Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug. PVEK is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. Giving PVEK with the FLAG-Ida regimen may be a safe and effective treatment for patients with acute myeloid leukemia and other high-grade myeloid neoplasms.

Start Date18 Dec 2023

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT05320380

/ WithdrawnPhase 1/2IIT

A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia

This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other chemotherapy without causing severe side effects, studies what kind of side effects IMGN632 may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause the leukemia to stop growing or to shrink for a period of time.

Start Date01 Aug 2023

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

[+2]

NCT04086264

/ Active, not recruitingPhase 1/2

A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

Start Date06 Nov 2019

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Pivekimab Sunirine

100 Translational Medicine associated with Pivekimab Sunirine

100 Patents (Medical) associated with Pivekimab Sunirine

Literatures (Medical) associated with Pivekimab Sunirine

01 Jan 2025·HemaSphere

Article

Author: Lock, Richard B. ; Bult, Carol J. ; Jocoy, Emily L. ; Mohamed, Sara M. A. ; Gifford, Andrew J. ; Evans, Kathryn ; Zweidler‐McKay, Patrick A. ; Philip, Vivek M. ; Lakshmikanthan, Sribalaji ; Neuhauser, Steven ; Smith, Malcolm A. ; Watts, Ben ; Earley, Eric J. ; Erickson, Stephen W. ; Smith, Christopher M. ; Stearns, Timothy M. ; Teicher, Beverly A. ; Chuang, Jeffrey H.

Abstract:

Antibody–drug conjugates (ADCs) combining monoclonal antibodies with cytotoxic payloads are a rapidly emerging class of immune‐based therapeutics with the potential to improve the treatment of cancer, including children with relapse/refractory acute lymphoblastic leukemia (ALL). CD123, the α subunit of the interleukin‐3 receptor, is overexpressed in ALL and is a potential therapeutic target. Here, we show that pivekimab sunirine (PVEK), a recently developed ADC comprising the CD123‐targeting antibody, G4723A, and the cytotoxic payload, DGN549, was highly effective in vivo against a large panel of pediatric ALL patient‐derived xenograft (PDX) models (n = 39). PVEK administered once weekly for 3 weeks resulted in a median event‐free survival (EFS) of 57.2 days across all PDXs. CD123 mRNA and protein expression was significantly higher in B‐lineage (n = 65) compared with T‐lineage (n = 25) ALL PDXs (p < 0.0001), and mice engrafted with B‐lineage PDXs achieved significantly longer EFS than those engrafted with T‐lineage PDXs (p < 0.0001). PVEK treatment also resulted in significant clearance of human leukemia cells in hematolymphoid organs in mice engrafted with B‐ALL PDXs. Notably, our results showed no direct correlation between CD123 expression and mouse EFS, indicating that CD123 is necessary but not sufficient for in vivo PVEK activity. Importantly, a PDX with very high CD123 cell surface expression but resistant to in vivo PVEK treatment, failed to internalize the G4723A antibody while remaining sensitive to the PVEK payload, DGN549, suggesting a novel mechanism of resistance. In conclusion, PVEK was highly effective against a large panel of B‐ALL PDXs supporting its clinical translation for B‐lineage pediatric ALL.

01 Mar 2024·The Lancet. Oncology

Article

Author: Lane, Andrew A ; Du, Yining ; Zweidler-McKay, Patrick A ; Todisco, Elisabetta ; Wang, Eunice S ; Konopleva, Marina Y ; Pemmaraju, Naveen ; DeAngelo, Daniel J ; Papadantonakis, Nikolaos ; Malcolm, Kara E ; Thompson, James E ; Kantarjian, Hagop M ; Montesinos, Pau ; Sloss, Callum M ; Sweet, Kendra L ; Bedse, Gaurav ; Daver, Naval G ; Torres-Miñana, Laura ; Watkins, Krystal

BACKGROUND:

Pivekimab sunirine (IMGN632) is a first-in-class antibody-drug conjugate comprising a high-affinity CD123 antibody, cleavable linker, and novel indolinobenzodiazepine pseudodimer payload. CD123 is overexpressed in several haematological malignancies, including acute myeloid leukaemia. We present clinical data on pivekimab sunirine in relapsed or refractory acute myeloid leukaemia.

