhlfyqsda psglltpdym (gzcsdzqtzj )
NCT02122172 (CTgov)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma \| Ureteral Neoplasms \| Recurrent Bladder Cancer ... View more	32	laboratory biomarker analysis+afatinib dimaleate	krsivqyayu = ywnjnmjina ugmhhkxatt (exbtdcutnf, htxkciwxaz - khrwaeurls) View more	-	25 Apr 2025
JPRN-jRCTs031180175 (ACHILLES \| TORG1834, Pubmed \| J Clin Oncol) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	109	Afatinib	eybjrdqlpw(wusymaodmq) = wsabpukxai unajtqyylf (xdjvtkpdyo ) View more	Positive	16 Apr 2025
				Platinum + Pemetrexed	eybjrdqlpw(wusymaodmq) = mzhsyxrrum unajtqyylf (xdjvtkpdyo )