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更新于：2025-09-05
ABBV-706
更新于：2025-09-05
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项与 ABBV-706 相关的临床试验NCT07155174
A Phase 2/3 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 730 adult participants will be enrolled in the study across sites worldwide.
In the phase 2 (safety lead-in) , participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the phase 2 (expansion) portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. In the phase 3 (registrational) portion of the study, participants with SCLC will receive IV ABBV-706 in at the optimized dose with atezolizumab, or IV SOC. The estimated duration of the study is up to 69.5 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 730 adult participants will be enrolled in the study across sites worldwide.
In the phase 2 (safety lead-in) , participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the phase 2 (expansion) portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. In the phase 3 (registrational) portion of the study, participants with SCLC will receive IV ABBV-706 in at the optimized dose with atezolizumab, or IV SOC. The estimated duration of the study is up to 69.5 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
开始日期2025-12-06 |
申办/合作机构 |
CTR20244840
一项在晚期实体瘤成人受试者中评估ABBV-706单药治疗以及与Budigalimab（ABBV-181）、卡铂或顺铂联合治疗的安全性、药代动力学和疗效的I期首次人体研究。
本研究的目的是评价ABBV-706单药治疗以及与Budigalimab、卡铂或顺铂联合治疗的安全性、耐受性、药代动力学和初步疗效。
开始日期2025-02-19 |
申办/合作机构 |
CTIS2023-504598-18-00
- M23-385
开始日期2024-04-26 |
100 项与 ABBV-706 相关的临床结果
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100 项与 ABBV-706 相关的转化医学
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100 项与 ABBV-706 相关的专利（医药）
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27
项与 ABBV-706 相关的新闻（医药）2025-08-15
·抗体密码
WCLC即将在2025年9月6日至9举行，近日相关会议摘要已经发布，在今年的会议上，多款创新型疗法亮相SCLC的治疗，其中BioNtech的PD-L1/VEGF双抗BNT327和Amgen的DLL3/CD3双抗Tarlatamab分别与化疗和PD-L1联合用于一线ES-SCLC的治疗，恒瑞的DLL3-ADC SHR-4849 (IDE849)，齐鲁医药的B7-H3-ADC QLC5508，默沙东/第一三共B7-H3 ADC ifinatamab deruxtecan，艾伯维的SEZ6-ADC ABBV-706,君实生物抗BTLA抗体Tifcemalimab单药或联合抗PD-1抗体Toripalimab。
1）首先是Amgen的DLL3/CD3双抗Tarlatamab联合PD-L1作为ES-SCLC患者在化学-免疫治疗后的一线维持治疗。在最后一个化疗-免疫治疗周期开始后的8周内，患者接受Tarlatamab（10mg IV Q2W）联合阿替利珠单抗（1680mg IV Q4W）或度伐利尤单抗（1500mg IV Q4W）治疗，直至疾病进展。
在去年的相关会议上，Amgen已经公布了该疗法的初步疗效，截至2024年5月31日，共88例患者接受治疗，其中男性患者占62.5%，中位年龄为64.0岁。从开始一线化疗-免疫治疗到开始一线维持治疗的中位时间为3.6个月。患者在一线维持治疗开始后的中位PFS为5.6个月。由于随访时间不足，中位OS尚未成熟，9个月OS率估计值为88.9%。DCR为62.5%，中位DoR为9.3个月。
安全性分析中，中位随访10.0个月，未出现DLT。最常见的所有级别TEAE为CRS（53.4%）、消化不良（47.7%）和疲劳（34.1%）。最常见的≥3级TEAE为低钠血症（10.2%）、中性粒细胞减少（6.8%）和贫血（6.8%）。CRS主要发生在第一周期，多为1-2级，1例患者发生了3级CRS。分别有11.4%、2.3%、0%的患者发生了任意级别、3级、4级免疫效应细胞相关神经毒性综合征和相关神经事件。
2）接下来是BioNtech的PD-L1/VEGF双抗BNT327联合化疗在未经治疗的广泛期小细胞肺癌 （“ES-SCLC”） 患者以及一线或二线治疗后进展的 SCLC 患者中的疗效。
