EGFR C797S inhibitors(Epidermal Growth Factor Receptor C797S inhibitors), EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors), HER2 exon 20 inhibitors(ERBB2 Exon 20 Mutation inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Advanced Lung Non-Small Cell CarcinomaHER2 mutant non-small cell lung cancerEGFR-mutated non-small Cell Lung Cancer+ [1]

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Bayer AG

Bayer Healthcare Co., Ltd.

Inactive Organization

The Broad Institute, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (CN), Breakthrough Therapy (US)

Clinical Trials associated with Sevabertinib

NCT06452277 / RecruitingPhase 3

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Start Date28 Aug 2024

Sponsor / Collaborator

Bayer AG

NCT06360211 / CompletedPhase 1

A Phase 1, Open Label, Fixed Sequence, Crossover Study to Investigate the Effect of BAY 2927088 on the Pharmacokinetics of Midazolam in Healthy Participants

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.
In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.
BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.
The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:
* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood
The study will have 3 treatment periods:
Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088
Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.
Participants will visit the study clinic:
* More than/at least once, within 2 to 28 days before the treatment starts
* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment
* Once, within 7 to 10 days after they finish treatment for a health checkup
During the study, the doctors and their study team will:
* do physical examinations
* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Start Date17 Apr 2024

Sponsor / Collaborator

Bayer AG

NCT06348888 / CompletedPhase 1

A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.
Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.
In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.
BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.
The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine
Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
The study will have 2 treatment groups.
In Group 1, participants will take:
BAY2927088 as a single dose on Days 1 and 8.
Itraconazole once daily on Days 5 to 11.
In Group 2, participants will take:
BAY2927088 as a single dose on Days 1 and 14.
Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.
Participants will visit the study clinic:
at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up
During the study, the doctors and their study team will:
perform physical examinations
collect blood samples from the participants to measure the levels of BAY2927088
check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Start Date10 Apr 2024

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Sevabertinib

100 Translational Medicine associated with Sevabertinib

100 Patents (Medical) associated with Sevabertinib

News (Medical) associated with Sevabertinib

09 Sep 2024

·www.fiercebiotech.com

Boehringer and Bayer's oral meds deliver in early HER-2 mutant lung cancer studies

Both drugs are now in phase 3 trials, with Boehringer Ingelheim’s set to wrap up in May 2028 and Bayer’s expected to finish by the end of 2026. Some patients with non-small cell lung cancer (NSCLC) have mutations in a gene called human epidermal growth factor receptor 2 (HER2), which drives their disease progression. Treatment options are limited for patients with this rare mutation, with only AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu approved to target it.At the 2024 World Conference on Lung Cancer in San Diego, two rivals shared data on new oral drugs looking to challenge Enhertu’s dominance. Boehringer Ingelheim’s zongertinib and Bayer’s BAY 2927088 elicited objective response rates of 66.7% and 72.1% in their respective phase 1b and phase 1/2 trials, the companies said Monday.Both drugs target HER2, which is a tyrosine kinase embedded in the membranes of cells, while Bayer’s drug also targets mutations in epidermal growth factor receptors. Both trials enrolled patients with HER2-mutated lung cancer. In the Beamion LUNG-1 trial, BI's zongertinib shrank tumors in 94% of all patients. In the study, 17% of patients who received the 120-mg dose and 19% who received the 240-mg dose experienced adverse events of grade 3 or higher, with the most common side effects being mild, such as diarrhea and rash. Boehringer will present progression-free survival and duration of response data later this year, according to the release. In Beamion LUNG-1, 3% of patients had to discontinue treatment with zongertinib due to the side effects, the release said.Zongertinib also controlled the asymptomatic brain cancer of patients whose cancer had metastasized, with almost three-fourths of these patients given 120 mg showing disease control, as determined by tumor response and progression, according to BI. Brain metastases occur in up to 30% of patients with HER2-mutated NSCLC, according to the press release.In the SOHO-1 trial, one patient given BAY 2927088 had their cancer completely disappear. The median duration of response in the study was 8.7 months, and median progression-free survival came in at 7.5 months. Diarrhea was again the most common side effect; three patients (6.8%) had side effects that led to them stopping treatment.Both drugs are now in phase 3 trials, with both set to wrap up in May 2028.While Enhertu is an antibody-drug conjugate, both zongertinib and BAY 2927088 are small molecules with a different mechanism of action, meaning they could potentially be used in combination with Enhertu. "One can imagine that the ADC drug binds to the membrane, and then the TKI goes into the ATP-binding pocket [of the protein]," Xiuning Le, M.D., Ph.D., an oncologist at the University of Texas MD Anderson Cancer Center and leader of the Bayer study, said in a press conference. "And they have a truly synergistic, on-target, deep inhibition so that tumor shrinkage and duration can be fantastic." A combination like that still needs to be tested preclinically and clinically, she added.As the dueling pharmas gear up to potentially take on Enhertu, AstraZeneca and Daiichi Sankyo have been working to expand their drug’s dominance across different cancer types. Enhertu brought in $893 million in the second quarter of 2024, a 1.6% increase from the first quarter.

