RegulationPriority Review (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (AU), Conditional marketing approval (CN)

Structure/Sequence

Sequence Code 213022L

Source: *****

Sequence Code 10079093H

Source: *****

Clinical Trials associated with Mirvetuximab soravtansine

NCT06682988

/ Not yet recruitingPhase 3

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.
The total study duration will be approximately 24 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, and scans.

Start Date06 Feb 2025

Sponsor / Collaborator

AbbVie, Inc.

CTR20241552

/ RecruitingPhase 3

在二线含铂药物化疗联合贝伐珠单抗治疗后未出现疾病进展的FRα 高表达复发性铂类药物敏感上皮性卵巢癌、输卵管癌或原发性腹膜癌患者中评价mirvetuximab soravtansine 联合贝伐珠单抗对比贝伐珠单抗单药作为维持治疗的随机、多中心、开放性、III 期研究

[Translation] A randomized, multicenter, open-label, phase III study evaluating mirvetuximab soravtansine plus bevacizumab versus bevacizumab alone as maintenance therapy in patients with FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not progressed after second-line platinum-based chemotherapy plus bevacizumab

主要目的为在铂类药物化疗（双药）联合贝伐珠单抗治疗后随机接受贝伐珠单抗联合mirvetuximab soravtansine（MIRV，第1 组）与贝伐珠单抗（第2 组）单药维持治疗的患者中，比较无进展生存期（PFS）

[Translation]

The primary objective was to compare progression-free survival (PFS) in patients randomized to maintenance therapy with bevacizumab plus mirvetuximab soravtansine (MIRV, group 1) versus bevacizumab alone (group 2) after platinum-based chemotherapy (doublet) plus bevacizumab.

Start Date03 Sep 2024

Sponsor / Collaborator

BSP Pharmaceuticals SpA

[+3]

NCT06365853

/ RecruitingPhase 2

A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer [PSOC] or platinum-resistant ovarian cancer [PROC]) with high folate receptor alpha (FRα) expression.

Start Date29 Jul 2024

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Mirvetuximab soravtansine

100 Translational Medicine associated with Mirvetuximab soravtansine

100 Patents (Medical) associated with Mirvetuximab soravtansine

Literatures (Medical) associated with Mirvetuximab soravtansine

01 Mar 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL PATHOLOGY

Folate Receptor Immunohistochemical Staining and Gynecologic Tumors: Initial Experience With 216 Cases

Article

Author: Lawson, Barrett C ; Malpica, Anais ; Marques-Piubelli, Mario L ; Westin, Shannon N

Folate receptor alpha has been shown to have possible mechanisms of tumorigenesis in malignancies, becoming a potential target for therapy. Mirvetuximab soravtansine is an antifolate receptor alpha monoclonal antibody, with an approved FOLR1-2.1 immunohistochemical biomarker. After IRB approval, a retrospective review of gynecologic pathology cases was performed to identify cases in which FOLR1 immunohistochemistry (IHC) was performed at our institution over a period of 9 months as part of clinical care for therapy eligibility. Clinical data collected included patients’ age, tumor histotype, tumor grade, primary tumor site, FIGO stage, dates of recurrence/progression, and use of mirvetuximab therapy. FOLR1 IHC data were recorded, including the date specimen obtained, date IHC was performed, site tested, case type, percentage tumor staining, and intensity. Cases were deemed positive or negative according to current recommendations (75%, 2−3+intensity). Two hundred sixteen cases were identified. Patient ages ranged from 25 to 83 years old (median: 59 yr). Staining intensity was reported as 0 in 15 (6.9%) cases, weak (1+) in 8 (3.7%), moderate (2+) in 27 (12.5%), strong (3+) in 27 (12.5%), weak-to-moderate (1−2+) in 15 (6.9%), and moderate-to-strong (2−3+) in 99 (45.8%); intensity was not provided in 25 (11.6%). Percentage of tumor staining ranged from 0 to 100, with a median of 60. The IHC was overall deemed positive in 98 (45.4%) cases and negative in 118 (54.6%). By histotype, 5 of 17 (29.4%) low-grade serous carcinomas, 88 of 162 (54.3%) high-grade serous carcinomas, 3 of 5 (60%) of carcinosarcomas, and 2 of 6 (33.3%) of mixed carcinomas were positive. No case of clear cell CA, endometrioid CA, Mullerian CA NOS, serous borderline, mucinous CA, or granulosa cell tumor was positive. The primary site of disease was tubo-ovarian in 192 (88.9%) cases, peritoneal in 8 (3.7%) cases, uterine in 3 (1.4%) cases, and unknown in 13 (6%) cases. By site on which immunohistochemical stain was performed: primary site positive in 53 of 96 (55.2%) cases, metastatic site at time of diagnosis/debulking positive in 23 of 41 (52.1%) cases, and metastatic/recurrent cases positive in 22 of 79 (27.8%) cases. There was a statistically significant correlation when comparing the positivity rates between these sites (P = 0.0004). Survival data were examined with high-grade serous carcinoma, with no statistically significant difference between positive and negative cases in overall survival (P = 0.622) or progression-free survival (P = 0.711). Biopsy specimens were positive in 17 (25%) cases, while negative in 51 (75%), whereas resection specimens were positive in 81 (54.7%) and negative in 67 (45.3%), a statistically significant difference (P < 0.0001). Cases that were <19 months old had 38 (36.2%) positive and 67 (63.8%) negative, compared with cases ≥19 months old that had 60 (54.1%) positive and 51 (45.9%) negative, a statistically significant difference (P = 0.0084). Significant differences in FOLR1 staining were noted between histotypes, age of the specimen, type of case tested, and site of disease tested. Further testing is needed to help determine the best tissue to be utilized for this new biomarker.