METHODS:

This first-in-human, phase 1/2 dose-escalation and dose-expansion study enrolled participants aged 18 years or older at nine hospitals in France, Italy, Spain, and the USA with CD123+ haematological malignancies (Eastern Cooperative Oncology Group performance status of 0-1); participants reported here were in a cohort of participants with acute myeloid leukaemia who were refractory to or had relapsed on one or more previous treatments for acute myeloid leukaemia. The 3 + 3 dose-escalation phase evaluated two dosing schedules: schedule A (once every 3 weeks, on day 1 of a 3-week cycle) and fractionated schedule B (days 1, 4, and 8 of a 3-week cycle). The dose-expansion phase evaluated two cohorts: one cohort given 0·045 mg/kg of bodyweight (schedule A) and one cohort given 0·090 mg/kg of bodyweight (schedule A). The primary endpoints were the maximum tolerated dose and the recommended phase 2 dose. Antileukaemia activity (overall response and a composite complete remission assessment) was a secondary endpoint. The study is ongoing and registered with ClinicalTrials.gov, NCT03386513.

FINDINGS:

Between Dec 29, 2017, and May 27, 2020, 91 participants were enrolled (schedule A, n=68; schedule B, n=23). 30 (44%) of schedule A participants were female and 38 (56%) were male; 60 (88%) were White, six (9%) were Black or African American, and two (3%) were other races. Pivekimab sunirine at doses of 0·015 mg/kg to 0·450 mg/kg in schedule A was administered in six escalating doses with no maximum tolerated dose defined; three dose-limiting toxicities were observed (reversible veno-occlusive disease; 0·180 mg/kg, n=1 and 0·450 mg/kg, n=1; and neutropenia; 0·300 mg/kg, n=1). Schedule B was not pursued further on the basis of comparative safety and antileukaemia findings with schedule A. The recommended phase 2 dose was selected as 0·045 mg/kg once every 3 weeks. At the recommended phase 2 dose (n=29), the most common grade 3 or worse treatment-related adverse events were febrile neutropenia (three [10%]), infusion-related reactions (two [7%]), and anaemia (two [7%]). Treatment-related serious adverse events occurring in 5% or more of participants treated at the recommended phase 2 dose were febrile neutropenia (two [7%]) and infusion-related reactions (two [7%]). Among 68 participants who received schedule A, one death (1%) was considered to be treatment-related (cause unknown; 0·300 mg/kg cohort). At the recommended phase 2 dose, the overall response rate was 21% (95% CI 8-40; six of 29) and the composite complete remission rate was 17% (95% CI 6-36; five of 29).

INTERPRETATION:

Pivekimab sunirine showed single-agent activity across multiple doses, with a recommended phase 2 dose of 0·045 mg/kg once every 3 weeks. These findings led to a phase 1b/2 study of pivekimab sunirine plus azacitidine and venetoclax in patients with CD123-positive acute myeloid leukaemia.

FUNDING:

ImmunoGen.

01 Jan 2024·Revista espanola de patologia : publicacion oficial de la Sociedad Espanola de Anatomia Patologica y de la Sociedad Espanola de Citologia

Diagnóstico clínico-patológico de la neoplasia de células dendríticas plasmocitoides blásticas: reporte de 3 casos

Author: Llavador, Margarita ; Rienda, Iván ; Martínez-Cózar, Vicent ; Torres-Navarro, Ignacio

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease with a poor prognosis. It frequently affects the skin; indeed, dermal lesions may be the first clinical manifestation. We report three cases of BPDCN where the patients presented with skin lesions and describe the clinical, histopathological and immunohistochemical findings, its molecular characteristics and metastatic work-up. One of the patients remains in a clinical trial with IMGN632, a molecule directed against CD123, while the other two patients died after different therapeutic regimens. BPDCN is a complex diagnostic challenge which, together with its poor prognosis, requires close clinical-pathological cooperation in order to accelerate its diagnosis and offer early therapeutic alternatives with drugs directed against specific molecular targets.