截至截止日期（2025年4月4日），已完成107例患者入组。在第一队列（N=43，中位年龄65.0岁[范围45-80]，62.8%患者ECOG PS评分为1；中位普米坦尼治疗持续时间11.6周）中，22例患者接受20 mg/kg普米坦尼治疗，21例接受30 mg/kg治疗。在38例可评估疗效的患者中，33例达到部分缓解（PR），5例疾病稳定（SD），未确认客观缓解率（uORR）达86.8%，疾病控制率（DCR）为100%。肿瘤大小最佳百分比变化的平均值为-47.3%，89.5%患者实现早期肿瘤缩小。20 mg/kg和30 mg/kg剂量组的uORR分别为95.0%和77.8%。在11例完成两次基线后肿瘤评估且随访>90天的患者中，两个剂量组的确认客观缓解率（cORR）均为81.8%（9/11），其中20 mg/kg组达100%（6/6），30 mg/kg组为60.0%（3/5）；缓解持续时间（DoR）和无进展生存期（PFS）数据尚未成熟。包括早期DoR和PFS在内的更新疗效数据将在后续公布。
基线循环肿瘤DNA（ctDNA）检出率为93.8%（32例cfDNA数据患者中30例阳性），中位肿瘤分数（TFx）为57.0%。在第三周期第一天（C3D1），所有可评估患者（n=18）均显示ctDNA较基线降低，中位TFx变化为-99.3%，ctDNA清除率达44.4%（8/18）。不同剂量组结果相似。
43例患者中35例（81.4%）报告了任何级别的治疗相关不良事件（AEs），其中23例（53.5%）为≥3级。普米坦尼相关≥3级AEs在20 mg/kg组报告1例，30 mg/kg组报告5例（高血压[2例]、血小板计数降低、咯血、蛋白尿和肺栓塞[各1例]）。6例（14.0%）患者因AEs停用普米坦尼（20 mg/kg组2例，30 mg/kg组4例）。未发生治疗相关死亡事件。
3）SHR-4849是恒瑞自主研发且具有知识产权的DLL3 ADC，其有效载荷是拓扑异构酶抑制剂（TOPOi），去年12月，恒瑞以超10亿美元的总额授权给美国IDEAYA Biosciences公司，恒瑞医药主导的中国I期临床试验（NCT06443489）已在小细胞肺癌（SCLC）治疗中显示出显著的抗肿瘤活性。截至2024年12月，该研究已入组70余例复发/难治性SCLC患者，其中11例可评估受试者的部分缓解率（按RECIST 1.1标准）达到约73%。安全性表现良好，大多数治疗相关不良事件（TRAEs）为1-2级（如血液学毒性、恶心）。值得关注的是，试验尚未达到最大耐受剂量（MTD），目前仍在进行剂量递增探索。
4）QLC5508 是一种新型的 B7-H3 ADC。今年 5 月，齐鲁制药以 13.45 亿元的价格从明慧医药引进了该产品大中华区权益，今年SCLC齐鲁报告了 ES-SCLC 患者生存和安全性的最新结果。
本次临床数据来源于剂量扩展阶段。剂量扩展阶段招募铂类化疗 ± PD-1/PD-L1 治疗失败的 ES-SCLC 患者，且既往治疗不超过三线或无法耐受标准治疗。剂量扩展阶段选择 1.6 mg/kg Q2W、2.0 mg/kg Q2W 和 2.4 mg/kg Q3W 剂量水平。
截至 2025 年 6 月 13 日，共入组 106 例患者，剂量水平分别为 1.6 mg/kg Q2W（n=30）、2.0 mg/kg Q2W（n=46）和 2.4 mg/kg Q3W（n=30）。大多数患者（90.6%）为 IV 期。曾接受过二线、三线和三线以上治疗的患者分别为 28 例（26.4%）、15 例（14.2%）和 7 例（6.6%）。超过一半的患者（58.5%）接受过免疫治疗。11 例（10.4%）患者曾接受过伊立替康治疗。
疗效方面，1.6 mg/kg Q2W、2.0 mg/kg Q2W 和 2.4 mg/kg Q3W 组的中位无进展生存期分别为 5.55 个月、5.95 个月和 5.52 个月。三个队列的总生存期分别为 11.50 个月、11.73 个月和 11.50 个月。
安全性方面，在 1.6 mg/kg Q2W、2.0 mg/kg Q2W 和 2.4 mg/kg Q3W 组中，分别有 15 例（50.0%）、16 例（34.8%）和 13 例（43.3%）患者发生了 ≥3 级治疗相关不良事件 (TRAE)。最常见的 ≥3 级 TRAE 为中性粒细胞计数减少（17.0%）和白细胞计数减少（10.4%）。两例（4.3%）患者因间质性肺疾病停止治疗，均来自 2.0 mg/kg Q2W 组。1 例患者（3.3%）在 1.6 mg/kg 组因治疗相关恶病质死亡
5）Ifinatamab deruxtecan（DS-7300a，简称：I-DXd）是第一三共利用其专有的DXd ADC技术设计，由人源化抗B7-H3 IgG1单克隆抗体通过可裂解四肽连接子与拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。
2024年9月7日，默沙东公布了Ifinatamab deruxtecan（I-DXd）治疗广泛期小细胞肺癌（ES-SCLC）患者的II期IDeate-Lung01试验的中期积极结果。
研究结果显示，在接受Ifinatamab deruxtecan治疗的ES-SCLC患者中，12mg/kg (n=42)和8mg/kg (n=46)剂量组的客观缓解率（ORR）分别为54.8%和26.1%；中位缓解持续时间（DOR）分别为4.2个月和7.9个月；疾病控制率（DCR）分别为90.5%和80.4%；中位无进展生存期（PFS）分别为5.5个月和4.2个月；中位总生存期（OS）分别为11.8个月和9.4个月。值得一提的是，12mg/kg被选为IDeate-Lung01 2期试验扩展部分和最近启动的IDeate-Lung02 3期研究的最佳剂量。
在基线时有脑靶病变的患者亚群中，通过中枢神经系统(CNS) BICR评估，在12mg/kg（n=10）和8mg/kg（n=6）队列中，颅内ORR分别为50.0%和66.7%。
6）ABBV-706治疗复发/难治性（R/R）小细胞肺癌（SCLC）患者的I期研究结果
研究设计：年龄≥18岁的R/R SCLC患者随机接受1.8 mg/kg或2.5 mg/kg剂量的ABBV-706（每3周一次静脉给药），直至疾病进展或出现不可耐受毒性。SEZ6表达水平为回顾性评估。允许既往接受治疗或未治疗的稳定脑转移患者入组，但排除曾接受SEZ6靶向抗体偶联药物（ADC）或含拓扑异构酶I抑制剂（Top1i）载荷ADC治疗的患者。主要研究目标包括评估疗效、安全性、药代动力学，并确定SCLC适应症的II期推荐剂量（RP2D）。
研究结果：共入组80例SCLC患者（1.8 mg/kg组41例，2.5 mg/kg组39例）。中位既往治疗线数为2线（范围：1-6），中位治疗持续时间为5.8个月（范围：0.7-11.3）。两组患者的SEZ6表达水平和基线特征均衡。
