On December 8, 2025 Pillar Biosciences and AstraZeneca reported an expansion of their existing laboratory access program for NGS-based kitted liquid biopsy tumor profiling to include China.

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This expanded collaboration aims to deliver rapid, cost-effective, and clinically actionable genomic insights through liquid biopsy testing. By increasing the local availability of plasma-based tumor profiling at leading clinical laboratories in China, the partnership seeks to accelerate diagnostic turnaround times and improve access to precision oncology solutions.

China faces one of the world’s highest cancer burdens, accounting for approximately 24% of new global cancer cases and 30% of cancer-related deaths, according to the World Health Organization’s GLOBOCAN 2022 report. Lung, colorectal, and liver cancers remain among the most prevalent, and access to early detection and molecular diagnostics continues to be a significant healthcare challenge. By expanding localized liquid biopsy testing, this collaboration supports China’s ongoing initiatives to enhance early cancer detection, precision diagnostics, and equitable access to targeted therapies.

As part of the initiative, AstraZeneca, Pillar Biosciences, and Shanghai Zhengu Biological Technology Co., Ltd. (Zhengu) will collaborate to support assay validation in local hospital laboratories and facilitate the implementation of Pillar’s liquid biopsy panels to enable localized tumor profiling.

"Expanding access to decentralized, high-quality molecular testing is critical to improving outcomes for cancer patients," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "By enabling local laboratories to perform in-house next-generation sequencing, we can reduce turnaround times, lower costs, and ensure that oncologists have faster access to actionable insights that guide personalized treatment decisions."

(Press release, Pillar Biosciences, DEC 8, 2025, View Source [SID1234661284])

On December 8, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported new data from the company-sponsored ASTX030-01 and ASTX727-03 studies evaluating all-oral regimens of azacitidine and cedazuridine or decitabine and cedazuridine in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML). Data from the studies will be shared in two oral presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held on December 6-9, 2025, in Orlando, Florida. Collectively, new data from 15 company-sponsored and company-funded externally led studies will be presented, demonstrating an increasing commitment to understanding novel oral regimens in hematology.

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An oral presentation will highlight results from the Phase 2 ASTX030-01 trial, a multicenter, randomized, open-label, crossover trial comparing the all-oral combination of azacitidine and cedazuridine to subcutaneous azacitidine among patients with MDS, CMML or AML.

A second oral presentation will share findings from the Phase 2 ASTX727-03 trial of low-dose oral decitabine and cedazuridine versus an attenuated course of standard-dose decitabine in patients with lower-risk MDS.

Azacitidine and decitabine belong to a class of antineoplastic agents known as DNA methyltransferase inhibitors (DMTIs). Each is paired with cedazuridine, a cytidine deaminase inhibitor, to help the agent stay active in the body without degrading.

"We are pleased to present positive data suggesting that oral azacitidine and cedazuridine in patients with MDS, CMML and AML, and decitabine and cedazuridine in patients with lower-risk MDS may be comparable in safety and effectiveness to frequently used parenteral therapies for those populations," said Harold Keer, MD, PhD, Chief Medical Officer of Taiho Oncology. "While standard hypomethylating agents are administered via infusion in the clinic, these novel treatments are designed to be taken orally at home, potentially improving flexibility and lowering the treatment burden for patients."

Authors will report results from the ASTX030-01 study of oral azacitidine and cedazuridine versus subcutaneous azacitidine in patients with MDS, CMML or AML: 1

Investigator Summary of Results

As of the May 2025 data cutoff, 30 patients received treatment, including 22 individuals with MDS, five with CMML, two with AML and one with MDS/myeloproliferative neoplasms (MPN); all were eligible for single-agent azacitidine. The patients were randomly assigned in a 1:1 ratio to receive ongoing cycles of therapy. One group received ASTX030 except during cycle 2, when subcutaneous azacitidine was administered, while the other group received subcutaneous azacitidine in cycle 1 followed by ASTX030 in all subsequent cycles.

As of the data cutoff, ASTX030 Phase 2 results demonstrated the following:

The primary endpoint was the geometric mean ratio (GMR) of azacitidine total cycle AUC 0–24 exposures after oral ASTX030 over subcutaneous azacitidine, and the result for that endpoint was 0.913 (90% confidence interval [CI]: 0.78, 1.07).
In patients with MDS (n=22), the complete response (CR) rate was 22.7% and overall response rate was 50%.
Among patients who were dependent on red blood cell (RBC) transfusions at baseline (n=13), 30.8% achieved independence from RBC transfusions for 56 days or more.
When stratifying by body surface area (BSA), patients with intermediate BSA had a GMR of 0.980 (90% CI: 0.85, 1.13), whereas the subset of patients with a high BSA had a GMR of 0.700 (90% CI: 0.55, 0.89) and further simulations suggested that BSA-adjusted dosing will help ensure the PK exposure of the oral combination approximates that of subcutaneous azacitidine.

