On November 3, 2025 Servier reported longer-term data from the Phase 3 INDIGO trial evaluating VORANIGO (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma following surgical intervention and for whom chemoradiotherapy can be delayed were published in The Lancet Oncology. The analysis reports an additional six months of placebo-controlled, double-blind data collected between the second interim analysis data cutoff on September 6, 2022, and trial unblinding on March 7, 2023. These positive results confirm and strengthen the previous findings from the INDIGO pivotal trial.

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"These longer-term results from the INDIGO trial build upon VORANIGO’s previously demonstrated clinical benefits and demonstrate reductions in tumor volume and seizure frequency in patients with IDH-mutated gliomas," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "One year after the FDA approval of VORANIGO, we’re immensely proud to have delivered this first-of-its-kind targeted therapy to thousands of patients living with IDH-mutated glioma, offering them clinically meaningful and durable treatment benefits supported by more than a decade of research."

As of data cutoff on March 7, 2023, median follow-up was 20.1 months. Key findings from the newly published analysis include:

Median progression-free survival (PFS) improved with VORANIGO (not estimable [NE] [95% CI, 22.1-NE]) compared to placebo (11.4 [95% CI, 11.1-13.9] months), with the hazard ratio (HR) continuing to favor VORANIGO (HR, 0.35 [95% CI, 0.25-0.49]; p<0.0001*). PFS was the primary endpoint of the trial.
Imaging-based disease progression per blinded independent review committee (BIRC) occurred in 32% of patients receiving VORANIGO versus 64% receiving placebo.
Prespecified subgroup analyses continued to show that PFS per BIRC was consistent across all subgroups, favoring VORANIGO over placebo.
Median time to next intervention (TTNI) also improved with VORANIGO versus placebo (NE versus 20.1 months, respectively; HR, 0.25 [95% CI, 0.16-0.40]; p<0.0001*), reflecting durability of disease management. TTNI was a key secondary endpoint of the trial.
Treatment with VORANIGO reduced tumor growth rate and seizure frequency over placebo with no observed negative effects on health-related quality of life (HRQoL) or neurocognition.
An exploratory analysis of patients experiencing one or more seizures showed that rates of on-treatment seizures per person-year were lower in patients receiving VORANIGO (18.2 seizures per person-year [95% CI, 8.4-39.5]) than in those receiving placebo (51.2 seizures per person-year [95% CI, 22.9-114.8]; p=0.026).
The safety profile of VORANIGO was consistent with previously reported data. The most commonly reported Grade ≥3 or worse treatment-emergent adverse events (TEAEs) were increased alanine aminotransferase (10%), increased aspartate aminotransferase (5%), seizures (4%) and increased gamma-glutamyltransferase (3%). No new safety signals were detected and fewer than 5% of patients discontinued treatment due to an adverse event. There were no treatment-related deaths.
*The reported P-values are nominal and were not prespecified or adjusted for multiplicity; therefore, the results should be interpreted with caution.

"For decades, patients with Grade 2 IDH-mutated gliomas had limited treatment options. While surgery was often the first line treatment option for glioma, total resection was rarely achievable because tumors continue to grow and infiltrate the brain even after surgery," said Timothy Cloughesy, M.D., David Geffen School of Medicine, Department of Neurology, University of California, Los Angeles, investigator for the INDIGO trial. "The longer-term data from the INDIGO trial demonstrate that targeted IDH inhibition can fundamentally alter the growth trajectory of certain gliomas, leading to gradual tumor shrinkage."

These data were previously presented at the 2024 Society for Neuro-Oncology Annual Meeting (SNO). VORANIGO was approved by the U.S. Food and Drug Administration (FDA) in August 2024 after receiving Fast Track Designation and became the first and only FDA-approved targeted treatment for Grade 2 IDH-mutant glioma.

The Phase 3 INDIGO trial is ongoing. Servier plans to present longer-term follow-up results from the largest dataset to date in IDH-mutant glioma, with remarkable overall response rates and PFS outcomes not previously reported in a cohort this size.

(Press release, Servier, NOV 3, 2025, View Source [SID1234659299])

On November 3, 2025 Sumitomo Pharma America, Inc. (SMPA) reported three oral presentations and one poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place in Orlando, Florida, from December 6-9, 2025. The presentations will include new clinical data supporting enzomenib, an investigational, oral small molecule menin inhibitor being researched as a monotherapy and in combination with venetoclax and azacitidine (VEN/AZA) for relapsed or refractory acute leukemia, and nuvisertib, an oral investigational highly selective small molecule PIM1 kinase inhibitor being evaluated as a monotherapy and in combination with momelotinib (MMB) for the treatment of relapsed or refractory myelofibrosis (MF).