ADCPhase 3Clinical ResultPhase 1

09 Sep 2024

·www.businesswire.com

New results from the Investigational agent BAY 2927088 in HER2-mutant non-small cell lung cancer (NSCLC) presented at WCLC

BERLIN--( BUSINESS WIRE )--Bayer announced encouraging results from the expansion part of the ongoing Phase I/II SOHO-01 study evaluating the safety and preliminary efficacy of BAY 2927088 in advanced HER2-mutant non-small cell lung cancer (NSCLC). Data were presented during the Presidential Symposium at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, taking place in San Diego, United States, from September 7-10, 2024. “The encouraging results from the expansion phase of the SOHO-01 trial demonstrate the potential of this targeted therapy to advance outcomes for patients with HER2-mutant NSCLC, a type of lung cancer with limited treatment options and poor prognosis," said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “The development of BAY 2927088 underscores our ongoing commitment in lung cancer and our continued drive to develop precise and personalized healthcare solutions in disease areas with the highest unmet needs.” "HER2-mutant NSCLC is a challenging disease that can predominantly affect individuals who are young and never smoked a cigarette. Given the current lack of therapeutic options, there is an immediate need for effective, manageable treatments,” said SOHO-01 lead trialist, Xiuning Le, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX. “BAY 2927088 showed promising preliminary efficacy in both response rate and duration, and a manageable safety profile, which emphasizes the importance of ongoing innovation to elevate the standard of care." The objective of the expansion phase of the study was to determine the safety, tolerability, and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC. These data support the ongoing investigation of BAY 2927088 in patients with advanced NSCLC harboring HER2 mutations. Just recently Bayer announced that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations. Detailed Results from SOHO-01 SOHO-01 is an ongoing, open-label, multicenter Phase I/II study. Results from patients with advanced NSCLC harboring a HER2-activating mutation with disease progression after ≥1 systemic therapies for advanced disease, and who are naïve to HER2-targeted therapy were presented. In the trial, patients received oral BAY 2927088 20 mg twice daily. Forty-three out of forty-four patients enrolled were evaluable for efficacy, with a confirmed objective response rate (ORR) of 72.1% (n=31; 95% CI 56.3, 84.7) including 1 complete response (2.3%). Median duration of response (DOR) and progression-free survival (PFS) were 8.7 months (95% CI 4.5, not estimable) and 7.5 months (95% CI 4.4, 12.2), respectively. In patients with HER2 YVMA insertions, the most frequent mutation, ORR was 90.0%, DoR was 9.7 months, and PFS was 9.9 months. The safety profile of BAY 2927088 was found to be manageable, and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 95.5% of patients, with grade 3 TRAEs reported in 40.9%. Diarrhea was the most common TRAE (86.4%, 25.0% grade 3), followed by rash (43.2% grade 1 or 2) and paronychia (25.0% grade 1 or 2). Three patients (6.8%) discontinued due to TRAEs. About BAY 2927088 BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. About Breakthrough Therapy Designation This Breakthrough Therapy designation for BAY 2927088 is supported by preliminary clinical evidence from the Phase I/II, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR. The Breakthrough Therapy designation is a process designed to expedite the development and review of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over available treatment options. About Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com Find more information at https://pharma.bayer.com © 2024 Bayer BAYER, the Bayer Cross is registered trademarks of Bayer. Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Clinical ResultBreakthrough TherapyPhase 3

29 Aug 2024

·www.businesswire.com

Bayer starts Phase III Trial in Non-Small Cell Lung Cancer (NSCLC)

BERLIN--( BUSINESS WIRE )--Bayer announced today that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations. Beyond the SOHO-02 trial, investigational agent BAY 2927088 is also being assessed for its potential as a second-line therapy in adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. Late-breaking results from the phase I/II SOHO-01 trial will be presented in the presidential symposium at the World Conference on Lung Cancer (WCLC) in San Diego on Monday, September 9th, 2024. “ Our commitment to precision medicine is not just a promise but a mission to address the critical unmet needs of individuals battling HER2-mutant NSCLC, a variant of the most prevalent form of lung cancer,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “ By advancing innovative research, we are dedicated to improving survival rates for those affected by this devastating disease. This endeavor underscores our commitment to pioneering precise and personalized healthcare solutions for those in direct need.” Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. Lung cancer is the leading cause of cancer-related deaths worldwide. Currently there are no approved targeted first-line therapies for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 has received Breakthrough Therapy designation in the second-line setting from the U.S. Food and Drug Administration (FDA) in February 2024. In June 2024, the Center for Drug Evaluation (CDE) in China also granted investigational agent BAY 2927088 Breakthrough Therapy designation for the same patient population. About the SOHO-02 Study SOHO-02 is a global Phase III, open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy for adult patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations. Participants will be randomized to either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival (PFS) measured by a blinded, independent, central review. Additional endpoints include overall response rate (ORR), duration of response (DoR) and evaluating the safety of investigational agent BAY 2927088. More information can be found at https://clinicaltrials.gov/study/NCT06452277 . About Investigational Agent BAY 2927088 BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. About Non-Small Cell Lung Cancer (NSCLC) NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at www.pharma.bayer.com Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on Twitter: @BayerPharma sg (2024-0113E) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Phase 3Breakthrough Therapy

100 Deals associated with Sevabertinib

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	JP	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	AR	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	AU	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	AT	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	BE	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	BR	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	BG	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CA	Bayer AG	28 Aug 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05099172 (SOHO-01, ASCO2024) Manual	Phase 1/2	HER2 mutant non-small cell lung cancer Second line \| Third line HER2-activating mutation	33	BAY 2927088	epkysptnna(mijhjinrll) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). rhjjpdyaqj (misbymzbxh )	Positive	02 Jun 2024
NCT05099172 (ESMO2023) Manual	Phase 1	HER2 ex20ins mutation in non-small cell lung cancer HER2 Expression	76	BAY 2927088	wthktltnre(qwtaxgjsdt) = cuesunkgao wzwpmxacox (ujpvqwduod ) View more	Positive	22 Oct 2023
NCT05099172 (ESMO2023) Manual	Phase 1		76	BAY 2927088 (pts with HER2 ex20ins mutant disease)	uagxxcrkfu(btagdgpexf) = vlckykfhzc dxefuntaku (dyrijziwxc )	Positive	22 Oct 2023

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