01 Mar 2025·ANNALS OF ONCOLOGY

The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial

Article

Author: Ray-Coquard, I ; Wang, Y ; Corr, B R ; Murphy, C G ; Gálvez-Montosa, F ; Cecere, S C ; Bonaventura, A ; Barquín, A ; Oaknin, A ; Ayuk, S-M ; Rubio Pérez, M J ; Salutari, V ; Konecny, G E ; Diver, E J ; Lewin, S N ; Mathews, C A ; Alvarez Secord, A

BACKGROUND:

Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with United States Food and Drug Administration approval for FRα-positive platinum-resistant ovarian cancer. PICCOLO is a phase II, global, open-label, single-arm trial of MIRV as third-line or greater (≥3L) treatment in patients with FRα-positive (≥75% of cells with ≥2+ staining intensity) recurrent platinum-sensitive ovarian cancer (PSOC).

PATIENTS AND METHODS:

Participants received MIRV (6 mg/kg adjusted ideal body weight every 3 weeks) until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death. Primary endpoint was investigator-assessed objective response rate (ORR). Key secondary endpoint was investigator-assessed duration of response (DOR). Additional endpoints included investigator-assessed progression-free survival (PFS), overall survival (OS), and safety. Analyses of subgroups by disease characteristics (e.g. platinum-free interval) and treatment history [e.g. prior bevacizumab and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi) treatment] were exploratory.

RESULTS:

Seventy-nine participants were enrolled and efficacy assessable. The primary endpoint was met; ORR was 51.9% [95% confidence interval (CI) 40.4% to 63.3%]. Median DOR was 8.25 months (95% CI 5.55-10.78 months) and median PFS was 6.93 months (95% CI 5.85-9.59 months). OS was not mature at data cut-off. ORR was 45.8% (95% CI 32.7% to 59.2%) in participants with PD while on/within 30 days of prior PARPi (n = 59) and 60.0% (95% CI 14.7% to 94.7%) in those without PD with prior PARPi (n = 5). No new safety signals occurred; most common treatment-emergent adverse events (TEAEs) were gastrointestinal, neurosensory, and resolvable ocular events. TEAEs led to discontinuation in 13 participants (16%) and death in 2 participants (3%).

CONCLUSIONS:

MIRV as ≥3L treatment in heavily pretreated recurrent FRα-positive PSOC demonstrated notable efficacy and tolerable safety, including among those with prior PD on or within 30 days of PARPi (NCT05041257).