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Updated clinical data from the ongoing Phase 1/2 study of enzomenib continue to show promising clinical activity across a wide range of potentially therapeutic doses in patients with relapsed or refractory acute leukemia with KMT2A-rearranged (KMT2Ar), NPM1-mutated (NPM1m), and other HOXA9/MEIS1-driven leukemia subtypes. Enzomenib is designed to target the menin and mixed-lineage leukemia (MLL) protein interaction, a key interaction for acute leukemia and cell growth in a variety of cancers. In this dose-escalation study of enzomenib monotherapy, enzomenib was escalated from 40 mg twice a day (BID) to 400 mg BID with no dose-limiting toxicities (DLTs) in 116 patients with sustained complete remission (CR) and complete remission with partial hematologic recovery (CRh) seen at doses of 200, 300 and 400 mg BID. Given the wide therapeutic window of enzomenib, these findings suggest that dosing may be tailored to the specific biology of different leukemia subtypes for potential optimal therapeutic effect.

Additionally, preliminary findings from a Phase 1 study of enzomenib in combination with VEN/AZA in patients with relapsed or refractory AML with KMT2Ar or NPM1m subtypes show enzomenib with VEN/AZA to be well-tolerated to up to 300 mg BID with no DLTs and no evidence of significant drug-drug interaction between enzomenib and VEN. Promising early clinical activity, particularly in patients without prior VEN or menin exposure, was also observed.

New clinical data from the Phase 1/2 study evaluating the safety and efficacy of nuvisertib in combination with MMB demonstrate early clinical activity and show that the treatment combination was well-tolerated supporting further development in patients with MF. Lastly, findings from the ongoing Phase 1/2 study of nuvisertib continue to support that nuvisertib monotherapy was well-tolerated with no DLTs and notable modulation of cytokine profiles demonstrating a strong correlation with clinical responses.

"Patients living with relapsed/refractory AML or MF desperately need effective therapies to overcome the poor prognoses typically associated with these cancers. The clinical data are highly compelling, especially for patients with particularly challenging forms of acute leukemia including those with KMT2A-rearranged and NPM1-mutated subtypes," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. "Based on this progress, we look forward to sharing more comprehensive data further supporting the development of enzomenib and nuvisertib at the upcoming meeting in December and remain committed to advancing both of these programs."

Abstract Title

Detail

Lead Author

Nuvisertib, an oral investigational selective PIM1 kinase inhibitor, showed clinical responses strongly correlating with cytokine modulation in patients with relapsed/refractory myelofibrosis in the ongoing global phase I/II study

Poster Presentation

Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I

Saturday, December 6.

5:30 – 7:30 p.m. EST

Presentation Time and Location: 5:30 p.m. EST

West Halls B3-B4 (Orange County Convention Center)

Lindsay A.M. Rein, M.D.

Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis

Oral Podium Presentation

Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Between a Rock and a Ropeg – Innovative Therapies for MPNs

Sunday, December 7.

9:30 – 11 a.m. EST

Presentation Time and Location: 9:45 a.m. EST

W414AB (Orange County Convention Center)

John Mascarenhas, M.D.

Monotherapy Update from Phase 1 Portion in Phase1/2 trial of the Menin-MLL Inhibitor Enzomenib (DSP-5336) in Patients with Relapsed or Refractory Acute Leukemia

Oral Podium Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin inhibitors and FLT3 inhibitors in AML

Monday, December 8.

10:30 a.m. – noon EST

Presentation Time and Location: 10:30 a.m. EST

Chapin Theater (320) (Orange County Convention Center)

Naval G. Daver, M.D.

Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib

(DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute

Myeloid Leukemia

Oral Podium Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin inhibitors and FLT3 inhibitors in AML

Monday, December 8.

10:30 a.m. – noon EST

Presentation Time and Location: 11 a.m. EST

Chapin Theater (320) (Orange County Convention Center)

Justin M. Watts, M.D.

About Enzomenib
Enzomenib is an investigational, oral, small molecule inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein which plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.1,2 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A (MLL) rearrangements or NPM1 mutations.1,3 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1, and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with MLL rearrangements and NPM1 mutation.4,5 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose escalation/dose expansion study in patients with relapsed or refractory acute leukemia (NCT04988555). The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with MLLr or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with MLLr or NPM1m in September 2024.