两剂量组客观缓解率（ORR）相近，但1.8 mg/kg组缓解持续时间（DOR）和无进展生存期（PFS）更长（详见附表）。在未接受过Top1i治疗和/或二线使用ABBV-706的患者中，ORR更高（1.8 mg/kg组分别为62.1%和81.3%）
安全性数据：1.8 mg/kg组安全性更优，全级别治疗相关不良事件（TRAEs）：1.8 mg/kg组85%、2.5 mg/kg组95%患者发生，最常见为贫血（51% vs 74%）和乏力（34% vs 39%）。≥3级TRAEs：1.8 mg/kg组49%、2.5 mg/kg组77%患者发生，以贫血（39% vs 62%）和中性粒细胞计数降低（17% vs 31%）为主。严重TRAEs：1.8 mg/kg组17%、2.5 mg/kg组10%。总体TRAEs影响：导致停药、给药中断、剂量降低和死亡的比率分别为9%、44%、28%和4%。间质性肺病发生率：9%。
7）君实生物tifcemalimab联合特瑞普利单抗和化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的Ib/II期研究。
该研究是一项多队列、开放标签、多中心的Ib/II期临床研究（NCT05664971），旨在晚期肺癌患者中评估tifcemalimab联合特瑞普利单抗和化疗治疗的安全性和疗效。研究共分为5个队列，其中队列5纳入既往未接受过系统性抗肿瘤治疗的ES-SCLC患者，接受tifcemalimab（200 mg，IV，Q3W）联合特瑞普利单抗（240 mg，IV，Q3W）和化疗（依托泊苷100 mg/m²+卡铂AUC 5或顺铂75 mg/m²，Q3W）治疗4周期，之后继续接受tifcemalimab联合特瑞普利单抗维持治疗，直至疾病进展、出现不可耐受毒性或完成2年tifcemalimab联合特瑞普利单抗治疗。主要终点包括安全性和研究者根据RECIST v1.1标准评估的客观缓解率（ORR），次要终点包括疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）等。
2023年7月12日至12月6日，共入组44例患者，中位年龄为63岁，男性占比84.1%（37/44）。中位随访时间为15.28个月。43例疗效可评估患者中，观察到37例部分缓解（PR）和6例疾病稳定（SD），ORR和DCR分别为86%和100%。中位PFS为5.7个月（95%CI: 4.8-7.0）。中位OS尚未达到，15个月OS率为63.5%。
安全性可管理，40例（90.9%）患者发生≥3级治疗期间出现的不良事件（TEAEs），最常见（≥20%）的≥3级TEAEs包括中性粒细胞计数下降（65.9%）、白细胞计数下降（25.0%）和血小板计数下降（25.0%）。20例（45.5%）患者发生了免疫相关不良事件（irAEs），其中≥3级irAEs发生率为15.9%。无治疗相关死亡事件发生。
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参考文献
WCLC abstract和相关公司披露
2025-07-31
Corporate News
Reports Second-Quarter Diluted EPS of $0.52 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.97, an Increase of 12.1 Percent; These Results Include an Unfavorable Impact of $0.42 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $15.423 Billion, an Increase of 6.6 Percent on a Reported Basis or 6.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.631 Billion, an Increase of 9.5 Percent on a Reported Basis, or 9.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.423 Billion; Global Rinvoq Net Revenues Were $2.028 Billion; Global Humira Net Revenues Were $1.180 Billion Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.683 Billion, an Increase of 24.2 Percent on a Reported Basis, or 24.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $900 Million; Global Botox Therapeutic Net Revenues Were $928 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $605 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.676 Billion, an Increase of 2.6 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $754 Million; Global Venclexta Net Revenues Were $691 Million; Global Elahere Net Revenues Were $159 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.279 Billion, a Decrease of 8.1 Percent on a Reported Basis, or 8.0 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $692 Million; Global Juvederm Net Revenues Were $260 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.67 - $11.87 to $11.88 - $12.08, which Includes an Unfavorable Impact of $0.55 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2025
NORTH CHICAGO, Ill., July 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2025.
"AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We're entering the second half of the year with substantial momentum and are once again raising our full-year outlook."
Second-Quarter Results
Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis. Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis. Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis. Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis. Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis. Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis. Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent. On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues. Acquired IPR&D and milestones expense was 5.3 percent of net revenues. On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent. Net interest expense was $678 million. On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent. Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense.
Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis.
Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis.
Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis.
Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
Recent Events
AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology. AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq's safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study. AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting. AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options. AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie's robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication. AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM). AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis. AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie's expertise in biotherapeutic drug development and commercialization with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology.
Full-Year 2025 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 - $11.87 to $11.88 - $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn.
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-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 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with 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 our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and 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 2024 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.
Media:
Investors:
Gabby Tarbert
Liz Shea
(224) 244-0111
(847) 935-2211
Todd Bosse
(847) 936-1182
Jeffrey Byrne
(847) 938-2923
AbbVie Inc.
Key Product Revenues
Quarter Ended June 30, 2025
(Unaudited)
% Change vs. 2Q24
Net Revenues (in millions)
Reported
Operationala
U.S.
Int'l.
Total
U.S.
Int'l.
Total
Int'l.
