Carboplatin

临床试验病友交流群（点击） 对于没有EGFR、ALK等驱动基因突变的晚期肺癌患者，一线治疗往往只有化疗、免疫治疗或联合抗血管生成药物。但多种药物联用，不仅副作用叠加，经济负担也更重。 有没有一种药物，能把“免疫检查点抑制剂”和“抗血管生成靶向药”合二为一？BNT327（代号PM8002）做到了。这款国产双特异性抗体，已在此前的临床试验中交出了令人振奋的成绩单： EGFR突变耐药后患者：治疗应答率54.7%，疾病控制率95.3% PD-L1高表达（TPS≥50%）亚组：治疗应答率高达92.3% 如今，BNT327继续向一线治疗进军——针对初治的晚期非小细胞肺癌（IIIB-IV期、驱动基因阴性）患者，联合标准化疗，疗效值得期待。本文将为您解读BNT327的作用机制、已有数据，以及最新的II期临床试验招募要求。 一、BNT327是什么？疗效数据如何？ 一箭双雕：BNT327（也称PM8002）是一种靶向PD-L1和VEGF-A的双特异性抗体。 PD-L1：癌细胞用它来“伪装”自己，抑制免疫T细胞的攻击。BNT327阻断PD-L1，相当于揭下癌细胞的伪装，让免疫系统恢复杀伤能力。 VEGF-A：促进肿瘤新生血管生成，为癌细胞输送养分。BNT327同时抑制VEGF-A，能“饿死”肿瘤，还能改善肿瘤微环境，帮助免疫细胞更好地进入肿瘤内部。 将两个靶点集中在一个药物分子上，相比分别使用PD-1抑制剂+抗血管生成药（如贝伐珠单抗），不良反应更可控，患者用药更方便。 根据2024年ESMO大会上公布的研究数据（针对EGFR突变阳性、靶向药耐药后的晚期非小细胞肺癌患者）： 64名可评估患者中，54.7%的患者肿瘤病灶缩小超过30%（客观缓解率ORR）； 疾病控制率（DCR）高达95.3%，即绝大多数患者的病情得到稳定或缓解； PD-L1表达阴性（TPS<1%）的患者，ORR仍有35.7%，DCR 92.9%； PD-L1 TPS 1%~49%的患者，ORR为56.5%； PD-L1 TPS≥50%的高表达患者，ORR达到92.3%，几乎人人都有效。 安全性方面，≥3级不良反应发生率为54.7%，免疫相关不良事件发生率28.1%，总体可耐受。这些数据证明了BNT327联合化疗在后线治疗中的强大潜力。现在，这款药物的研究方向转向了更前线、更广泛的人群——未经系统治疗的驱动基因阴性晚期非小细胞肺癌患者。 二、BNT327联合化疗 II期临床试验招募 试验基本信息：试验登记号：CTR20252064 药物方案：BNT327（PM8002）+ 化疗（培美曲塞/紫杉醇 + 卡铂） 研究阶段：II期 目标人群：未经系统治疗的IIIB或IIIC期（不适合根治性手术或放疗）或IV期非小细胞肺癌 核心入选标准 年龄：≥18岁 诊断：经组织学或细胞学证实的IIIB期、IIIC期（不适合根治性手术或放疗）或IV期非小细胞肺癌 驱动基因：EGFR、ALK均为阴性（无敏感突变） PD-L1表达 不限（无论高低均可入组） 既往治疗：未经系统抗肿瘤治疗（不包括辅助/新辅助治疗结束≥6个月后复发） 体能状态：ECOG 0或1分 可测量病灶 根据RECIST v1.1至少有一个可测量病灶 排除标准 既往接受过免疫检查点抑制剂（如抗PD-1/PD-L1抗体）或抗VEGF/VEGFR靶向治疗； 有活动性脑转移或脑膜转移（经治稳定者可酌情考虑）； 有严重出血倾向或未控制的自身免疫性疾病； 对其他单抗或化疗药物严重过敏。 以上为简化版条件，最终能否入组由研究医生根据全面检查结果评估。 开展中心 目前全国多家三甲医院肿瘤中心正在招募，包括但不限于：北京、上海、广州、杭州、南京、武汉、成都、西安等城市。具体研究中心名单及联系方式，可通过下方渠道咨询。（在微信扫描下面图片的二维码添加癌度咨询） 欢迎微信扫描下面的二维码报名咨询！

Reports First-Quarter Diluted EPS of $0.39 on a GAAP Basis, a Decrease of 45.8 Percent; Adjusted Diluted EPS of $2.65, an Increase of 7.7 Percent; These Results Include an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense Delivers First-Quarter Net Revenues of $15.002 Billion, an Increase of 12.4 Percent on a Reported Basis or 10.3 Percent on an Operational Basis First-Quarter Global Net Revenues from the Immunology Portfolio Were $7.290 Billion, an Increase of 16.4 Percent on a Reported Basis, or 14.3 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.483 Billion; Global Rinvoq Net Revenues Were $2.119 Billion; Global Humira Net Revenues Were $688 Million First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.875 Billion, an Increase of 26.0 Percent on a Reported Basis, or 24.3 Percent on an Operational Basis; Global Vraylar Net Revenues Were $905 Million; Global Botox Therapeutic Net Revenues Were $1.009 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $635 Million; Global Vyalev Net Revenues Were $201 Million First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.631 Billion, a Decrease of 0.2 Percent on a Reported Basis, or 3.0 Percent on an Operational Basis; Global Venclexta Net Revenues Were $770 Million; Global Imbruvica Net Revenues Were $556 Million; Global Elahere Net Revenues Were $198 Million First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.186 Billion, an Increase of 7.6 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $668 Million; Global Juvederm Net Revenues Were $232 Million Raises 2026 Adjusted Diluted EPS Guidance Range from $13.96 - $14.16 to $14.08 - $14.28, which Includes an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2026 NORTH CHICAGO, Ill., April 29, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2026. "We are off to an excellent start in 2026, with first-quarter results exceeding our expectations. AbbVie's key growth drivers continue to deliver strong performance and support our enhanced full-year outlook," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We are also generating exciting data and advancing numerous programs across all stages of development. Our pipeline progress and