News (Medical) associated with Pivekimab Sunirine

10 Dec 2023

·www.biospace.com

ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH

Pivekimab Triplet Demonstrates Encouraging CR, Composite CR, and MRD Negativity Rates; Broad Anti-Leukemia Activity Observed Across All Molecular Subsets Evaluated Pivekimab-Containing Triplet Well-Tolerated with Manageable Safety Pro > Data Support Continued Development of Triplet; Enrollment and Follow-Up Ongoing WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced new safety and efficacy findings from the newly diagnosed (ND) cohorts of the Phase 1b/2 study of pivekimab sunirine (pivekimab) in combination with azacitidine (Vidaza®) and venetoclax (Venclexta®), (pivekimab triplet) in patients with ND acute myeloid leukemia (AML). These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California. “We are pleased to share these new findings at ASH, which demonstrate encouraging anti-leukemia activity of the pivekimab triplet in newly diagnosed AML, a disease in which long-term survival unfortunately remains limited,” said Naval Daver, MD, Associate Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. “The MRD negativity rates, which are indicative of a deep remission, are particularly promising in the treated patient population. This encouraging activity, along with a manageable safety profile, support the continued evaluation of this novel triplet in this setting.” PIVEKIMAB SUNIRINE, A CD123-TARGETING ANTIBODY-DRUG CONJUGATE, IN COMBINATION WITH AZACITIDINE AND VENETOCLAX IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA Lead Author: Navel Daver, MD Poster Session: 616 (Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II) Date and Time: Sunday, December 10, 2023, 6:00-8:00 p.m. PT / 9:00-11:00 p.m. ET Publication Number: 2906 In the open-label, multicenter, Phase 1b/2 study of pivekimab in combination with azacitidine and venetoclax in patients with ND CD123-positive AML, patients received the recommended Phase 2 dose of pivekimab at 0.045 mg/kg on day 7, azacitidine at 75 mg/m2 daily on days 1-7, and venetoclax at up to 400 mg for at least 14 days or up to 28 days, based on cohort assignment, in a 28-day cycle. The primary endpoints are complete remission (CR) rate, composite CR rate (CCR [CR+CRh+CRp+CRi]), minimal residual disease (MRD) negativity rate, and duration of remission. Key secondary endpoints are safety, pharmacokinetics, and immunogenicity. Key findings for 50 ND patients (n=25 per cohort) as of September 29, 2023 (data cut-off) include: Anti-Leukemia Activity In the overall population, CCR rate was 68% (34/50), CR rate was 54% (27/50), and MRD negativity rate among evaluable patients achieving CCR was 76% (22/29). MRD was assessed centrally by flow cytometry with <0.1% considered negative. Response rates and MRD negativity were numerically comparable between cohorts 1 and 2, despite differences in the venetoclax schedule. In a post hoc subset analysis of patients unfit for intensive chemotherapy (i.e. patients >75 years of age, and/or with pre-specified comorbidities) (n=23), CCR rate was 78% (18/23), CR rate was 61% (14/23), and MRD negativity rate was 79% (11/14). In patients known to be TP53wt (n=25), CCR rate was 88% (22/25), CR rate was 84% (21/25), and MRD negativity rate was 80% (16/20). CCR and MRD negativity rates, respectively, were high across other major molecular subsets, including: FLT3 (ITD or TKD): 100% (6/6) and 100% (6/6) IDH1 mutant: 100% (4/4) and 67% (2/3) IDH2 mutant: 100% (6/6) and 83% (5/6) NPM1 mutant: 100% (8/8) and 86% (6/7) K/NRAS mutant: 50% (3/6) and 67% (2/3) TP53 mutant: 50% (7/14) and 50% (3/6) Among all MRD negative patients, the median time to MRD negativity was 1.87 months (range: 0.79-5.16 months). Although follow-up duration was short (median 5.2 months), landmark overall survival estimate at 6 months is 86%. The study is continuing to enroll newly diagnosed unfit AML patients. Safety The triplet displayed a manageable safety profile; no new safety signals were observed compared to previously reported data. The most common non-hematologic treatment-emergent adverse events (TEAEs) (all grades [grade 3+]) seen in ≥20% of all patients were constipation (48% [2%]), peripheral edema (44% [4%]), diarrhea (40% [2%]), hypophosphatemia (34% [2%]), nausea (32% [4%]), hypokalemia (28% [4%]), fatigue (24% [6%]), hypotension (24% [2%]), and pyrexia (24% [0%]). In the overall population: Rates of cytopenias were similar to those observed with azacitidine and venetoclax, with a median neutrophil recovery to ≥500/µL and platelet recovery to ≥50,000/µL by day 34 and day 22, respectively. No veno-occlusive disease, capillary leak syndrome, or sinusoidal obstruction syndrome were observed. Infusion-related reactions (IRRs) occurred in 16% of patients (0 grade 3+ IRRs). Discontinuations due to an adverse event (AE) were 4% (2 patients). 30-day mortality was 0%. 60-day mortality was 4% (2 patients; due to pneumonia and early disease progression). "Building upon our initial findings in frontline AML presented last year, these data show broad and consistent response rates in a larger study population and across major molecular subsets of interest, including those patients with biological mutations making them high-risk," said Michael Vasconcelles, MD, ImmunoGen's Executive Vice President, Research, Development, and Medical Affairs. "We are pleased with the low early mortality and manageable safety pro in particular the lack of prolonged cytopenias. We look forward to continuing to expand our cohort of newly diagnosed unfit patients to inform the development path for pivekimab in AML.” PRECLINICAL POSTERS ImmunoGen is also presenting two preclinical posters at ASH. Title: Venetoclax Synergizes with IMGN632, a Novel CD123-Targeting Antibody Conjugated to a DNA Alkylating Payload, By Suppressing DNA Damage Response and Potentiating Apoptosis in Acute Myeloid Leukemia in Vitro Models Presenter: Anna Skwarska Session: 604 (Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III) Date and Time: Monday, December 11, 2023, 6:00-8:00 p.m. PT / 9:00-11:00 p.m. ET Publication Number: 4155 Title: Spatial Response to Pivekimab Sunirine In Vivo in a BPDCN Model Presenter: Margaux Poussard Session: 604 (Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II) Date and Time: Sunday, December 10, 2023, 6:00-8:00 p.m. PT / 9:00-11:00 p.m. ET Publication Number: 2791 Additional information can be found at , including abstracts. ABOUT PIVEKIMAB SUNIRINE Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with azacitidine (Vidaza®) and venetoclax (Venclexta®) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen's novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single-strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the US. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN. ABOUT ACUTE MYELOID LEUKEMIA (AML) AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the US alone, more than 20,000 people will be diagnosed with AML and more than 11,000 will die from the disease this year. ABOUT CD123 CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a clinically validated therapeutic target. ABOUT IMMUNOGEN ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability pro we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™. Learn more about who we are, what we do, and how we do it at . Vidaza® and Venclexta® are registered trademarks of their respective owners. FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. These statements include, but are not limited to, the potential efficacy and safety of pivekimab. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of clinical trials and regulatory processes; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company's Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on April 28, 2023 and July 31, 2023 and November 2, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law. View source version on businesswire.com: Contacts INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600 anabel.chan@immunogen.com MEDIA ImmunoGen Courtney O'Konek 781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting Robert Stanislaro 212-850-5657 robert.stanislaro@fticonsulting.com Source: ImmunoGen Inc. View this news release online at:

