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RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).1.
新泽西州拉瑞坦(RARITAN),2024年9月17日/PRNewswire/--强生公司(纽约证券交易所:JNJ)今天宣布,美国食品和药物管理局(FDA)批准RYBREVANT®(阿米万塔单抗vmjw)联合标准治疗化疗(卡铂和培美曲塞)治疗患有表皮生长因子受体(EGFR)外显子19缺失(ex19del)或L858R替代突变的局部晚期或转移性非小细胞肺癌(NSCLC)的成年患者,其疾病在用EGFR酪氨酸激酶抑制剂(TKI)治疗时或治疗后进展。
'RYBREVANT plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib, in the first line,' said Martin Dietrich*, M.D., Ph.D., Oncologist, Cancer Care Centers of Brevard. 'This multitargeted combination extended progression-free survival and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients.'.
布雷瓦德癌症护理中心肿瘤科医生、医学博士马丁·迪特里希(MartinDietrich*)说,莱布列万特联合化疗可能会在第一线解决对第三代EGFR-TKIs(如osimertinib)最常见的治疗耐药机制与单独化疗相比,这种多靶点组合延长了无进展生存期并改善了总体反应,为患者提供了重要而有效的新二线选择。”。
The five-year survival rate is less than 20 percent for all people with advanced EGFR-mutated NSCLC.2,3 Acquired resistance mechanisms after TKI monotherapy are diverse and polyclonal, making targeted therapy at progression more difficult, thus limiting the efficacy of targeted therapies at progression.4,5 Adding immunotherapy to chemotherapy has also failed to demonstrate clinically meaningful improvements.6,7.
所有晚期EGFR突变NSCLC患者的五年生存率均低于20%.2,3 TKI单药治疗后获得性耐药机制多种多样且多克隆,使得进展期靶向治疗更加困难,从而限制了靶向治疗的疗效进展[4,5]。在化疗中加入免疫治疗也未能证明临床上有意义的改善[6,7]。
'The progression-free survival benefits seen in the MARIPOSA-2 study are exciting,' said Andrea Ferris**, President and CEO, LUNGevity Foundation. 'It is good to see new therapeutic options like the combination of RYBREVANT and chemotherapy helping to address unmet needs impacting individuals with EGFR-mutated lung cancer, with the potential for positive change, which gives hope to more patients and their families.'.
“在MARIPOSA-2研究中看到的无进展生存益处令人兴奋,”肺活量基金会总裁兼首席执行官安德里亚·费里斯**说很高兴看到新的治疗选择,如RYBREVANT和化疗的结合,有助于解决影响EGFR突变肺癌患者的未满足需求,并有可能产生积极变化,这为更多患者及其家人带来了希望。”。
The FDA approval is based on results from the Phase 3 MARIPOSA-2 (NCT04988295) study evaluating the efficacy and safety of RYBREVANT® in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations after disease progression on or after osimertinib.1 Results showed RYBREVANT® plus chemotherapy reduced the risk of disease progression or death (progression-free survival [PFS]) by 52 percent vs.
FDA的批准是基于第3阶段MARIPOSA-2(NCT04988295)研究的结果,该研究评估了RYBREVANT®联合化疗治疗局部晚期或转移性非小细胞肺癌(EGFR ex19del或L858R替代突变)的成年患者在osimertinib上或之后疾病进展后的疗效和安全性。结果显示,RYBREVANT®联合化疗可将疾病进展或死亡风险(无进展生存期[PFS])降低52%。
chemotherapy alone, the study's primary endpoint.1 The median PFS for patients receiving RYBREVANT® plus chemotherapy was 6.3 months, compared to 4.2 months for chemotherapy alone.1 Additionally, RYBREVANT® plus chemotherapy showed a confirmed overall response rate (ORR) of 53 percent compared to 29 percent with chemotherapy alone.1.