Total
NET REVENUES
$11,762
$3,661
$15,423
5.9 %
9.1 %
6.6 %
8.4 %
6.5 %
Immunology
6,097
1,534
7,631
6.7
22.3
9.5
20.7
9.2
Skyrizi
3,843
580
4,423
64.3
49.7
62.2
47.2
61.8
Rinvoq
1,452
576
2,028
42.7
39.6
41.8
37.5
41.2
Humira
802
378
1,180
(66.0)
(16.8)
(58.1)
(17.2)
(58.2)
Neuroscience
2,333
350
2,683
23.2
30.6
24.2
28.7
24.0
Vraylar
898
2
900
16.2
72.8
16.3
76.8
16.3
Botox Therapeutic
775
153
928
15.9
5.7
14.1
6.0
14.2
Ubrelvy
330
8
338
46.5
73.9
47.1
76.7
47.2
Qulipta
237
30
267
62.8
>100.0
77.5
>100.0
76.9
Vyalev
22
76
98
n/m
>100.0
>100.0
>100.0
>100.0
Duodopa
20
77
97
(13.6)
(13.7)
(13.7)
(16.3)
(15.7)
Other Neuroscience
51
4
55
(11.4)
(23.3)
(12.3)
(21.3)
(12.2)
Oncology
1,026
650
1,676
(1.0)
8.7
2.6
8.3
2.4
Imbruvicab
543
211
754
(8.9)
(11.2)
(9.5)
(11.2)
(9.5)
Venclexta
321
370
691
7.4
9.5
8.5
9.1
8.3
Elahere
138
21
159
8.0
n/m
24.2
n/m
23.7
Epkinlyc
22
48
70
57.4
>100.0
93.9
>100.0
92.3
Other Oncology
2
—
2
n/m
n/m
n/m
n/m
n/m
Aesthetics
797
482
1,279
(7.8)
(8.5)
(8.1)
(8.3)
(8.0)
Botox Cosmetic
410
282
692
(8.7)
0.9
(5.0)
1.2
(4.9)
Juvederm Collection
105
155
260
(23.6)
(24.4)
(24.0)
(24.4)
(24.0)
Other Aesthetics
282
45
327
1.6
5.8
2.2
6.4
2.3
Eye Care
226
288
514
(5.7)
(2.4)
(3.9)
(1.5)
(3.4)
Ozurdex
30
95
125
(12.6)
5.8
0.6
4.4
(0.4)
Lumigan/Ganfort
52
51
103
19.9
(15.4)
(0.8)
(15.2)
(0.7)
Alphagan/Combigan
—
36
36
(91.6)
(3.1)
(25.6)
(0.2)
(23.5)
Other Eye Care
144
106
250
(4.3)
(1.7)
(3.2)
0.9
(2.1)
Other Key Products
835
202
1,037
11.2
(4.4)
7.8
(5.8)
7.5
Mavyret
184
191
375
9.7
(5.1)
1.6
(6.5)
0.8
Creon
404
—
404
8.4
n/m
8.4
n/m
8.4
Linzess/Constella
247
11
258
17.4
10.8
17.1
10.3
17.1
a
"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
b
Reflects profit sharing for Imbruvica international revenues.
c
Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories.
n/m = not meaningful
AbbVie Inc.
Key Product Revenues
Six Months Ended June 30, 2025
(Unaudited)
% Change vs. 6M24
Net Revenues (in millions)
Reported
Operationala
U.S.
Int'l.
Total
U.S.
Int'l.
Total
Int'l.
Total
NET REVENUES
$21,741
$7,025
$28,766
7.9 %
6.0 %
7.4 %
8.3 %
8.0 %
Immunology
10,980
2,915
13,895
11.3
17.9
12.6
20.4
13.1
Skyrizi
6,762
1,086
7,848
69.2
46.9
65.8
49.6
66.2
Rinvoq
2,672
1,074
3,746
53.3
37.6
48.5
40.1
49.3
Humira
1,546
755
2,301
(62.6)
(20.8)
(54.7)
(18.4)
(54.3)
Neuroscience
4,305
660
4,965
19.3
27.4
20.3
29.8
20.6
Vraylar
1,661
4
1,665
13.4
41.8
13.5
47.4
13.5
Botox Therapeutic
1,498
296
1,794
17.0
5.2
14.9
8.6
15.5
Ubrelvy
563
15
578
33.0
46.7
33.3
51.2
33.4
Qulipta
409
51
460
49.5
>100.0
63.6
>100.0
63.6
Vyalev
28
133
161
n/m
>100.0
>100.0
>100.0
>100.0
Duodopa
40
153
193
(16.6)
(14.9)
(15.2)
(14.0)
(14.5)
Other Neuroscience
106
8
114
(10.4)
(12.7)
(10.5)
(8.1)
(10.2)
Oncology
2,053
1,256
3,309
2.4
7.1
4.2
9.1
5.0
Imbruvicab
1,072
420
1,492
(11.1)
(9.7)
(10.7)
(9.7)
(10.7)
Venclexta
633
723
1,356
9.1
7.8
8.4
11.3
10.3
Elahere
303
35
338
57.5
n/m
75.5
n/m
75.5
Epkinlyc
43
78
121
61.8
>100.0
92.1
>100.0
93.3
Other Oncology
2
—
2
n/m
n/m
n/m
n/m
n/m
Aesthetics
1,437
944
2,381
(12.3)
(5.6)
(9.8)
(3.6)
(9.0)
Botox Cosmetic
705
543
1,248
(15.9)
3.7
(8.4)
5.8
(7.6)
Juvederm Collection
180
311
491
(25.9)
(21.5)
(23.2)
(19.8)
(22.2)
Other Aesthetics
552
90
642
(1.0)
11.7
0.6
14.5
0.9
Eye Care
447
573
1,020
(4.2)
(5.3)
(4.8)
(1.8)
(2.8)
Ozurdex
60
188
248
(12.4)
0.8
(2.8)
2.7
(1.4)
Lumigan/Ganfort
100
109
209
39.4
(11.0)
7.5
(7.7)
9.6
Alphagan/Combigan
26
70
96
(3.6)
(13.1)
(10.6)
(8.5)
(7.2)
Other Eye Care
261
206
467
(12.8)
(4.4)
(9.3)
0.3
(7.3)
Other Key Products
1,471
375