Clinical ResultOrphan DrugBreakthrough TherapyImmunotherapyASH

30 Nov 2023

·medcitynews.com

AbbVie Tries Its Hand at ADCs Again With $10.1B Immunogen Acquisition

The Big Pharma world saw yet another multibillion-dollar deal in the hot field of antibody drug conjugates (ADCs) on Thursday. AbbVie announced plans to acquire ImmunoGen — and the Massachusetts-based biotech’s recently approved ADC treatment for ovarian cancer — for $10.1 billion in cash. A year ago, ImmunoGen’s ovarian cancer drug, named Elahere, became the first ADC approved by the FDA to treat ovarian cancer. By acquiring this asset, North Chicago-based AbbVie is seeking to strengthen its presence in the solid tumor space — a move the company is making as its two most profitable drugs, Humira and Imbruvica, begin to face daunting competition. Humira’s exclusivity expired this year, and Imbruvica sales are down due to the introduction of BeiGene’s oral treatment Brukinsa. The deal follows several other large acquisitions that have occurred in the ADC space this year. Pfizer announced its $43 billion acquisition of Seagen, which is considered an ADC pioneer, in March. In October, Merck announced a joint development and commercialization deal for three Daiichi Sankyo ADC treatments — if milestones are met, Merck could end up paying Daiichi Sankyo up to $22 billion. Some other examples of large drugmakers that have recently picked up ADC assets include Bristol Myers Squibb, AstraZeneca, GSK and BioNTech. ADCs are a popular target for pharma acquisitions because they boast promising potential to make cancer treatment more effective. These drugs deliver toxic payloads directly to cancer cells, aiming to minimize damage to healthy cells and improve precision when attacking tumors. Elahere is meant to treat ovarian cancer patients who have demonstrated a resistance to platinum-based chemotherapies. The drug targets folate receptor alpha, a protein that is often overexpressed on the surface of ovarian cancer cells. The ADC is approved for use in ovarian cancer patients who have a high expression of this protein and have also already received one to three prior treatment regimens. The drug generated $212 million in sales during the first three quarters of 2023. By buying an ADC that is already on the market, AbbVie could be trying to avoid the fate it suffered after its first big ADC deal. In 2016, AbbVie paid $5.8 billion to acquire cancer drugmaker Stemcentrx and its lead ADC candidate, Rova-T. The deal was meant to beef up AbbVie’s cancer portfolio with a lucrative drug, but Rova-T ended up failing multiple small cell lung cancer trials. In 2019, AbbVie admitted that the drug wasn’t going anywhere and eliminated the entire development program. One industry expert — Dave Latshaw, former AI drug development lead at Johnson & Johnson and current CEO of BioPhy — thinks AbbVie’s new deal signals that it is ready to move on from the Stemcentrx flop. “The acquisition of ImmunoGen shows Abbvie’s commitment to ADCs and highlights their willingness to push past previous strategic blunders in the same modality. While the move looks to be primarily about Elahere, which has shown great clinical results in ovarian cancer, the price highlights that they are confident in the rest of ImmunoGen’s pipeline as well and generally bullish on the ADC space,” he wrote in an email. With the acquisition, AbbVie gains access to the ImmunoGen’s pipeline of ADCs along with Elahere. Two of the most notable assets in the pipeline include IMGN-151, another ADC to treat ovarian cancer, and pivekimab sunirine, which targets a rare blood cancer. Damien Conover, director of healthcare equity research for Morningstar, wrote in an emailed statement that he thinks AbbVie “is largely paying a fair price” for ImmunoGen. He projects that Elahere’s peak annual sales will be close to $2 billion. Conover anticipates widespread adoption of Elahere among ovarian cancer patients whose initial treatment proved ineffective. This expectation is grounded in the findings of a recent phase 3 study, which revealed that the drug reduced tumor size and extended the lifespan of ovarian cancer patients when compared to traditional chemotherapy options. “Additional studies in platinum-sensitive ovarian cancer patients should come out over the next few years and could potentially almost double the market size, adding upside potential to our projection if the data is positive,” Conover wrote. He also believes the deal will help drive adjusted-earnings growth over the next five years, which is crucial considering how Humira biosimilars will likely create a drag on earnings for several years. Another industry leader — Trilliant Health CEO Hal Andrews — also thinks that the deal seems like a solid one. “Pharmaceutical companies have access to data earlier than everyone else, and their M&A activity is a reliable indicator of emerging disease trends. Given national trends of increasing cancer mortality in the 30-39, this transaction makes a ton of sense,” he wrote via email. The deal is expected to close in mid-2024, subject to regulatory approval.

