Pemetrexed Dipotassium

16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patientsConfirmed overall response rate (cORR) 68.2% and duration of response (DOR) 14.6 months by BICR in first-line patientsConfirmed CNS (central nervous system) responses with firmonertinib including complete responses (CRs) by BICRFirmonertinib rapidly decreased or cleared PACC circulating tumor DNA (ctDNA) in frontline patients across PACC mutation types (frequent, less frequent and compound PACC) consistent with broad PACC activityEnrollment of the first patient in the global pivotal Phase 3 ALPACCA study in first-line EGFR PACC mutant non-small cell lung (NSCLC) cancer expected in the second half of 2025 NEWTOWN SQUARE, Pa., Sept. 09, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the IASCLC 2025 annual World Conference on Lung Cancer (WCLC), in Barcelona, Spain. “Our 16-month prolonged progression free survival with once daily oral firmonertinib monotherapy has been maintained with 16.5 months of median follow up and we are particularly encouraged by the CNS responses including CNS complete responses” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Together this data reinforces the potential of firmonertinib to address key unmet needs in the global EGFR mutant NSCLC treatment landscape. Additionally, the rapid clearance of PACC ctDNA in frontline patients observed across a broad range of PACC mutations, including those with frequent, less frequent and compound PACC mutations, is consistent with the broad activity of firmonertinib in PACC mutant NSCLC. We expect to enroll the first patient in our global registrational ALPACCA Phase 3 trial in frontline PACC patients in the second half of the year.” Key Highlights of Longer-term Final Analysis Data for Firmonertinib Monotherapy: Maintained Clinically Meaningful PFS and Durable Responses 16.0 months mPFS with firmonertinib once daily 240 mg by BICR, with majority of patients remaining on study14.6 months median duration of response with firmonertinib 240 mg by BICR68.2% and 43.5% confirmed ORR by BICR at 240 mg and 160 mg, respectively Confirmed responses at first tumor assessment in the majority of patientsResponses across a wide range of EGFR PACC mutations including most frequent (G719X, S768I), less frequent (E709X, V774M) and compound mutations 42.9% (6/14) CNS confirmed ORR and 35.7% (5/14) CNS confirmed CRs in CNS evaluable disease front-line patients by BICR Safety Profile Continues to be Consistent with No New Safety Signals Generally well-tolerated and manageable safety profile maintained over longer treatment durationMost frequent treatment-related adverse events include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skinNo new safety findings with further follow up and safety profile remains consistent with EGFR-TKI class Rapidly Decreased or Cleared PACC ctDNA in Frontline Patients 82% (9/11) and 79% (11/14) ctDNA clearance in frontline PACC patients treated with firmonertinib at 240 mg and 160 mg, respectively, in patients with detectable PACC ctDNA at baselineConsistent decreases in ctDNA across different PACC mutations were observed including in patients with frequent, less frequent and compound mutations About ArriVentArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. About Firmonertinib Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd. About EGFR mutant NSCLC Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need. About EGFR PACC mutations P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients. About FURVENT FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. Topline data expected in early 2026. An interim analysis for this study has not been performed and there is no plan to perform such analysis. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, cash runway, estimates of our addressable market, activity of firmonertinib compared to available therapies, duration of firmonertinib therapy in NSCLC patient populations, anticipated clinical milestones, the timing of, and results of, top-line pivotal Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, the timing of potential enrollment of the first patient in the global pivotal Phase 3 ALPACCA study of firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR PACC mutations, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 3, 2025 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

FLAURA2 最终总生存期分析进一步证实了该联合方案有利的获益 - 风险特征 以上结果巩固了奥希替尼无论分期，都是 EGFR 突变阳性非小细胞肺癌基石疗法的地位 上海 2025年9月8日 /美通社/ -- FLAURA2 III期临床研究最终总生存期（OS）分析的阳性结果显示，阿斯利康泰瑞沙 ® （英文商品名：TAGRISSO ® ，通用名：甲磺酸奥希替尼片，以下简称"奥希替尼"）联合培美曲塞和铂类化疗药物用于具有表皮生长因子受体（EGFR）外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗中，与奥希替尼单药相比，在关键次要研究终点OS上显示出具有统计学意义以及临床意义显著的改善。 该结果已于9月7日在西班牙巴塞罗那举行的国际肺癌研究协会（IASLC）2025年世界肺癌大会（WCLC）全体大会上公布（摘要编号#PL02.06）。 最终OS分析结果显示，奥希替尼联合化疗组的中位OS接近四年（47.5个月），奥希替尼单药治疗组约为三年（37.6个月）。在57%数据成熟度下，结果显示奥希替尼联合化疗与奥希替尼单药治疗相比，死亡风险降低了23%（基于风险比[HR]为0.77；95%置信区间[CI]为0.61-0.96；p=0.0202）。据估计，联合治疗组中有63.1%的患者在三年时存活，49.1%的患者在四年时存活，而单药治疗组分别为50.9%和40.8%。值得注意的是，奥希替尼联合化疗相较于奥希替尼单药治疗的OS获益在所有预设亚组中均保持一致。对照组患者在疾病进展后接受了包括化疗在内的标准治疗（交叉治疗率72%），进一步支持了OS结果的临床意义。 法国古斯塔夫鲁西研究所肿瘤研究所，胸部肿瘤组主任、FLAURA2试验首席研究员，医学博士David Planchard表示："肺癌治疗的根本目标是延长患者的生存时间，同时保障患者的生活质量。这项令人信服的研究结果展示了前所未有的中位总生存期，表明该联合方案能够同时实现这两个目标，并支持奥希替尼，无论是否联合化疗，作为晚期一线EGFR敏感突变阳性非小细胞肺癌患者的标准治疗方案。对于这些患者，现在有两种基于奥希替尼的高效治疗方案，医生可以更好地根据病人的个体需求定制治疗方案，从而确保每位患者获得最佳的治疗效果。" 阿斯利康全球执行副总裁、肿瘤研发负责人高书璨博士（Dr. Susan Galbraith）表示："FLAURA2的最新研究结果表明，奥希替尼联合化疗方案在晚期EGFR敏感突变阳性非小细胞肺癌一线治疗中展现出接近四年的中位总生存期，超越了FLAURA临床研究在此前设立的三年基准线，为肺癌患者带来了新的生存希望。过去十年来，奥希替尼在非小细胞肺癌所有分期的治疗中，持续带来的显著生存获益和可耐受的安全性，巩固了奥希替尼作为EGFR敏感突变阳性非小细胞肺癌基石疗法的地位。" OS 结果总结： FLAURA2 奥希替尼联合化疗 (n=279) 奥希替尼单药 (n=278) 中位OS i, ii, iii ，单位：月 47.5 (41.0-NC iv ) 37.6 (33.2 ,43.2) 风险比(95% CI) 0.77 (0.61-0.96) 分层log-rank检验P值 v 0.0202 死亡病例数n（%） 144 (51.6) 171 (61.5) 数据成熟度 57 % 24个月OS率（%） 79.7 (74.5-84.0) 71.5 (65.8-76.5) 36个月OS率（%） 63.1 (57.1-68.5) 50.9 (44.8-56.6) 48个月OS率（%） 49.1 (43.0-55.0) 40.8 (34.9-46.6) i.       OS数据截止日期为 2025 年6 月 12日 ii.      在数据截止时，接受奥希替尼联合化疗治疗的患者中位随访时间为51.2个月（范围0.2-60.4个月），而 接受奥希替尼单药治疗的患者中位随访时间为51.3个月（范围0.1-60.1个月） iii.      使用Kaplan–Meier法计算 iv.      无法计算 v.       根据O'Brien和Fleming的消耗规则，统计显著性要求双侧p值小于0.04953。 随着随访时间延长，奥希替尼联合化疗的安全性仍可管理，且与各单独药物已知的安全性一致。在所有原因导致的3级或更高级别不良事件（AEs）中，奥希替尼联合化疗组的发生率为70%，主要由特征明确的化疗相关AEs驱动，而奥希替尼单药组为34%，与2023年IASLC WCLC大会上首次公布的主要分析结果（64% vs 27%）相似‌。两组因AEs导致的靶向药物停药率均较低（12% vs 7%）‌。 关于非小细胞肺癌（ NSCLC ） 肺癌是癌症死亡的主要原因，约占所有癌症死亡病人数的五分之一 ‌1 。肺癌通常分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中非小细胞肺癌约占所有肺癌患者的80-85% 2‌ 。大部分（约75%）非小细胞肺癌患者在确诊时已是晚期。 3 美国和欧洲的非小细胞肺癌患者中约有10-25％存在EGFR突变，而亚洲患者中该比例则高达30-40% 4-6 。 