01 Mar 2025·ANNALS OF EMERGENCY MEDICINE

Antibody-Drug Conjugates: The Toxicities and Adverse Effects That Emergency Physicians Must Know

Review

Author: Markides, Danna Michelle ; Merlin, Jeffrey ; Hita, Angel Guido ; Reyes-Gibby, Cielto ; Yeung, Sai-Ching J

Antibody-drug conjugates are novel antineoplastic agents whose use is expanding, both in terms of the number of drugs and the number of patients being treated. This article reviews the known toxicities and complications of antibody-drug conjugates that are currently approved for the treatment of cancer in the United States, with a focus on their emergency presentation and management. Similar to many other cancer therapies, most antibody-drug conjugates can cause diarrhea, nausea/vomiting, rash, peripheral neuropathy, and cytopenia, which are generally treated following standard-of-care. Interstitial lung disease, which may mimic pneumonia and cause respiratory failure and death, has been seen with trastuzumab deruxtecan and mirvetuximab soravtansine; emergency treatment of this condition includes oxygenation, ventilatory support, and corticosteroids. Inotuzumab ozogamicin and gemtuzumab ozogamicin are both associated with sinusoidal obstruction syndrome, a potentially fatal liver dysfunction that presents with weight gain, fluid overload, and jaundice. Abnormal liver function tests in patients who have been recently treated with these agents should be cautiously evaluated. Cardiac adverse events with antibody-drug conjugates are rare, but trastuzumab emtansine and trastuzumab deruxtecan may cause a decrease in cardiac contractility, and heart rate corrected QT interval prolongation is a rare effect of trastuzumab deruxtecan. Ocular adverse events, especially blurred vision, and keratopathy, are common with mirvetuximab soravtansine and tisotumab vedotin. Progressive multifocal leukoencephalopathy has been reported with brentuximab vedotin and polatuzumab vedotin. Tumor lysis syndrome may occur after treatment with gemtuzumab ozogamicin, polatuzumab vedotin, and brentuximab vedotin. Patients receiving enfortumab vedotin or brentuximab vedotin may develop hyperglycemia, sometimes presenting as diabetic ketoacidosis. Tisotumab vedotin and trastuzumab emtansine are associated with bleeding; although it is minor in most cases, severe bleeding and intracranial hemorrhage have occurred. Several antibody-drug conjugates can cause an anaphylactoid infusion-related reaction, which occurs most commonly during or soon after infusion but may be delayed up to 24 hours. Further research is needed to establish the real-world incidence of rare complications and how often patients with these complications present to the emergency department.