AcquisitionDrug ApprovalImmunotherapyPhase 3ADC

30 Nov 2023

·www.biopharmadive.com

AbbVie joins ADC dealmaking with $10B ImmunoGen buyout

AbbVie is expanding its investment in targeted cancer medicines, announcing Thursday a $10.1 billion deal to acquire ImmunoGen, a pioneer in the field of so-called antibody-drug conjugates, and its newly approved ovarian cancer treatment Elahere.The transaction is this years third-largest biotechnology buyout and comes as AbbVies oncology business is sputtering. Revenues for the companys flagship drug Imbruvica have shrunk by more than one-fifth year over year through the first nine months of 2023, as competing therapies with fewer side effects have taken market share.Elahere gives AbbVie an on-market drug that could help boost sales as the company awaits clinical trial results and the potential approval of experimental cancer drugs in its pipeline.Robert Michael, AbbVies chief operating officer, highlighted Elaheres rapid market adoption on a Thursday call with investors. Sales, he noted, are already annualizing above $400 million, which he said would put it on track to be one of the most successful new product launches in oncology.Elahere would also be the only drug in AbbVies portfolio approved to treat a solid tumor, rather than the blood cancers that Imbruvica and AbbVies other marketed medicines target.It has been a strategic priority for AbbVie to establish a strong foundation in solid tumors, said AbbVie CEO Rick Gonzalez on the Thursday call.ImmunoGens focus on so-called antibody-drug conjugates, which combine targeting antibodies with cancer-killing chemotherapy, matches AbbVies own research strategy. The company has emphasized development of the medicines, known as ADCs for short, and lists five in its pipeline.Per deal terms, AbbVie will pay $31.26 per ImmunoGen share in cash, representing a 95% premium over Wednesdays closing price. The stock was already at its highest level since 2015 before AbbVies offer was made public.Founded in 1981, ImmunoGen was an early innovator in the ADC field, developing the targeting biological molecules, the tumor killing chemical payload and the molecules that link them.Its technology helped make possible the Roche drug Kadcyla and the Sanofi drug Sarclisa. Still, its own drug development efforts didnt bear fruit until the Food and Drug Administration last year gave conditional approval to Elahere.The drug is now used for people with ovarian cancer whose disease has progressed despite one to three rounds of chemotherapy and whose tumors have high levels of a protein called folate receptor alpha. AbbVie estimates a majority of ovarian cancer patients have this biomarker.A confirmatory trial of the drug recently succeeded, showing treatment reduced the risk of progression or death compared with chemotherapy in patients whose disease has worsened following at least one round of chemotherapy.ImmunoGen is also approaching an important data readout for a second experimental drug called pivekimab sunirine in a rare bone marrow and blood cancer. That medicine is also in earlier testing for leukemia.The biotechs antibody-drug conjugates will join in late-stage testing of AbbVies most advanced ADC, telisotuzumab vedotin, which is in lung cancer trials.The $10.1 billion deal continues pharmas lavish spending on ADC developers. Pfizer earlier this year agreed to pay $43 billion to acquire Seagen, another pioneer in the field, while Merck & Co. signed a big collaboration deal with Daiichi Sankyo worth $5.5 billion over the first two years.In 2020, Gilead spent $21 billion to buy Immunomedics, which had developed and launched an ADC called Trodelvy in breast cancer.The Pfizer and AbbVie ADC acquisitions have bookended a year in which drugmakers have so far spent more than $111 billion on acquisitions, the most since 2019 according to BioPharma Dive data. '