1,846
2.5
(12.0)
(0.8)
(10.4)
(0.4)
Mavyret
326
355
681
4.9
(12.8)
(5.1)
(11.2)
(4.2)
Creon
759
—
759
15.4
n/m
15.4
n/m
15.4
Linzess/Constella
386
20
406
(17.4)
7.0
(16.5)
9.7
(16.4)
a
"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
b
Reflects profit sharing for Imbruvica international revenues.
c
Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories.
n/m = not meaningful
AbbVie Inc.
Consolidated Statements of Earnings
(Unaudited)
(in millions, except per share data)
Second Quarter
Ended June 30
Six Months
Ended June 30
2025
2024
2025
2024
Net revenues
$ 15,423
$ 14,462
$ 28,766
$ 26,772
Cost of products sold
4,346
4,202
8,348
8,296
Selling, general and administrative
3,253
3,377
6,546
6,692
Research and development
2,131
1,948
4,198
3,887
Acquired IPR&D and milestones
823
937
1,071
1,101
Other operating income
(24)
—
(24)
—
Total operating costs and expenses
10,529
10,464
20,139
19,976
Operating earnings
4,894
3,998
8,627
6,796
Interest expense, net
678
506
1,305
959
Net foreign exchange loss
23
1
27
5
Other expense, net
2,639
1,345
4,080
1,931
Earnings before income tax expense
1,554
2,146
3,215
3,901
Income tax expense
613
773
985
1,156
Net earnings
941
1,373
2,230
2,745
Net earnings attributable to noncontrolling interest
3
3
6
6
Net earnings attributable to AbbVie Inc.
$ 938
$ 1,370
$ 2,224
$ 2,739
Diluted earnings per share attributable to AbbVie Inc.
$ 0.52
$ 0.77
$ 1.24
$ 1.53
Adjusted diluted earnings per sharea
$ 2.97
$ 2.65
$ 5.43
$ 4.96
Weighted-average diluted shares outstanding
1,771
1,771
1,772
1,772
a
Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
1. Specified items impacted results as follows:
Quarter Ended June 30, 2025
(in millions, except per share data)
Earnings
Diluted
Pre-tax
After-taxa
EPS
As reported (GAAP)
$ 1,554
$ 938
$ 0.52
Adjusted for specified items:
Intangible asset amortization
1,864
1,571
0.89
Change in fair value of contingent consideration
2,795
2,709
1.53
Other
91
60
0.03
As adjusted (non-GAAP)
$ 6,304
$ 5,278
$ 2.97
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2025 included acquired IPR&Dand milestone expense of $823 million on a pre-tax and $737 million on an after-tax basis, representing an unfavorable impact of $0.42 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Quarter Ended June 30, 2025
(in millions)
Cost ofproducts sold
SG&A
R&D
Other operatingincome
Other expense,net
As reported (GAAP)
$ 4,346
$ 3,253
$ 2,131
$ (24)
$ 2,639
Adjusted for specified items:
Intangible asset amortization
(1,864)
—
—
—
—
Change in fair value of contingent consideration
—
—
—
—
(2,795)
Other
(69)
(14)
(16)
24
(16)
As adjusted (non-GAAP)
$ 2,413
$ 3,239
$ 2,115
$ —
$ (172)
3. The adjusted tax rate for the second quarter of 2025 was 16.2 percent, as detailed below:
Quarter Ended June 30, 2025
(dollars in millions)
Pre-tax earnings
Income taxes
Tax rate
As reported (GAAP)
$ 1,554
$ 613
39.4 %
Specified items
4,750
410
8.6 %
As adjusted (non-GAAP)
$ 6,304
$ 1,023
16.2 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
1. Specified items impacted results as follows:
Quarter Ended June 30, 2024
(in millions, except per share data)
Earnings
Diluted
Pre-tax
After-taxa
EPS
As reported (GAAP)
$ 2,146
$ 1,370
$ 0.77
Adjusted for specified items:
Intangible asset amortization
1,947
1,651
0.93
Acquisition and integration costs
145
125
0.07
Change in fair value of contingent consideration
1,476
1,438
0.81
Other
90
126
0.07
As adjusted (non-GAAP)
$ 5,804
$ 4,710
$ 2.65
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition.