单独化疗是该研究的主要终点[1]。接受RYBREVANT®加化疗的患者的中位PFS为6.3个月,而单独化疗为4.2个月[1]。此外,RYBREVANT®加化疗的确诊总有效率(ORR)为53%,而单独化疗为29%。
Amivantamab-vmjw (RYBREVANT®) in combination with chemotherapy is the only National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Category 1 treatment option for patients with EGFR-mutated NSCLC progressing on osimertinib who are symptomatic with multiple lesions.8 †‡ .
Amivantamab vmjw(RYBREVANT®)联合化疗是唯一的国家综合癌症网络®(NCCN®)肿瘤学临床实践指南(NCCN Guidelines®)1类治疗选择,用于EGFR突变的NSCLC进展为osimertinib的患者,症状为多发性病变。8†‡。
'This milestone reinforces RYBREVANT as an important treatment option for patients with EGFR-mutated NSCLC who continue to face high unmet needs after disease progression on or after TKI therapy,' said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine.
强生创新医学公司实体瘤临床开发副总裁Kiran Patel医学博士说:“这一里程碑强化了RYBREVANT作为EGFR突变的非小细胞肺癌患者的重要治疗选择,这些患者在TKI治疗或治疗后疾病进展后仍面临高度未满足的需求。”。
'Patients need and deserve effective, targeted approaches across all lines of therapy. With RYBREVANT-based regimens, we are bringing potential new standards of care to the nearly 30,000 patients diagnosed with EGFR-mutated NSCLC in the United States each year.'.
“患者需要并且应该在所有治疗领域采取有效的、有针对性的方法。通过基于RYBREVANT的方案,我们每年为美国近30000名被诊断患有EGFR突变的NSCLC的患者带来潜在的新护理标准。”。
The safety profile of RYBREVANT® in combination with chemotherapy was consistent with the established profiles of the individual treatments. Permanent discontinuation of RYBREVANT® due to adverse reactions occurred in 11 percent of patients.1
RYBREVANT®联合化疗的安全性与个体治疗的既定概况一致。11%的患者因不良反应而永久停用RYBREVANT®。1
MARIPOSA-2 Publications & PresentationsResults from MARIPOSA-2 were first presented in a Presidential Symposium at the European Society of Medical Oncology (ESMO) 2023 Congress (Abstract #LBA15) and simultaneously published in the Annals of Oncology.9
MARIPOSA-2出版物和介绍MARIPOSA-2的结果首次在2023年欧洲肿瘤内科学会(ESMO)大会(摘要#LBA15)的总统研讨会上发表,并同时发表在《肿瘤学年鉴》上
Regulatory MilestonesThis approval marks the third new indication for RYBREVANT® this year, following the August 20, 2024, U.S. FDA approval announcement of RYBREVANT® in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, based on the Phase 3 MARIPOSA study, and the March 1, 2024, U.S.
监管里程碑这一批准标志着今年RYBREVANT®的第三个新适应症,继美国2024年8月20日之后。S、 根据第3阶段MARIPOSA研究和2024年3月1日的美国FDA批准宣布RYBREVANT®联合LAZCLUZE™(lazertinib)用于局部晚期或转移性非小细胞肺癌EGFR外显子19缺失或L858R替代突变的成年患者的一线治疗。
FDA approval announcement of RYBREVANT® in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, based on the Phase 3 PAPILLON study.1.
美国 FDA 批准 RYBREVANT® 联合化疗(卡铂-培美曲塞)一线治疗表皮生长因子受体外显子 20 插入突变的局部晚期或转移性 NSCLC 患者。
On June 17, 2024, Johnson & Johnson also announced the submission of a Biologics License Application to the U.S. FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT®.
2024年6月17日,强生公司还宣布向美国食品和药物管理局提交生物制剂许可证申请,申请将阿米万塔单抗和重组人透明质酸酶固定组合用于皮下给药(SC amivantamab),用于所有目前批准或提交的静脉注射(IV)RYBREVANT®适应症。
This application is based on the Phase 3 PALOMA-3 study, with preliminary results which showed a five-fold reduction in infusion-related reactions (IRR) with a five-minute administration of SC amivantamab.10 Longer overall survival (OS), PFS and duration of response (DOR) were also observed with SC amivantamab.10 On August 14, 2024, the U.S.