About Nuvisertib (TP-3654)
Nuvisertib (TP-3654) is an oral investigational selective inhibitor of PIM1 kinase, which has shown potential antitumor and antifibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.6,7 Nuvisertib was observed to inhibit proliferation and increase apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2 V617F mutation.7 Nuvisertib alone and in combination with ruxolitinib showed white blood cell and neutrophil count normalization, and also reduced spleen size and bone marrow fibrosis in JAK2 V617F and MPLW515L murine models of myelofibrosis.6 The safety and efficacy of nuvisertib is currently being clinically evaluated in a Phase 1/2 study in patients with intermediate and high-risk myelofibrosis (NCT04176198). The FDA granted Orphan Drug Designation to nuvisertib for the indication of myelofibrosis in May 2022. The Japan Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in November 2024. The FDA granted Fast Track Designation to nuvisertib for the indication of myelofibrosis in June 2025, and the European Medicines Agency granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in July 2025.

(Press release, Sumitomo Pharmaceuticals, NOV 3, 2025, View Source [SID1234659298])

On November 3, 2025 Pierre Fabre Pharmaceuticals Inc. (PFP) reported the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc. (Nasdaq: ATRA) with PFP now accountable for all aspects of the submission. Atara will continue to observe the regulatory process and provide support to PFP as needed. The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026. If approved, the tabelecleucel will be indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy.

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Atara resubmitted the tabelecleucel BLA on July 11, 2025 of this year, in collaboration with PFP, and the FDA accepted the tabelecleucel BLA with Priority Review on July 23. With completion of the transfer of the BLA, Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development regulatory, commercial and manufacturing activities for tabelecleucel worldwide. The innovative cell therapy is manufactured by PFP in the US for global clinical development and commercial access.

"Transfer of the BLA represents another critical milestone in our efforts to bring this innovative cell therapy to EBV+ PTLD patients in the US who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment," said Adriana Herrera, chief executive officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. "We look forward to our continued engagement with the FDA in completing the review of tabelecleucel BLA as we seek to transform outcomes for this ultra-rare, acute, and potentially deadly blood malignancy that occurs after transplantation."

Tabelecleucel is an investigational, allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT.

About EBV+PTLD
EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.

About Tabelecleucel
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to selectively target and eliminate EBV-infected cells. Unlike autologous CAR-T therapies, allogeneic T-cells are derived from third-party donors and are not genetically modified. Immune cells are collected from the blood of healthy donors and exposed to Epstein-Barr virus antigens to enrich for T cells that recognize EBV. These EBV T cells are expanded, characterized, kept alive, and stored for future use in treating patients.

(Press release, Pierre Fabre, NOV 3, 2025, View Source;302601901.html [SID1234659297])

On November 3, 2025 Recordati Rare Diseases Inc. reported the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which takes place December 6-9, 2025, in Orlando, Fla. In a series of nine poster presentations, Recordati researchers and independent investigators will present research detailing advances in Castleman disease (CD), cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS), and immune-related complications of CAR T-cell therapy. Highlights include a report on the development of an artificial intelligence (AI) model that evaluates CD tissue samples; an analysis of the morbidity burden and healthcare costs among patients with idiopathic multicentric Castleman disease (iMCD); the first real-world evaluation of sutimlimab in the treatment of patients with CAD or CAS; and a prospective evaluation of siltuximab in the prevention or treatment of cytokine release syndrome (CRS) after CAR T-cell therapy.

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"We are particularly excited about the long-term safety data for sutimlimab in cold agglutinin disease and the growing body of research investigating the use of siltuximab in Castleman disease," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "Also notable is the poster describing an innovative, AI-based approach to lymph node analysis, which could represent a meaningful step toward earlier and more consistent diagnosis of Castleman disease, one of the most difficult hematologic conditions to diagnose accurately. Altogether, the datasets presented at ASH (Free ASH Whitepaper) 2025 reflect Recordati’s ongoing commitment to advancing care for people living with rare hematologic disorders."

"The ASH (Free ASH Whitepaper) Annual Meeting is an important opportunity to showcase research advances in hematologic diseases, and we are pleased that the meeting organizers have accepted nine abstracts related to our therapies," said Mohamed Ladha, President and General Manager at Recordati Rare Diseases North America. "Together with our independent research partners, Recordati is at the forefront of advancing potential therapeutic solutions for people living with devastating conditions such as Castleman disease. We look forward to these data sparking further dialogue and collaboration as we continue in our efforts to improve patients’ lives."

