AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis Patients

• Data is supportive of early intervention in myelofibrosis to achieve improved clinical outcomes in spleen volume reduction (SVR), symptom score, bone marrow fibrosis (BMF), and anemia
• Results are from an exploratory analysis of navitoclax plus ruxolitinib from Cohort 3 of the Phase 2 REFINE study in JAK inhibitor naïve myelofibrosis patients

NORTH CHICAGO, Ill.,June 10, 2022/ PRNewswire/ -ABBVIE（NYSE：ABBV）今天宣布了其2阶段2阶段研究研究的新数据，研究了研究性Navitoclax与JAK抑制剂中的ruxolitinib结合使用的ruxolitinib幼稚患者（MF），这是一种罕见且难以治疗血液癌的血液癌（MF）。这些初步发现显示了该队列中脾脏的体积和症状改善。这些数据与先前观察到的来自1A的复发/难治性患者的数据一致¹和will be shared in an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress (Abstract #S197).²

REFINE is a Phase 2 non-randomized open-label multi-cohort study evaluating the safety and efficacy of navitoclax alone or in combination with ruxolitinib in MF.

"Current treatment options for myelofibrosis are limited and targeted toward controlling disease symptoms," saidMohamed Zaki医学博士，博士，Abbvie肿瘤学临床发展副总裁兼全球负责人。狗万正网地址“与临床前的发现一起，这项研究的早期结果表明，Navitoclax与ruxolitinib结合的抗纤维化活性是有希望的。具体而言，有关减少脾脏体积，症状和骨髓纤维化的减少的数据结果有助于支持进一步的疾病探索疾病的进一步探索。骨髓纤维化的修饰。”

The results presented at EHA 2022 were from a preliminary analysis of 32 JAK inhibitor naïve MF patients from Cohort 3 of the Phase 2 REFINE trial (NCT03222609).²The primary endpoint was spleen volume reduction of ≥35 percent (SVR35) from baseline at week 24.²Key secondary endpoints include ≥50 percent reduction in total symptom score (TSS50) at week 24, anemia response and BMF reduction.²

在结果中，在第24周（20/32）的可评估患者中，有63％的患者在治疗时（25/32）实现了SVR35。²At week 24, 41 percent (11/27) of evaluable patients with measurable baseline symptoms reached TSS50; notably, 67 percent of patients (18/27) met this endpoint at any time during the study.²In this cohort, 35 percent of evaluable patients, with available fibrosis grade at baseline and during the study, (9/26) achieved reduction in BMF by ≥1 grade at any time during the study with three patients experiencing ≥2 grade reductions in BMF.²此外，有40％的患者可评估贫血反应（6/15）的贫血改善，这是MF的常见临床特征。²

Preliminary safety analysis identified no new safety signals. Thirty-one (97 percent) patients reported one or more adverse event (AE).¹The most common Grade ≥3 AEs were thrombocytopenia (47 percent), anemia (34 percent), and neutropenia (25 percent).¹Seven patients (22 percent) reported experiencing serious AEs.¹三名患者（9％）经历了AE导致停用Navitoclax的AE，三名患者（9％）报告了AE导致违反鲁唑替尼中断。²

"These data reinforce the importance of early intervention in myelofibrosis and the potential to achieve improved clinical outcomes," said Francesco Passamonti, Full Professor of Hematology, University of Insubria and Chief, Hematology, Varee Hospital. "These preliminary results show good responses to combination therapy with navitoclax that may continue to improve over time."

关于Navitoclax
Navitoclax is an investigational, oral BCL-X_L/BCL-2抑制剂。Bcl-2蛋白质家族是凋亡途径的已知调节剂。³

Navitoclax目前尚未获得美国食品药品监督管理局（FDA）或任何卫生管理局的批准。作为正在进行的第2阶段和注册第三阶段研究的一部分，其安全性和功效正在评估。

Abbvie为研究性Navitoclax提供了广泛的后期临床试验计划，目前正在参加。有关参加临床试验的更多信息，请在这里拜访我们。

关于精炼研究
REFINE is a multi-cohort, Phase 2, randomized, open-label, multicenter study evaluating the tolerability and efficacy of navitoclax alone or when added to ruxolitinib in patients with myelofibrosis (MF).⁴The primary outcome measure is the percentage of patients who achieve Spleen Volume Reduction of greater than or equal to 35 percent (SVR35) from baseline to Week 24. Secondary outcomes measures include percentage of participants achieving 50 percent reduction in Total Symptom Score from baseline to Week 24 and change in grade of bone marrow fibrosis assessed according to the European Consensus Grading System.

Data presented at EHA 2022 include preliminary safety and efficacy results from Cohort 3 of REFINE (n=32). Patients in Cohort 3 had primary or secondary MF with splenomegaly and had not received JAK-2 therapy or BET inhibitors prior to enrollment. Data presented at EHA 2022 are representative of data from Cohort 3 of the REFINE study as ofFebruary 7, 2022。

Data included in the official EHA 2022摘要书are representative of data from Cohort 3 of the REFINE study as ofOctober 4，2021。

More information can be found onhttps://www.clinicaltrials.gov/(NCT03222609).

About Myelofibrosis
Myelofibrosis (MF) is a rare, difficult-to-treat blood cancer that results in excessive scar tissue formation (fibrosis) in the bone marrow. Patients living with MF experience symptoms such as an enlarged spleen, fatigue, weakness, and severe anemia, that are often debilitating and greatly impact quality of life. MF also carries a risk of transformation to more aggressive disease such as acute myeloid leukemia.⁴

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 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//www.worldcupnut.com/oncology。

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, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.worldcupnut.com。关注@abbvie推特,Facebook,Instagram,YouTube和LinkedIn。

前瞻性语句
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, among others, 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 indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

参考：

1. Ruxolitinib with Navitoclax Is Efficacious and Safe in Myelofibrosis. Cancer Discovery2022年5月1日; 12 (5): OF4.https://doi.org/10.1158/2159-8290.CD-RW2022-037。
2. Navitoclax plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: Preliminary safety and efficacy in a multicenter, open-label Phase 2 study. [Oral Presentation S197]. Presented at European Hematology Association 2022 Congress (EHA 2022),June 9-12, 2022。
3. Harrison C，Garcia J，Somervaille T等。在持续的鲁索利替尼治疗中添加Navitoclax，用于骨髓纤维化患者的进展或次优应：II期安全性和功效。J Clin Oncol。2022;JCO2102188。
4. Tsujimoto Y. (1998). Role of Bcl-2 family proteins in apoptosis: apoptosomes or mitochondria?. Genes to cells: devoted to molecular & cellular mechanisms, 3(11), 697–707.https://doi.org/10.1046/j.1365-2443.1998.00223.x

SOURCE AbbVie