尽管EGFR酪氨酸激酶抑制剂（TKI）显著改善了一线治疗的疗效，但耐药机制和疾病进展极为常见，在后续治疗方案中对有效且耐受性良好的治疗选择上仍存在着重大的未满足需求 7-10 。 关于 FLAURA2 研究 FLAURA2是一项随机对照、开放标签、全球多中心的III期试验，对局部晚期(IIIB-IIIC期)或转移性(IV期)EGFR突变（19del/21L858R）的非小细胞肺癌患者进行一线治疗。试验组患者接受奥希替尼80mg每日一次口服片剂联合化疗（培美曲塞（500mg/m2）加顺铂（75mg/m2）或卡铂（AUC5）），每三周一次，持续四个周期，随后每三周接受一次泰瑞沙联合培美曲塞维持治疗，对照组患者接受奥希替尼80mg每日一次口服。 该研究共入组557例患者，在全球包括美国、欧洲、南美和亚洲在内的150多个研究中心开展。主要终点为无进展生存期（PFS），总生存期（OS）为关键次要终点。 关于奥希替尼 奥希替尼是一种不可逆的第三代EGFR-TKI，在治疗非小细胞肺癌（包括伴中枢神经系统转移）患者中有确证的临床活性。奥希替尼（40mg和80mg每日一次口服片剂）在全球获批的各种适应症已治疗了超过100万名患者。阿斯利康正继续探索奥希替尼用于治疗不同疾病分期的EGFR突变非小细胞肺癌患者。 奥希替尼已在包括美国、欧盟、中国和日本在内的120多个国家获批作为单药疗法使用。获批适应症包括：一线治疗局部晚期或转移性EGFR突变（19del/21L858R）阳性非小细胞肺癌患者；局部晚期或转移性既往EGFR-TKI治疗失败伴EGFR T790M突变阳性NSCLC患者的治疗；早期EGFRm（19del/21L858R）NSCLC患者的辅助治疗；以及局部晚期、不可切除EGFRm（19del/21L858R） NSCLC患者在接受含铂化疗放疗（CRT）后的治疗。泰瑞沙联合化疗方案已在包括美国、欧盟、中国和日本在内的80多个国家获批，用于一线治疗局部晚期或转移性EGFRm NSCLC患者‌。 有大量证据支持奥希替尼作为 EGFR突变非小细胞肺癌的推荐治疗，它是目前唯一*一个证实可改善各个分期非小细胞肺癌患者临床结局的靶向疗法。 在晚期患者中，奥希替尼在FLAURA III期研究中作为单药疗法，以及在FLAURA2 III期研究中联合化疗，均显示出临床结局改善。在晚期患者中，奥希替尼与赛沃替尼联合疗法的SAFFRON III期研究，以及与DATROWAY®（达托泊单抗或Dato-DXd）联合疗法的TROPION-Lung14和TROPION-Lung15 III期研究正在进行中。 奥希替尼在针对早期患者的NeoADAURA和ADAURA III期研究以及针对局部晚期患者的LAURA III期研究中，均改善了患者的临床结局。作为阿斯利康持续承诺治疗早期肺癌的重要组成部分，ADAURA2 III期研究正在进行中，评估奥希替尼用于早期可切除辅助治疗。 关于阿斯利康在肺癌领域的研究 阿斯利康正致力于通过早诊早治提高肺癌患者的治愈率，同时推动相关技术不断向前发展，以改善耐药患者和晚期患者的治疗结局。通过定义新的治疗靶点和评价创新疗法，阿斯利康致力于实现将最合适的药物用于能最大化获益的患者。 公司丰富的产品组合包括领先的肺癌药物以及下一阶段的创新药物，包括奥希替尼和吉非替尼；度伐利尤单抗和tremelimumab；与第一三共合作开发的德曲妥珠单抗和德达博妥单抗；与和黄医药合作开发的赛沃替尼；以及横跨各种作用机制的新药及其组合的产品管线。 阿斯利康是全球Lung Ambition Alliance的创始成员，该全球性联盟致力于加快创新步伐，并为肺癌患者提供包括治疗和治疗以外的具有意义的改善措施。 关于阿斯利康在肿瘤领域的研究 阿斯利康正引领着肿瘤领域的一场革命，致力提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。 阿斯利康的肿瘤业务专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已经建立了领先全行业的多元化产品组合和渠道，持续推动医疗实践变革，改变患者体验。 阿斯利康的愿景旨在重新定义癌症治疗，以期未来终结癌症这一致死之因。 关于阿斯利康 阿斯利康(LSE/STO/Nasdaq: AZN)是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问 www.astrazeneca.com 。 关于阿斯利康中国 阿斯利康自1993年进入中国以来，专注中国患者需求最迫切的治疗领域，包括肿瘤、心血管、肾脏、代谢、呼吸、消化、罕见病、疫苗抗体及自体免疫等，已将40多款创新药物带到中国。阿斯利康中国总部位于上海，并在上海和北京设立全球战略研发中心，在北京、广州、杭州、成都、青岛设立区域总部，在无锡、泰州、青岛建立全球生产供应基地，向全球70多个市场输送优质创新药品。 * 截至 2025.09.08 ，用 EGFR-TKI 和 OS 作为关键词在 PubMed 和 MEDLINE 数据库中检索全部时间范围内的 RCT 研究 声明：本文涉及未在中国获批的产品或者适应症，阿斯利康不推荐任何未被批准的药物使用。 参考文献 1.     World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025. 2.     American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 3.     Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine . 2021;100(6):e24688. 4.     Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol . 2011:29;2121-27. 5.     Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol . 2013;6:2800-2812. 6.     Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol . 2013;66:79-89. 7.     Chen R, et al. Emerging therapeutic agents for advanced non-small cell lung cancer. J Hematol Oncol . 2020;13(1):58. 8.     Majeed U, et al. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends. J Hematol Oncol . 2021;14(1):108. 9.     Morgillo F, et al. Mechanisms of resistance to EGFR-targeted drugs: lung cancer. ESMO Open . 2016;1(3):e000060. 10.  Han B, et al. Efficacy of pemetrexed-based regimens in advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations after tyrosine kinase inhibitor failure: a systematic review. Onco Targets Ther . 2018;11:2121-2129.