更新于：2024-09-06
Sevabertinib
更新于：2024-09-06
概要
基本信息
药物类型 小分子化药 |
别名 BAY 2927088、BAY-2927088 |
作用机制 EGFR exon 20抑制剂(EGFR exon 20突变抑制剂)、HER2 exon 20抑制剂(ERBB2-受体蛋白酪氨酸激酶20外显子突变抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (美国)、突破性疗法 (中国) |
关联
9
项与 Sevabertinib 相关的临床试验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.
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.
开始日期2024-08-22 |
申办/合作机构 |
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.
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.
开始日期2024-04-17 |
申办/合作机构 |
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.
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.
开始日期2024-04-10 |
申办/合作机构 |
100 项与 Sevabertinib 相关的临床结果
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100 项与 Sevabertinib 相关的转化医学
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100 项与 Sevabertinib 相关的专利（医药）
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25
项与 Sevabertinib 相关的新闻（医药）2024-08-31
·拜耳中国
首例患者入组研究药物BAY 2927088治疗携带HER-2激活突变的晚期NSCLC初治患者的III期SOHO-02试验。
I/II期SOHO-01试验数据已入选世界肺癌大会的主席研讨会。
拜耳宣布，全球III期SOHO-02试验已完成首例患者入组，这是一项开放标签、随机、多中心临床试验，旨在评估研究药物BAY 2927088，在携带HER2激活突变的晚期非小细胞肺癌（NSCLC）患者中作为一线治疗的有效性和安全性。
除SOHO-02试验以外，在携带HER2（ERBB2）激活突变的不可切除或转移性NSCLC，并且此前接受过系统性治疗的成人患者中，也在评估研究药物BAY 2927088作为二线治疗的潜力。SOHO-01 I/II期试验的最新结果将于2024年9月9日，在圣地亚哥举行的世界肺癌大会（WCLC）主席研讨会上发表。
Christian Rommel 博士
拜耳处方药事业部研发负责人
“我们对精准医疗的承诺不仅仅是一个承诺，而是一项使命，针对肺癌中常见的突变类型——HER2突变型NSCLC人群，解决其未满足的医疗需求。通过推进创新研究，我们致力于提高罹患此种毁灭性疾病人群的生存率。这一努力突显了我们为有直接需要的人群，开拓精准和个性化医疗解决方案的承诺。”
研究药物BAY 2927088来源于拜耳与美国马萨诸塞州剑桥市麻省理工学院和哈佛大学博德研究所的战略研究联盟。
肺癌是全球癌症相关死亡的主要原因。目前，对于携带HER2激活突变的NSCLC患者，尚没有批准的靶向一线疗法。
BAY 2927088用于二线治疗于2024年2月获得美国食品药物监督管理局（FDA）的突破性疗法认定。2024年6月，中国国家药品监督管理局药品审评中心（CDE）亦授予试验药物BAY 2927088治疗相同患者人群的突破性治疗品种认定。
SOHO-02是一项全球III期、开放标签、随机、多中心临床试验，评估研究药物BAY 2927088作为携带HER2激活突变的晚期非小细胞肺癌（NSCLC）成年患者一线治疗的有效性和安全性。受试者被随机分配到试验药物BAY 2927088或目前的标准治疗组（顺铂/卡铂+培美曲塞+帕博利珠单抗）。研究的主要终点是通过盲态独立中心评估的无进展生存期（PFS）。其他终点包括总体缓解率（ORR）、缓解持续时间（DoR）和评估试验药物BAY 2927088的安全性。更多信息请访问https://clinicaltrials.gov/study/NCT06452277。
BAY 2927088是一款尚未获得任何国家卫生监管机构批准用于治疗任何适应症的试验药物。目前，它正在被评估作为携带HER2激活突变NSCLC患者的潜在新型靶向治疗选择。BAY 2927088是一种口服可逆酪氨酸激酶抑制剂（TKI），可有效抑制突变型人表皮生长因子受体2（HER2），包括HER2外显子20插入和HER2点突变，以及表皮生长因子受体（EGFR），对突变型EGFR较野生型EGFR具有高选择性。
NSCLC是肺癌中最常见的类型，占85%以上。2%至4%的晚期NSCLC中发现HER2激活突变。80%的非小细胞肺癌在诊断时已进展至晚期，使得治疗更加困难。