149

News (Medical) associated with Mirvetuximab soravtansine

31 Jan 2025

·www.prnewswire.com

AbbVie Reports Full-Year and Fourth-Quarter 2024 Financial Results

Reports Full-Year Diluted EPS of $2.39 on a GAAP Basis, a Decrease of 12.1 Percent; Adjusted Diluted EPS of $10.12, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $1.52 Per Share Related to 2024 Acquired IPR&D and Milestones Expense Delivers Full-Year Net Revenues of $56.334 Billion, an Increase of 3.7 Percent on a Reported Basis and 4.6 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $26.682 Billion, an Increase of 2.1 Percent on a Reported Basis, or 2.9 Percent on an Operational Basis; Global Humira Net Revenues Were $8.993 Billion; Global Skyrizi Net Revenues Were $11.718 Billion; Global Rinvoq Net Revenues Were $5.971 Billion Full-Year Global Net Revenues from the Oncology Portfolio Were $6.555 Billion, an Increase of 10.8 Percent on a Reported Basis, or 12.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $3.347 Billion; Global Venclexta Net Revenues Were $2.583 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $8.999 Billion, an Increase of 16.6 Percent on a Reported Basis, or 16.9 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $3.283 Billion; Global Vraylar Net Revenues Were $3.267 Billion; Combined Global Ubrelvy and Qulipta Net Revenues were $1.664 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.176 Billion, a Decrease of 2.2 Percent on a Reported Basis, or 0.6 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.720 Billion; Global Juvederm Net Revenues Were $1.177 Billion Reports Fourth-Quarter Diluted Loss Per Share of $0.02 on a GAAP Basis, Inclusive of the Recent Partial Intangible Asset Impairment Charge Related to Emraclidine; Adjusted Diluted EPS of $2.16; These Results Include an Unfavorable Impact of $0.88 Per Share Related to Fourth-Quarter 2024 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.102 Billion, an Increase of 5.6 Percent on a Reported Basis and 6.1 Percent on an Operational Basis Provides 2025 Adjusted Diluted EPS Guidance Range of $12.12 to $12.32; Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense Reaffirms Expectations for High Single-Digit Compound Annual Revenue Growth Rate through 2029; Raises 2027 Combined Sales Outlook for Skyrizi and Rinvoq to More Than $31 Billion; Updates Outlook for Aesthetics to Deliver High Single-Digit Compound Annual Revenue Growth Rate from 2025 through 2029 NORTH CHICAGO, Ill., Jan. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2024. "2024 was a year of significant progress for AbbVie. Our growth platform delivered outstanding results, we advanced our pipeline with key regulatory approvals and promising data, and we strengthened our business through strategic transactions," said Robert A. Michael, chief executive officer, AbbVie. "We are entering 2025 with significant momentum and expect net revenues to exceed their previous peak in just the second full year following the U.S. Humira loss of exclusivity." Fourth -Quarter Results Worldwide net revenues were $15.102 billion, an increase of 5.6 percent on a reported basis, or 6.1 percent on an operational basis. Global net revenues from the immunology portfolio were $7.294 billion, an increase of 4.9 percent on a reported basis, or 5.3 percent on an operational basis. Global Humira net revenues of $1.682 billion decreased 49.1 percent on a reported basis, or 48.7 percent on an operational basis. U.S. Humira net revenues were $1.246 billion, a decrease of 54.5 percent. Internationally, Humira net revenues were $436 million, a decrease of 22.7 percent on a reported basis, or 20.5 percent on an operational basis. Global Skyrizi net revenues were $3.778 billion, an increase of 57.7 percent on a reported basis, or 57.9 percent on an operational basis. Global Rinvoq net revenues were $1.834 billion, an increase of 46.2 percent on a reported basis, or 47.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.691 billion, an increase of 12.0 percent on a reported basis, or 12.9 percent on an operational basis. Global Imbruvica net revenues were $848 million, a decrease of 6.2 percent, with U.S. net revenues of $625 million and international profit sharing of $223 million. Global Venclexta net revenues were $655 million, an increase of 11.0 percent on a reported basis, or 13.0 percent on an operational basis. Global Elahere net revenues were $148 million. Global net revenues from the neuroscience portfolio were $2.509 billion, an increase of 19.8 percent on a reported basis, or 19.9 percent on an operational basis. Global Botox Therapeutic net revenues were $873 million, an increase of 12.5 percent on a reported basis, or 13.0 percent on an operational basis. Global Vraylar net revenues were $924 million, an increase of 17.1 percent. Global Ubrelvy net revenues were $303 million, an increase of 29.6 percent. Global Qulipta net revenues were $201 million, an increase of 76.4 percent on a reported basis, or 76.2 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.298 billion, a decrease of 5.2 percent on a reported basis, or 4.4 percent on an operational basis. Global Botox Cosmetic net revenues were $687 million, a decrease of 4.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $279 million, a decrease of 16.3 percent on a reported basis, or 15.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 70.9 percent. The adjusted gross margin ratio was 83.8 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 25.5 percent of net revenues. The adjusted SG&A expense was 23.