该应用基于3期PALOMA-3研究,初步结果显示,给予SC阿米万塔单抗5分钟后,输注相关反应(IRR)降低了5倍.10总生存期(OS),PFS和反应持续时间(DOR)也在2024年8月14日在美国SC阿米万塔单抗中观察到。
FDA designated this application for Priority Review..
FDA指定该申请进行优先审查。。
About the MARIPOSA-2 Study
关于MARIPOSA-2研究
MARIPOSA-2 (NCT04988295), which enrolled 657 patients, is a randomized, open-label Phase 3 study evaluating the efficacy and safety of two combination regimens of RYBREVANT® (with and without LAZCLUZE™) and chemotherapy.11 Patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib were randomized to treatment with RYBREVANT® plus chemotherapy, RYBREVANT® plus chemotherapy with LAZCLUZE™ or chemotherapy alone.11 The dual primary endpoint was used to compare the PFS (using RECIST v1.1 guidelines§) as assessed by blinded independent central review (BICR) for each experimental arm to chemotherapy alone.11 Secondary endpoints included objective response as assessed by BICR, OS, DOR, time to subsequent therapy, PFS2 and intracranial PFS.11.
MARIPOSA-2(NCT04988295)招募了657名患者,是一项随机,开放标签的3期研究,评估了两种联合方案(有和没有LAZCLUZE TM)和化疗的疗效和安全性.11局部晚期或转移性EGFR ex19del或L858R替代NSCLC患者在用osimertinib治疗时或治疗后有疾病进展,随机接受RYBREVANT®加化疗,RYBREVANT®加LAZCLUZE™化疗或单独化疗的治疗.11双主要终点用于比较盲法评估的PFS(使用RECIST v1.1指南§)ED独立中央审查(BICR)为每个实验组单独进行化疗[11]。次要终点包括通过BICR,OS,DOR,后续治疗时间,PFS2和颅内PFS评估的客观反应。
About RYBREVANT®
关于[UNK]RYBREVANT®
RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe, and in other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.1 In the subcutaneous formulation, amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology..
RYBREVANT®(amivantamab vmjw)是一种靶向EGFR并具有免疫细胞导向活性的全人双特异性抗体,已在美国获得批准。S、 ,欧洲和世界其他市场,作为单一疗法,用于治疗具有EGFR外显子20插入突变的局部晚期或转移性NSCLC的成年患者,通过FDA批准的测试检测,其疾病在铂类化疗时或之后进展。1在皮下制剂中,阿米万塔单抗与重组人透明质酸酶PH20(rHuPH20),Halozyme的ENHANZE®药物递送技术共同配制。。
RYBREVANT® is approved in the U.S., Europe, and in other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test..
RYBREVANT®在美国,欧洲和世界其他市场被批准与化疗(卡铂和培美曲塞)联合用于一线治疗具有EGFR外显子20插入突变的局部晚期或转移性NSCLC的成年患者,这是通过FDA批准的测试检测到的。。
RYBREVANT® is approved in the U.S. in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. A marketing authorization application (MAA) and type II extension of indication application were submitted to the EMA seeking approval of LAZCLUZE™ in combination with RYBREVANT® based on the MARIPOSA study..
RYBREVANT®在美国被批准与LAZCLUZE™(lazertinib)联合用于一线治疗具有EGFR外显子19缺失或L858R替代突变的局部晚期或转移性NSCLC的成年患者,这是通过FDA批准的测试检测到的。根据MARIPOSA研究,向EMA提交了营销授权申请(MAA)和II型适应症扩展申请,寻求LAZCLUZE™与RYBREVANT®联合使用的批准。。
In November 2023, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT® in combination with chemotherapy for the treatment of patients with EGFR-mutated NSCLC who progressed on or after osimertinib based on the MARIPOSA-2 study. This indication was approved in Europe in August 2024..