ADCAcquisitionDrug ApprovalImmunotherapy

100 Deals associated with Pivekimab Sunirine

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent B Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Recurrent Mixed Phenotype Acute Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory acute myeloid leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory B Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory Mixed Phenotype Acute Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory T Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Relapsing acute myeloid leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
CD123 Positive Acute Myeloid Leukemia	Phase 2	United States	AbbVie, Inc.	02 Jan 2018
CD123 Positive Acute Myeloid Leukemia	Phase 2	France	AbbVie, Inc.	02 Jan 2018
CD123 Positive Acute Myeloid Leukemia	Phase 2	Germany	AbbVie, Inc.	02 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Phase 1/2	CD123 Positive Acute Myeloid Leukemia CD123-positive	-	Pivekimab sunirine (PVEK)	naaqwfskag(oldzfqelky) = qgazwhowrp ljwajqylxp (nbytogzavf )	-	14 May 2024
NCT03386513 (Literature) Manual	Phase 1/2	Acute Myeloid Leukemia Interleukin-3 Receptor Subunit Alpha Positive	91	IMGN632	rmxypbxiso(jnvnwkxmbf) = zldtvcqsrt luxezhhtgh (aoyzjlsftn ) View more	Positive	01 Mar 2024
ASH2023	Phase 1/2	Acute Myeloid Leukemia	50	Pivekimab Sunirine (PVEK)	zcwjbasqaa(bhjmrqblbz) = xwwanqcgms hrtyaconhh (ngzjkvarjw ) View more	-	10 Dec 2023
NCT04086264 (ASH 12022 \| ASH 22022) Manual	Phase 1/2	Relapsing acute myeloid leukemia	71	Azacitidine+Venetoclax+Pivekimab Sunirine	svxaklitmc(njjkfdqihz) = zgyucqkarc qcrehfsuqj (vdozvnnhpg ) View more	Positive	15 Nov 2022
NCT04086264 (AML-262, Pubmed \| Clin Lymphoma Myeloma Leuk)	Phase 1/2	Relapsing acute myeloid leukemia	-	Pivekimab sunirine (PVEK)	xqvbzzewpt(yclgetbhaa) = IRRs were reported in 33% (n=17, one grade 4) of patients given 1 dose of dexamethasone (8 mg) as premedication (n=51); these IRRs were most frequently tachycardia and chills, with no anaphylactic reactions reported. Following the data cut-off, there was a second grade 4 IRR, and the prophylactic regimen was increased with two additional doses of dexamethasone on the day prior to the PVEK dose. The IRR rate has dropped to 8% (3 of 38), with no grade 3+; all were grades 1-2 that resolved with limited intervention (P<0.01) kqnwgwsrph (cogjaxbkwq )	-	01 Oct 2022
NCT03386513 (CADENZA, Corporate Publications) Manual	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm	10	pivekimab (de novo patients)	glnvkrpeoc(prxcvqkzxd) = tygjyojfce rlzouhtypi (gdwwywafqb )	Positive	31 Aug 2022
NCT03386513 (CADENZA, Corporate Publications) Manual	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm	10	pivekimab (PCHM patients)	rtytuufntf(sxotxzpufa) = ullzlctguh kqfcmxzqtc (lrqtieqjlz )	Positive	31 Aug 2022
NCT04086264 (AML-367, SOHO2020)	Phase 1/2	Acute Myeloid Leukemia CD123	-	IMGN632	htfogkugxb(xyyuunuxkq) = vgttumaxmp tvegixsdmn (xjjkoawpxg ) View more	-	01 Sep 2020
NCT04086264 (AML-367, SOHO2020)	Phase 1/2	Acute Myeloid Leukemia CD123	-	Azacitidine	htfogkugxb(xyyuunuxkq) = vmrogixdat tvegixsdmn (xjjkoawpxg ) View more	-	01 Sep 2020
NCT03386513 (EHA2019)	Phase 1	Acute Myeloid Leukemia	179	IMGN632 plus venetoclax	eatucsnbgh(wnhtzvvvjb) = dqikoelfvu wmabfmvzhl (wvjhpelptg ) View more	-	14 Jun 2019

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