The ASH (Free ASH Whitepaper) 2025 Annual Meeting will feature the following poster presentations:

Castleman Disease

Poster number: 2606
Title: Retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls (BURDEN-iMCD)
Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic

Poster number: 3001
Title: Comprehensive analysis of subtype-specific outcomes and management in Castleman disease: a 20-year cohort study
Presenting author: Yoshito Nishimura, MD, PhD, MPH, Mayo Clinic

Poster number: 3002
Title: Automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model
Presenting author: Muir Morrison, PhD, University of Utah

Poster number: 3009
Title: Pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab
Presenting author: Bridget Austin, MS, Perelman School of Medicine, University of Pennsylvania, Center for Cytokine Storm Treatment & Laboratory

Poster number: 3006
Title: Epidemiology and clinical characteristics of idiopathic multicentric Castleman disease in Spain (ARCANA study): Prevalence cohort
Presenting author: José-Tomás Navarro, MD, PhD, Catalan Institute of Oncology, Josep Carreras Leukaemia Research Institute

Poster number: 4788
Title: Siltuximab-mediated suppression of CRP is associated with clinical response in idiopathic multicentric Castleman disease
Presenting author: Jean-Francois Rossi, MD, PhD, Université de Montpellier

Cold Agglutinin Disease (CAD)

Poster number: 6242
Title: Real-world safety of sutimlimab in patients with CAD/CAS: a multinational, multicenter, observational, prospective cohort study
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

CAR T-Cell Therapy Toxicity (including in B-Cell Lymphoma)*

Poster number: 2385
Title: Safety and immunomodulatory effects of siltuximab prophylaxis prior to standard of care CD19 directed chimeric antigen receptor T-cell (CD19.CART) therapy for B-cell lymphomas: final Phase I trial results
Presenting author: Nathan Denlinger, DO, MS, The Ohio State University Wexner Medical Center, James Comprehensive Cancer Center

Poster number: 5919
Title: Siltuximab versus tocilizumab for the management of CAR T-cell associated cytokine release syndrome
Presenting author: Mayur Narkhede, MD, University of Alabama at Birmingham

*These studies were conducted as investigator-sponsored studies without research involvement by Recordati.

About Idiopathic Multicentric Castleman Disease (iMCD)
Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a central pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats.

About Cold Agglutinin Disease (CAD)
Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients’ quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30.

(Press release, Recordati, NOV 3, 2025, View Source [SID1234659296])

On November 3, 2025 AAVivo, Inc., a pioneering biotechnology company developing novel, precision targeted biotherapeutics to enable in vivo generation of CAR-T cells, reported a presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025, which is being held November 5-9, in National Harbor, MD.

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AAVivo will present a poster titled, "In Vivo Generation of CD19-Specific CAR-T Cells Using a Novel AAV Gene Therapy Platform to Treat B Cell Malignancies". The poster describes the Company’s lead candidate, AVO-100, a gene therapy that is designed using adeno-associated viruses (AAV) with capsids containing T cell-targeting (TCeT) moieties to produce CD19-specific CAR-T cells in patients. Preclinical data to date suggest that AVO-100 can be used to generate CD19-specific T cells from non-activated T cells in human PBMCs both in vitro and in vivo and the CAR-T cells can control the growth of Raji lymphoma in vitro and in NSG mice.

"We are pleased that a poster highlighting the potential of our iAAV platform to rapidly enable in vivo generation of CAR-T cells was accepted for presentation at SITC (Free SITC Whitepaper) 2025," said Haifeng Chen, Ph.D. Chief Technology Officer & Founder of AAVivo. "Having this research accepted for presentation at SITC (Free SITC Whitepaper), one of the preeminent oncology conferences, showcases the breadth of AAVivo’s patented technologies and the potential of AVO-100, our lead program targeting B-cell malignancies."

Details of the poster being presented at SITC (Free SITC Whitepaper) 2025 are as follows:

Abstract Number: 1001
Abstract Title: In Vivo Generation of CD19-Specific CAR-T Cells Using a Novel AAV Gene Therapy Platform to Treat B Cell Malignancies
Presenting Author: Haifeng Chen, Ph.D. Chief Technology Officer & Founder, AAVivo, Inc.
Session Date: Friday, Nov. 7

(Press release, AAVivo, NOV 3, 2025, View Source [SID1234659295])