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 44.9 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues. Acquired IPR&D and milestones expense was 10.4 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was negative 9.9 percent. The adjusted operating margin was 34.7 percent. Net interest expense was $610 million. On a GAAP basis, the tax rate in the quarter was 99.0 percent. The adjusted tax rate was 20.2 percent. Diluted loss per share in the fourth quarter was $0.02 on a GAAP basis, inclusive of the recent partial intangible asset impairment charge related to emraclidine. Adjusted diluted EPS, excluding specified items, was $2.16. These results include an unfavorable impact of $0.88 per share related to acquired IPR&D and milestones expense. 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 European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first novel therapy approved in the European Union (EU) specifically for patients with FRα positive, platinum-resistant ovarian cancer. At the American Society of Hematology (ASH) Annual Meeting, AbbVie announced updated clinical trial results that showed Epkinly (epcoritamab) combination therapy demonstrated high response rates in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL). The company also announced new results from two ongoing clinical trials which showed Epkinly induced durable complete responses as monotherapy and combination treatment in patients with diffuse large B-cell lymphoma (DLBCL). Epkinly is being co-developed by AbbVie and Genmab. AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage AbbVie's oncology expertise and EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. AbbVie and Simcere Zaiming announced a partnership to develop a novel trispecific antibody candidate in multiple myeloma (MM). This option-to-license agreement will develop SIM0500, an investigational new drug candidate that is currently in Phase 1 clinical trials in patients with r/r MM. AbbVie and Neomorph announced a collaboration and license agreement that will leverage AbbVie's drug development expertise and Neomorph's leading molecular glue discovery platform to develop novel molecular glue degraders for multiple targets across oncology and immunology. AbbVie announced that it completed its acquisition of Nimble Therapeutics, strengthening AbbVie's pipeline and R&D capabilities. The transaction includes Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis (PsO) as well as Nimble's peptide synthesis, screening, and optimization platform used to help drive rapid discovery and optimization of peptide candidates for a range of targets. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease (PD). In the study, tavapadon met the primary endpoint, demonstrating a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. Tavapadon also met the key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score. Tavapadon has demonstrated positive results across all three Phase 3 TEMPO trials and AbbVie remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. AbbVie announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6. Following the results of these trials, AbbVie began an evaluation of the emraclidine intangible asset for impairment which resulted in a significant decrease in the estimated future cash flows for the product. Based on the revised cash flows, the company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion. AbbVie continues to evaluate information with respect to the Cerevel-related clinical development programs and will monitor the remaining intangible assets of $3.6 billion. AbbVie announced that it completed its acquisition of Aliada Therapeutics. The transaction strengthens AbbVie's neuroscience pipeline and R&D capabilities with the addition of a potential best-in-class disease-modifying therapy for Alzheimer's disease (AD), ALIA-1758, and novel blood-brain barrier (BBB)-crossing technology. Full-Year 2025 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2025 of $12.12 to $12.32. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2025, as both cannot be reliably forecasted. Long-Term Outlook AbbVie is reaffirming its expectations for a high single-digit compound annual revenue growth rate through 2029. This guidance assumes 2024 as the base year in the compound annual growth rate calculation. AbbVie is raising its long-term outlook for Skyrizi and Rinvoq revenues. The company now expects combined Skyrizi and Rinvoq 2027 revenues of more than $31 billion, an increase of approximately $4 billion compared to previous guidance for combined revenues of more than $27 billion in 2027. This guidance assumes Skyrizi revenues of more than $20 billion and Rinvoq revenues of more than $11 billion in 2027. AbbVie is also updating its outlook for aesthetics revenues. The company now expects a high single-digit compound annual revenue growth rate for aesthetics through 2029. This guidance assumes 2025 as the base year in the compound annual growth rate calculation. 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 and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . 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 fourth-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 2024 and 2023 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, and changes to laws and regulations applicable to our industry. 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 2023 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3License out/inPhase 1