2023年11月,强生公司向美国FDA提交了一份补充生物制剂许可证申请(sBLA),用于RYBREVANT®联合化疗治疗EGFR突变的非小细胞肺癌患者,这些患者根据MARIPOSA-2研究在osimertinib上或之后进展。该适应症于2024年8月在欧洲获得批准。。
In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT® in combination with LAZCLUZE™ for all currently approved or submitted indications of IV RYBREVANT® in certain patients with NSCLC. In August 2024, the U.S. FDA designated this application for Priority Review. .
2024年6月,强生公司向美国FDA提交了一份BLA,用于RYBREVANT®联合LAZCLUZE™的皮下制剂,用于某些NSCLC患者目前批准或提交的所有静脉注射RYBREVANT®适应症。2024年8月,美国FDA指定该申请进行优先审查。。
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC¶ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include:
针对NSCLC的NCCN肿瘤学临床实践指南(NCCN Guidelines®)优于基于聚合酶链反应的方法来检测EGFR外显子20插入变体。NCCN指南包括:
Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.8 †‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.8 †‡Amivantamab-vmjw (RYBREVANT®) plus carboplatin and pemetrexed as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC, or as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without immunotherapy and have EGFR exon 20 insertion mutation-positive advanced NSCLC.8 †‡Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.8 †‡In addition to MARIPOSA-2, RYBREVANT® is being studied in multiple clinical trials in NSCLC, including:.
Amivantamab vmjw(RYBREVANT®)加lazertinib(LAZCLUZE™)作为EGFR外显子19缺失或外显子21 L858R突变的局部晚期或转移性NSCLC患者一线治疗的1类推荐。8†‡Amivantamab vmjw(RYBREVANT®)加化疗作为局部晚期或转移性NSCLC EGFR外显子19缺失或外显子21 L858R突变患者的1类推荐,这些患者在接受osimertinib治疗后出现疾病进展。8†‡Amivantamab vmjw(RYBREVANT®)加卡铂和培美曲塞作为初治晚期或转移性EGFR外显子20插入突变阳性晚期非小细胞肺癌患者一线治疗的1类推荐药物,或作为铂类化疗后或铂类化疗后有进展的患者的2A类推荐药物,有或没有免疫治疗,EGFR外显子20插入突变阳性的晚期非小细胞肺癌。8†‡Amivantamab vmjw(RYBREVANT®)对于在铂类化疗或铂类化疗后有或无免疫治疗进展且EGFR外显子20插入突变阳性NSCLC的患者,作为2A类推荐。8†‡除MARIPOSA-2外,RYBREVANT®正在NSCLC的多项临床试验中进行研究,包括:。
The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT® in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations.12The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.13The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE™ with subcutaneous amivantamab compared to intravenous amivantamab in patients with EGFR-mutated advanced or metastatic NSCLC.10The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.14The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® in combination with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in patients with advanced NSCLC with EGFR mutations.15The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab subcutaneous delivery.16The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.17The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT® and capmatinib combination therapy in locally advanced or metastatic NSCLC.18The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT® and cetrelimab combination therapy in locally advanced or metastatic NSCLC.19The Phase 2 SKIPPirr study (NCT05663866) exploring how to decrease the incidence and/or severity of first-dose infusion-related react.