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2024 included acquired IPR&Dand milestone expense of $937 million on a pre-tax and $924 million on an after-tax basis, representing an unfavorable impactof $0.52 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Quarter Ended June 30, 2024
(in millions)
Cost of products sold
SG&A
R&D
Other expense,net
As reported (GAAP)
$ 4,202
$ 3,377
$ 1,948
$ 1,345
Adjusted for specified items:
Intangible asset amortization
(1,947)
—
—
—
Acquisition and integration costs
(79)
(35)
(31)
—
Change in fair value of contingent consideration
—
—
—
(1,476)
Other
(41)
(27)
—
(22)
As adjusted (non-GAAP)
$ 2,135
$ 3,315
$ 1,917
$ (153)
3. The adjusted tax rate for the second quarter of 2024 was 18.8 percent, as detailed below:
Quarter Ended June 30, 2024
(dollars in millions)
Pre-tax earnings
Income taxes
Tax rate
As reported (GAAP)
$ 2,146
$ 773
36.0 %
Specified items
3,658
318
8.7 %
As adjusted(non-GAAP)
$ 5,804
$ 1,091
18.8 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
1. Specified items impacted results as follows:
Six Months Ended June 30, 2025
(in millions, except per share data)
Earnings
Diluted
Pre-tax
After-taxa
EPS
As reported (GAAP)
$ 3,215
$ 2,224
$ 1.24
Adjusted for specified items:
Intangible asset amortization
3,722
3,145
1.78
Change in fair value of contingent consideration
4,313
4,186
2.36
Other
153
93
0.05
As adjusted (non-GAAP)
$ 11,403
$ 9,648
$ 5.43
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2025 included acquired IPR&D and milestones expense of $1.1 billion on a pre-tax and $975 million on an after-tax basis, representing an unfavorable impactof $0.55 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Six Months Ended June 30, 2025
(in millions)
Cost of products sold
SG&A
R&D
Otheroperating income
Other expense,net
As reported (GAAP)
$ 8,348
$ 6,546
$ 4,198
$ (24)
$ 4,080
Adjusted for specified items:
Intangible asset amortization
(3,722)
—
—
—
—
Change in fair value of contingent consideration
—
—
—
—
(4,313)
Other
(97)
(27)
(32)
24
(21)
As adjusted (non-GAAP)
$ 4,529
$ 6,519
$ 4,166
$ —
$ (254)
3. The adjusted tax rate for the first six months of 2025 was 15.3 percent, as detailed below:
Six Months Ended June 30, 2025
(dollars in millions)
Pre-tax earnings
Income taxes
Tax rate
As reported (GAAP)
$ 3,215
$ 985
30.6 %
Specified items
8,188
764
9.3 %
As adjusted (non-GAAP)
$ 11,403
$ 1,749
15.3 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
1. Specified items impacted results as follows:
Six Months Ended June 30, 2024
(in millions, except per share data)
Earnings
Diluted
Pre-tax
After-taxa
EPS
As reported (GAAP)
$ 3,901
$ 2,739
$ 1.53
Adjusted for specified items:
Intangible asset amortization
3,838
3,254
1.84
Acquisition and integration costs
656
611
0.34
Change in fair value of contingent consideration
2,136
2,081
1.17
Other
111
145
0.08
As adjusted (non-GAAP)
$ 10,642
$ 8,830
$ 4.96
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition.
Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2024 included acquired IPR&Dand milestones expense of $1.1 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $0.60 to bothdiluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Six Months Ended June 30, 2024
(in millions)
Cost of productssold
SG&A
R&D
Interestexpense, net
Otherexpense, net
As reported (GAAP)
$ 8,296
$ 6,692
$ 3,887
$ 959
$ 1,931
Adjusted for specified items:
Intangible asset amortization
(3,838)
—
—
—
—
Acquisition and integration costs
(158)
(315)
(159)
(24)
—
Change in fair value of contingent consideration
—
—
—
—
(2,136)
Other
(57)
(30)
—
—
(24)
As adjusted (non-GAAP)
$ 4,243
$ 6,347
$ 3,728
$ 935
$ (229)
3. The adjusted tax rate for the first six months of 2024 was 17.0 percent, as detailed below:
Six Months Ended June 30, 2024
(dollars in millions)
Pre-tax earnings
Income taxes
Tax rate
As reported (GAAP)
$ 3,901
$ 1,156
29.6 %
Specified items
6,741
650
9.6 %
As adjusted (non-GAAP)
$ 10,642
$ 1,806
17.0 %
SOURCE AbbVie
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临床结果临床3期临床1期上市批准引进/卖出
2025-05-27
- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers.
"The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs."
An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase:
Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO.
Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC.
"The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis."
Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123:
In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO.
This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors.
Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4
Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO.
PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia.
"Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited."
Further information on AbbVie clinical trials is available at .
Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here.
Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.
Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses.
EPKINLY
®/TEPKINLY
® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.
U.S. Prescribing Information for AbbVie Medicines
Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv)
Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp)
Please see full Prescribing Information for IMBRUVICA® (ibrutinib)
Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets)
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, oncology, neuroscience and eye care – 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 (formerly Twitter) and YouTube.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit .
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 our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and 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 2024 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.
References:
Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois.
Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois.
Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138.
Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois.
Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070.
Contacts:
SOURCE AbbVie
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临床结果ASCO会议临床1期抗体药物偶联物临床2期
100 项与 ABBV-706 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 广泛期小细胞肺癌 | 临床3期 | - | 2025-12-06 | |
| 晚期恶性实体瘤 | 临床1期 | 美国 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 中国 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 日本 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 澳大利亚 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 法国 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 德国 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 以色列 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 意大利 | 2022-12-05 | |
| 晚期恶性实体瘤 | 临床1期 | 韩国 | 2022-12-05 |
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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期 | 广泛期小细胞肺癌 三线 | 二线 | 80 | (Relapsed/refractory SCLC + 1.8 mg/kg Q3W) | 簾夢願顧壓艱遞壓積鏇(鏇構積齋餘選壓構夢夢) = 選範鬱窪艱築鹽糧窪顧 獵餘鬱憲範築壓壓鹽構 (憲襯餘顧觸齋選衊憲齋 ) 更多 | 积极 | 2025-09-07 | |
(Relapsed/refractory SCLC + 2.5 mg/kg Q3W) | 簾夢願顧壓艱遞壓積鏇(鏇構積齋餘選壓構夢夢) = 簾願獵構艱蓋壓鹹積艱 獵餘鬱憲範築壓壓鹽構 (憲襯餘顧觸齋選衊憲齋 ) 更多 | ||||||
临床1期 | 神经内分泌肿瘤 SEZ6 expression | 191 | 範鬱齋膚膚繭齋鏇積範(築醖鏇構顧築蓋壓鏇顧) = 製鑰獵鹽鹽淵醖衊襯鹽 鹹鹹築夢網壓構製網窪 (獵窪鹽膚夢夢膚淵簾積 ) 更多 | 积极 | 2025-05-30 | ||
临床1期 | 神经内分泌癌 SEZ6 expression | ctDNA methylation profiles | 64 | 鹽範繭壓繭窪餘襯構鹽(顧顧繭膚簾餘醖鑰製糧) = 齋簾築鏇襯糧襯醖襯築 醖網憲鏇蓋襯鏇繭顧選 (衊蓋夢獵夢獵繭範網衊 ) | 积极 | 2025-05-30 | ||
临床1期 | 晚期恶性实体瘤 SEZ6 expression | 49 | 齋艱淵夢廠窪鹽壓鹽構(鑰憲廠構夢願獵淵憲鹹) = 醖蓋願製廠獵繭憲淵簾 製觸鬱壓鹹襯獵構簾廠 (憲選範襯夢憲製憲範顧 ) 更多 | 积极 | 2024-05-24 |
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