17 Jan 2025

·www.prnewswire.com

Senaparib Approved by NMPA for 1L Maintenance Therapy in Ovarian Cancer

SHANGHAI, Jan. 16, 2025 /PRNewswire/ -- IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, is pleased to announce that Senaparib Capsules (派舒宁®）has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Senaparib, discovered and developed by IMPACT, is a potent and novel PARP 1/2 inhibitor. Its distinctive molecular structure provides it with high in vitro and in vivo activity, exceptional target selectivity and wide safety window. The approval is based on FLAMES Study. The study is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Senaparib as monotherapy for the maintenance treatment of patients with advanced ovarian cancer who had completed first-line chemotherapy and achieved either a complete response (CR) or partial response (PR). The results of FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. [1]The results also indicated that both HRD positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer. The top-line results of the study were initially presented as a late breaking oral presentation at ESMO in 2023 and presented at CSCO 2024. On May 15, 2024, the internationally renowned medical journal Nature Medicine also published the results titled "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial."[1] Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000. According to the latest national cancer statistics released by National Cancer Center in 2024, there were 61,100 new cases of ovarian cancer and 32,600 deaths in China in 2022, making it the most lethal gynecological tumor. Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 41.8%. [2]Although ovarian cancer may be resolved after initial platinum-containing chemotherapy, most patients inevitably face recurrence, and there remains a significant unmet clinical need for treatment in the ovarian cancer patient population. In recent years, PARP inhibitors are changing the therapeutic landscape of ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-containing chemotherapy and delaying disease recurrence. In December 2023, IMPACT entered into a collaboration agreement with Zhongmei Huadong Pharmaceutical Co., Ltd, a subsidiary of Huadong Medicine Co., Ltd (SZ.000963) (collectively, "Huadong Medicine") for the commercialization of Senaparib. Under the collaboration agreement, Huadong Medicine receives exclusive promotion rights of Senaparib in mainland China. Huadong Medicine is deeply involved in the field of gynecological oncology. Senaparib and Huadong Medicine's approved mirvetuximab soravtansine-gynx (ELAHERE®) can provide solutions for ovarian cancer patients with different stages of the disease, sharing expert networks, research and clinical resources, promoting and developing together to form an effective and highly synergistic relationship. Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT said: "It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT's in-house synthetic lethality R&D platform and the R&D execution team. Leveraging Huadong Medicine's extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer." About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage responses (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT's pipeline products include PARP inhibitor Senaparib (IMP4297), WEE1 inhibitor (IMP7068), ATR inhibitor (IMP9064), and PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The most advanced development program, PARP inhibitor Senaparib (IMP4297), has been in clinical Phase II/III studies globally, including China, in ovarian cancer, small cell lung cancer and other indications. The Phase III clinical study (FLAMES Study) of Senaparib for advanced ovarian cancer maintenance treatment following first-line therapy met primary endpoint, with best-in-class efficacy and safety profile. Based on the results of the FLAMES study, the National Medicines Products Administration (NMPA) has approved the new drug application for Senaparib. The Wee1 inhibitor IMP7068 and the ATR inhibitor IMP9064 have been investigated in Phase I clinical studies in several countries and regions around the world, including U.S. and China, and the recommended Phase II dose (RP2D) has been established. PARP1 selective inhibitor IMP1734 has obtained IND clearance from FDA and NMPA, as well as completed FPI in early 2024. For additional information, please visit IMPACT Therapeutics Contact: +86 21 6841 1121 [email protected] SOURCE IMPACT Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalLicense out/inPhase 1