拜耳公司秉承“科技创造美好生活”，持续优化创新型产品组合。我们拥有开发创新药物的热情和决心，帮助改善和延长癌症患者生命。拜耳肿瘤业务部门目前包括涵盖多种适应症的多款肿瘤产品，以及在各个临床开发阶段的几种其他化合物。我们在肿瘤内部信号通路、靶向放射性核素治疗和下一代免疫肿瘤学等领域拥有丰富的专业知识。我们正在将前列腺癌治疗从早期推进至疾病转移阶段，目标是在减轻副作用的同时延长生存期。拜耳的另一个重点是肿瘤精准治疗，包括一款已获批的TRK抑制剂，专门用于治疗存在NTRK基因融合的肿瘤，该基因是肿瘤生长和扩散的致癌驱动因子。
拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。
内容来源于网络，如有侵权，请联系删除。
突破性疗法临床结果
2024-08-29
·药明康德
▎药明康德内容团队编辑
拜耳（Bayer）公司今日宣布，首例患者已入组全球性3期临床试验SOHO-02。这是一项开放标签、随机、多中心的临床试验，旨在评估在研药物BAY 2927088作为晚期非小细胞肺癌（NSCLC）患者一线治疗的疗效和安全性，这些患者的肿瘤存在激活性人类表皮生长因子受体2（HER2）突变。
BAY 2927088是一种口服、可逆性酪氨酸激酶抑制剂（TKI），能够强效抑制突变的HER2，包括HER2外显子20插入突变和HER2点突变，同时也能抑制表皮生长因子受体（EGFR）。该疗法源于拜耳与美国Broad研究所的战略研究合作。它在今年2月已获得美国FDA授予的突破性疗法认定，在今年6月也获得了中国国家药品监督管理局药品审评中心授予的突破性疗法认定。
SOHO-02是一项全球性、开放标签、随机、多中心3期临床试验，旨在评估BAY 2927088作为晚期NSCLC成人患者一线治疗的疗效和安全性，这些患者的肿瘤携带激活性HER2突变。参与者将被随机分配到BAY 2927088组或现行标准治疗组（顺铂/卡铂+培美曲塞+帕博利珠单抗）。研究的主要终点是由盲态、独立的中央评审机构测量的无进展生存期（PFS）。其他终点包括总缓解率（ORR）、缓解持续时间（DoR）及BAY 2927088的安全性评估。
除SOHO-02试验外，拜耳还在评估BAY 2927088作为二线治疗的潜力，针对肿瘤携带激活性HER2突变且已接受过全身治疗的无法切除或转移性NSCLC成人患者。1/2期临床试验SOHO-01的最新结果将于2024年9月9日举行的世界肺癌大会（WCLC）主席研讨会上公布。
在今年美国临床肿瘤学会（ASCO）年会上公布的SOHO-01的结果显示，在33名可评估疗效的患者中：23名患者获得缓解，ORR为70%，5名患者（15%）病情稳定，疾病控制率为82%，中位无进展生存期为8.1个月。
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参考资料：
[1] Bayer starts Phase III Trial in Non-Small Cell Lung Cancer (NSCLC). Retrieved August 29, 2024, from https://www.businesswire.com/news/home/20240829270284/en
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突破性疗法临床结果ASCO会议临床3期
2024-08-29
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
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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.
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期非小细胞肺癌 | 临床3期 | 美国 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 日本 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 奥地利 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 比利时 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 巴西 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 保加利亚 | 2024-08-22 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 加拿大 | 2024-08-22 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | 33 | 淵鏇窪鏇膚襯遞糧製願(衊醖觸繭艱鹹衊製鹽廠) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). 廠餘淵簾夢鬱鑰選遞觸 (鏇廠願簾膚壓艱艱獵積 ) | 积极 | 2024-06-02 | |||
临床1期 | HER2 20号外显子插入突变非小细胞肺癌 HER2 Expression | 76 | 鹽齋築憲壓顧餘觸簾簾(齋餘構顧廠遞廠範網夢) = 構簾觸鏇夢鹹鹽簾網醖 簾壓衊觸憲膚壓簾網廠 (糧襯艱網膚鏇憲獵鹹築 ) 更多 | 积极 | 2023-10-22 | ||
(pts with HER2 ex20ins mutant disease) | 遞窪願窪選顧鏇糧網顧(窪鏇選膚構繭衊糧遞膚) = 選餘淵選簾鹽醖餘範製 醖網夢觸齋廠齋簾製築 (醖餘艱鹹鏇蓋壓鬱齋廠 ) |
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