solid business fundamentals position AbbVie for robust long-term growth." First-Quarter Results Worldwide net revenues were $15.002 billion, an increase of 12.4 percent on a reported basis, or 10.3 percent on an operational basis. Global net revenues from the immunology portfolio were $7.290 billion, an increase of 16.4 percent on a reported basis, or 14.3 percent on an operational basis. Global Skyrizi net revenues were $4.483 billion, an increase of 30.9 percent on a reported basis, or 29.2 percent on an operational basis. Global Rinvoq net revenues were $2.119 billion, an increase of 23.3 percent on a reported basis, or 20.2 percent on an operational basis. Global Humira net revenues were $688 million, a decrease of 38.6 percent on a reported basis, or 40.3 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.875 billion, an increase of 26.0 percent on a reported basis, or 24.3 percent on an operational basis. Global Vraylar net revenues were $905 million, an increase of 18.4 percent. Global Botox Therapeutic net revenues were $1.009 billion, an increase of 16.5 percent on a reported basis, or 14.9 percent on an operational basis. Global Ubrelvy net revenues were $339 million, an increase of 41.4 percent on a reported basis, or 41.2 percent on an operational basis. Global Qulipta net revenues were $296 million, an increase of 53.6 percent on a reported basis, or 51.3 percent on an operational basis. Global Vyalev net revenues were $201 million. Global net revenues from the oncology portfolio were $1.631 billion, a decrease of 0.2 percent on a reported basis, or 3.0 percent on an operational basis. Global Venclexta net revenues were $770 million, an increase of 15.7 percent on a reported basis, or 9.7 percent on an operational basis. Global Imbruvica net revenues were $556 million, a decrease of 24.7 percent. Global Elahere net revenues were $198 million, an increase of 10.7 percent on a reported basis, or 8.3 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.186 billion, an increase of 7.6 percent on a reported basis, or 5.1 percent on an operational basis. Global Botox Cosmetic net revenues were $668 million, an increase of 20.2 percent on a reported basis, or 17.0 percent on an operational basis. Global Juvederm net revenues were $232 million, an increase of 0.4 percent on a reported basis, or a decrease of 2.9 percent on an operational basis. On a GAAP basis, the gross margin ratio in the first quarter was 71.9 percent. The adjusted gross margin ratio was 83.6 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 23.9 percent of net revenues. The adjusted SG&A expense was 22.7 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 16.5 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues. Acquired IPR&D and milestones expense was 5.0 percent of net revenues. On a GAAP basis, the operating margin ratio in the first quarter was 26.6 percent. The adjusted operating margin ratio was 40.8 percent. Net interest expense was $645 million. On a GAAP basis, the tax rate in the quarter was 32.9 percent. The adjusted tax rate was 15.4 percent. Diluted earnings per share (EPS) in the first quarter was $0.39 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie announced it submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Skyrizi (risankizumab) for subcutaneous (SC) induction in the treatment of adult patients with moderately to severely active Crohn's disease (CD). AbbVie expects an approval decision later this year, which would offer adult CD patients an additional option for induction of Skyrizi. The submission is supported by data from the Phase 3 AFFIRM study evaluating the efficacy and safety of Skyrizi SC induction in adult patients with moderately to severely active CD. In the study, Skyrizi achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by