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

100 Deals associated with Mirvetuximab soravtansine

External Link

KEGG	Wiki	ATC	Drug Bank
D10954	Mirvetuximab soravtansine	-	DB12489

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer	US	ImmunoGen, Inc.	14 Nov 2022
Folate receptor-alpha positive, platinumresistant fallopian tube cancer	US	ImmunoGen, Inc.	14 Nov 2022
Folate receptor-alpha positive, platinumresistant primary peritoneal cancer	US	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Epithelial Ovarian Carcinoma	US	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Fallopian Tube Carcinoma	US	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Primary Peritoneal Carcinoma	US	ImmunoGen, Inc.	14 Nov 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	Phase 3	-	AbbVie, Inc.	06 Feb 2025
Ovarian Cancer	Phase 3	US	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	CN	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	AR	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	AU	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	BE	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	BR	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	BG	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	CA	AbbVie, Inc.	27 Dec 2022
Ovarian Cancer	Phase 3	CZ	AbbVie, Inc.	27 Dec 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05041257 (PICCOLO, Pubmed \| Ann Oncol) Manual	Phase 2	Platinum-Sensitive Ovarian Carcinoma Third line FRα expression	79	Mirvetuximab Soravtansine	acotdyjwwc(wkgtyfkloj) = dzxzsfohal wtpcmwghfk (floqxnsjnq, 40.4 - 63.3) Met View more	Positive	01 Nov 2024
NCT05041257 (PICCOLO, ESMO2024) Manual	Phase 2	Primary peritoneal carcinoma \| Platinum-Sensitive Ovarian Carcinoma \| Fallopian Tube Carcinoma Third line FRα expression	79	Mirvetuximab soravtansine (MIRV) 6 mg/kg	olxmrmnznd(sxpbvjixxp) = lbfyntdfpd ngeijluqwn (csyyjsydjn, 40.4 - 63.3) View more	Positive	15 Sep 2024
NCT04209855 (MIRASOL, ESMO2024) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FRα expression	453	Mirvetuximab soravtansine (MIRV) 6 mg/kg	drllvdeldw(rsxzqknyvg) = ycocjcwhjd xkwctdabax (bcxdipigti, 4.3 - 6.0) View more	Positive	14 Sep 2024
NCT04209855 (MIRASOL, ESMO2024) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FRα expression	453	Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)	drllvdeldw(rsxzqknyvg) = mttrhxlxzl xkwctdabax (bcxdipigti, 2.9 - 4.5) View more	Positive	14 Sep 2024
NCT04296890 (SORAYA \| Study 0417 (SORAYA), CTgov)	Phase 3	Platinum-Resistant Fallopian Tube Carcinoma \| Ovarian Epithelial Carcinoma \| Peritoneal Neoplasms ... View more	106	Mirvetuximab Soravtansine	lfywjdngxd(zidxqyhtit) = ketqdmudxb uryfunjprp (jkwdbwhgmk, rzanxbyehw - czwnyxjptm) View more	-	07 Aug 2024
NCT04209855 (SORAYA \| MIRASOL \| SORAYA study (002) \| MIRASOL (GOG 3045/ENGOT-ov55), CTgov)	Phase 3	Platinum-Resistant Fallopian Tube Carcinoma \| Ovarian Epithelial Carcinoma \| Peritoneal Neoplasms ... View more	453	Mirvetuximab Soravtansine (Mirvetuximab Soravtansine)	ijascqluef(agtetvkhsz) = tlegimsnfx exzbktwbfb (ontxsxqocs, owskxvldcf - uvrfelxnvi) View more	-	01 Aug 2024
	Phase 3		453	Pegylated liposomal doxorubicin+Paclitaxel+Topotecan (Investigator's Choice (IC) Chemotherapy)	ijascqluef(agtetvkhsz) = ilrimkdego exzbktwbfb (ontxsxqocs, brwuwnuzkp - evqagiwwjx) View more	-	01 Aug 2024
NCT05445778 (GLORIOSA, Pubmed \| Future Oncol) Manual	Phase 3	Platinum-Sensitive Ovarian Carcinoma Maintenance FRα-high	-	Mirvetuximab soravtansine plus bevacizumab	lelubpoxtf(hplolhbezr) = hkqiafdbuw slbiazpofn (lycdvlsgqx, 41 - 89) View more	Positive	31 Jul 2024
NCT04209855 (MIRASOL (GOG 3045/ENGOT-ov55), ASCO2024)	Phase 3	Platinum-Resistant Ovarian Carcinoma folate receptor-alpha (FRα)	453	Mirvetuximab soravtansine (MIRV) 6 mg/kg	kzeytdfagy(naqirajbum): HR = 0.62 View more	Positive	24 May 2024
NCT04209855 (MIRASOL (GOG 3045/ENGOT-ov55), ASCO2024)	Phase 3		453	Investigator’s choice chemotherapy (ICC)	kzeytdfagy(naqirajbum): HR = 0.62 View more	Positive	24 May 2024
NCT02631876 \| NCT04296890 \| NCT04209855 \| NCT01609556 (ASCO2024)	Not Applicable	Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer folate receptor alpha-positive	682	Mirvetuximab soravtansine 6 mg/kg	gcawzitaos(ahunoujcwo) = 60.9% jtfxzfczns (wgixnutopl ) View more	Positive	24 May 2024
NCT03835819 (AACR2024) Manual	Phase 2	Endometrial Carcinoma Maintenance Microsatellite Stable (MSS)	16	IMGN853Mirvetuximab soravtansine (IMGN853)pembrolizumabsine (IMGN853)	vycdulpfdg(ftpsfkjdgl) = ggmsjspipw znurtedssi (kuqjoazpsl, 15.2 - 64.6) View more	Positive	05 Apr 2024
NCT04209855 (MIRASOL, ESGO2023) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FOLR1 Positive	453	Mirvetuximab soravtansine	uvuiaczbvu(jsbawhsnza): HR = 0.61 (95% CI, 0.45 - 0.81) View more	Positive	27 Sep 2023
NCT04209855 (MIRASOL, ESGO2023) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FOLR1 Positive	453	Mirvetuximab soravtansinetherapy		Positive	27 Sep 2023

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