3期MARIPOSA(NCT04487080)研究评估了RYBREVANT®联合LAZCLUZE™与osimertinib以及单独使用LAZCLUZE™一线治疗EGFR ex19del或替代突变的局部晚期或转移性NSCLC患者。12 3期PAPILLON(NCT04538664)研究评估了RYBREVANT®联合卡铂-培美曲塞与单独使用化疗一线治疗EGFR外显子20插入突变的晚期或转移性NSCLC患者。13 3期PALOMA-3(NCT05388669)研究评估了皮下注射LAZCLUZE™10评估晚期非小细胞肺癌患者RYBREVANT®的1期蛹(NCT02609776)研究。14 1/1b期蛹-2(NCT04077463)研究评估RYBREVANT®联合LAZCLUZE™和LAZCLUZE™作为EGFR突变晚期非小细胞肺癌患者的单一疗法。15第一阶段PALOMA(NCT04606381)研究评估了基于安全性和药代动力学的皮下注射阿米万塔单抗的可行性,并确定了阿米万塔单抗皮下给药的剂量,剂量方案和配方。16第二阶段PALOMA-2(NCT05498428)研究评估了包括EGFR突变的NSCLC在内的晚期或转移性实体瘤患者的皮下注射阿米万塔单抗。17第1/2阶段METalmark(NCT05488314)研究评估了RYBREVANT®和capmatinib联合治疗局部晚期或转移性NSCLC.18 1/2期PolyDamas(NCT05908734)研究评估了RYBREVANT®和cetrelimab联合治疗局部晚期或转移性NSCLC.19 2期SKIPPirr研究(NCT05663866)探索如何降低首次剂量输注相关反应的发生率和/或严重程度。
Access to RYBREVANT®
访问RYBREVANT®
J&J offers comprehensive access and support information and resources to assist patients in gaining access to RYBREVANT®. Our patient support program, J&J withMe, is available to provide personalized support to help patients start and stay on their J&J medicines. J&J withMe offers providers help supporting their patients by verifying patients' insurance coverage, providing information on Prior Authorization and Appeals processes and educating on reimbursement processes.
强生公司提供全面的访问和支持信息和资源,以帮助患者获得RYBREVANT®。我们的患者支持计划J&J withMe可提供个性化支持,以帮助患者开始并继续服用强生药物。强生withMe通过核实患者的保险范围、提供有关事先授权和上诉程序的信息以及对报销程序的教育,为提供者提供帮助,帮助他们支持患者。
Patients can connect to RYBREVANT withMe to receive cost support, regardless of insurance type, free, personalized one-on-one support from a Care Navigator, and resources and community connections. Learn more at RYBREVANTwithMe.com or by calling 833-JNJ-wMe1 (833-565-9631).♠.
患者可以与我联系RYBREVANT以获得成本支持,无论保险类型如何,护理导航员提供的免费个性化一对一支持,以及资源和社区联系。请访问RYBREVANTwithMe.com或致电833-JNJ-wMe1(833-565-9631)了解更多信息。♠.
About Non-Small Cell Lung Cancer (NSCLC)
关于非小细胞肺癌(NSCLC)
Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.21,22 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.23 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.24 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.23,24,25,26,27,28 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.29 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.2,3 EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.30 Patients with EGFR exon 20 insertion mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.31.
在全球范围内,肺癌是最常见的癌症之一,NSCLC 占所有肺癌病例的 80% 至 85%。21,22 NSCLC 的主要亚型为腺癌、鳞状细胞癌和大细胞癌。表皮生长因子受体是一种控制细胞生长和分裂的受体酪氨酸激酶。24 表皮生长因子受体突变出现在10%至15%的西方腺癌组织学NSCLC患者中,出现在40%至50%的亚洲患者中。表皮生长因子受体ex19del或表皮生长因子受体L858R突变是最常见的表皮生长因子受体突变。29 所有接受表皮生长因子受体酪氨酸激酶抑制剂(TKIs)治疗的晚期NSCLC和表皮生长因子受体突变患者的五年生存率低于20%。在一线治疗中,表皮生长因子受体外显子 20 插入突变患者的实际 5 年 OS 为 8%,比表皮生长因子受体外显子 19del 或 L858R 突变患者更差,后者的实际 5 年 OS 为 19%。
About Johnson & Johnson
关于强生公司
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
在强生公司,我们相信健康就是一切。我们在医疗创新方面的优势使我们能够建立一个预防、治疗和治愈复杂疾病的世界,在这个世界上,治疗更加智能,侵入性更小,解决方案更加个性化。通过我们在创新医学和医学技术方面的专业知识,我们拥有独特的优势,可以在今天的所有医疗保健解决方案中进行创新,以实现明天的突破,并深刻影响人类的健康。