SC injection versus placebo. The safety profile of Skyrizi SC induction was consistent with its known profile in CD, with no new safety risks observed. AbbVie announced it submitted an application to the FDA for a new indication for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients with severe alopecia areata (AA). The submission is supported by data from the Phase 3 UP-AA clinical program in which Rinvoq achieved the primary endpoint as well as key secondary endpoints. At the 2026 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented key data reinforcing the company's leadership in advancing standards of care across immune-mediated skin diseases. Presentations showcased the efficacy and safety of Skyrizi in psoriatic disease, real-world evidence of minimal disease activity and clinical long-term safety outcomes of Rinvoq in atopic dermatitis (AD), as well as Phase 3 data for Rinvoq in vitiligo and AA. The company also presented data highlighting the safety and efficacy of new and emerging products in AbbVie's aesthetics portfolio, including trenibotulinumtoxinE. AbbVie announced the FDA approved a supplemental new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). This approval establishes the Venclexta and acalabrutinib combination as the first all-oral, fixed-duration regimen for previously untreated CLL, offering patients the potential of time off treatment. The approval is supported by data from the Phase 3 AMPLIFY trial. At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie presented Phase 2 data for Elahere in platinum-sensitive ovarian cancer (PSOC). Results from the IMGN853-0420 trial showed a more than 60 percent objective response rate (ORR) and consistent safety findings with Elahere plus carboplatin followed by a continuation of Elahere monotherapy in patients with folate receptor alpha (FRα)-expressing PSOC. These findings highlight Elahere's potential expanding role across the ovarian cancer treatment continuum. AbbVie announced it received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (trenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for trenibotE and does not request additional clinical studies. AbbVie is confident that it can address the FDA's comments promptly and expects to submit a thorough response in the coming months. AbbVie announced positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. In the study, ABBV-295 treatment showed clinically meaningful body weight reduction at week 12 (weekly dosing) and week 13 (every other week and monthly dosing after week 5). ABBV-295 also demonstrated a favorable tolerability profile at all evaluated dose levels, with no serious adverse events reported. Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action. AbbVie announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines. AbbVie announced a $380 million investment to build two new active pharmaceutical ingredient (API) manufacturing facilities at its North Chicago, Illinois, campus. These state-of-the-art facilities will integrate advanced manufacturing technologies with AI to support the production of AbbVie's next-generation neuroscience and obesity medications. AbbVie announced the opening of the Allergan Medical Institute (AMI) Training Center in Austin, Texas. This location marks the third U.S. AMI Training Center opened in the last year, reflecting AbbVie's continued investment in aesthetics training and education. Full-Year 2026 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2026 from $13.96 - $14.16 to $14.08 - $14.28, which includes an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2026. The company's 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2026, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie 21% more press release views with Request a Demo