Summary of Preliminary Safety and Tolerability

Adverse events (AEs) were reported in 100% of trial participants, with 83.3% of those AEs classified as grade 3 or higher.
The most common treatment-emergent adverse events (TEAEs), the majority of which were grade 1 or 2, were nausea (70%), constipation (66.7%) and fatigue (60%).
The most common TEAEs of grade 3 or higher were thrombocytopenia (43.3%), neutropenia (33.3%) and anemia (30%).
AEs leading to treatment withdrawal or dose reduction occurred in two (6.7%) and four (13.3%) patients, respectively, and there were 12 (40%) AEs that led to treatment interruption or delay.
Authors will report results from the ASTX727-03 study of low-dose oral decitabine and cedazuridine versus standard-dose decitabine and cedazuridine in patients with lower-risk MDS2

Investigator Summary of Results

As of the October 2024 data cutoff, 81 patients with low-risk or intermediate-1 MDS and either one or more cytopenias or dependence on red blood cell transfusions were treated in the Phase 2 ASTX727-03 study, comparing a low-dose (LD), all-oral regimen of decitabine and cedazuridine with an attenuated course of standard dose (SD) decitabine and cedazuridine (DEC-C). Patients received 10 mg of oral decitabine and 100 mg cedazuridine for five days or 35 mg decitabine and 100 mg cedazuridine for three days. Patients were treated a median of 8.8 months, with patients in the LD arm receiving a median of 10 cycles and those in the SD arm receiving a median of 9 cycles.

As of the data cutoff, ASTX727-03 Phase 2 results demonstrated the following:

Median overall survival (OS) was 23.9 months in the LD arm versus 26.0 months in the SD arm.
Median leukemia-free survival (LFS) was 23.8 months in the LD arm versus 25.7 months in the SD arm.
Hematologic improvement per International Working Group 2006 criteria was achieved in 27.5% LD patients and 26.8% SD patients.
Among patients dependent on RBC transfusions, 52.4% of LD patients and 37.5% SD patients achieved RBC transfusion independence.
Pharmacokinetic exposure AUC in the LD arm was approximately half that in the SD arm.
Summary of Preliminary Safety and Tolerability

Delayed cycles occurred in 72.5% of patients in the LD arm versus 82.9% of those in the SD arm. Dose reductions occurred in 40% of patients in the LD cohort versus 46.3% of patients in the SD group.
Both treatment regimens caused a decrease in blood counts. Neutropenia was more pronounced in early cycles and was more severe in the SD arm. Blood counts across all lineages remained stable or improved through 12 or more cycles with the LD arm, suggesting a more favorable safety and tolerability profile.
AEs of grade 3 or higher occurred in 85% of patients in the LD arm and 90.2% of patients in the SD arm. Treatment discontinuation due to AEs occurred in 2.5% of patients in the LD arm versus 17.1% of patients in the SD arm.
The most commonly reported treatment-emergent AEs were anemia (42.5% LD versus 39% SD), fatigue (32.5% LD versus 43.9% SD) and thrombocytopenia (37.5% LD versus 39% SD).
3 deaths occurred in the trial: 2 in the LD arm, both unrelated to study treatment, and 1 in the SD arm due to pseudomonal bacteremia in cycle 1, which was treatment-related.

(Press release, Taiho, DEC 8, 2025, View Source [SID1234661283])

On December 8, 2025 Sumitomo Pharma America, Inc. (SMPA) reported new clinical data supporting further development of enzomenib, an investigational, oral selective menin inhibitor being researched for the treatment of relapsed or refractory acute leukemia, and nuvisertib, an oral investigational highly selective small molecule PIM1 kinase inhibitor, being researched for the treatment of relapsed or refractory myelofibrosis (MF), at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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Updated Data Shared with the Use of Enzomenib in Acute Myeloid Leukemia
Updated preliminary data were presented from the ongoing Phase 1/2 study of enzomenib monotherapy, which as of October 4, 2025, included 116 total patients with acute leukemia, most of whom (93.1%, 108/116) had acute myeloid leukemia (AML) with a median of two prior regimens. Genomic abnormalities of leukemia subtypes including KMT2A rearrangement (KMT2Ar) were documented in 61 patients (52.6%), NPM1 mutation (NPM1m) in 34 patients (29.3%), and other HOXA9/MEIS1-driven abnormalities in 21 patients (17.7%).

Enzomenib was escalated from 40 mg twice a day (BID) to 400 mg BID with no dose-limiting toxicities (DLTs). Treatment-related adverse events (TRAEs) observed in at least 10% of patients were nausea (16.4%), and vomiting (11.2%). Differentiation syndrome (DS) was reported in 12.9% of patients and did not result in patient deaths, study discontinuations, or dose reductions of enzomenib. No treatment-related deaths were observed in the study. Dose-dependent increases in exposure were observed, particularly at doses greater than 140 mg BID. Little to no drug accumulation was observed, and CYP3A4 inhibitor azoles did not have a significant impact on exposure.

In patients with KMT2Ar, dose optimization of 200, 300, and 400 mg BID is complete, and the RP2D has been determined as 300 mg BID. At RP2D, in patients with KMT2Ar who had not received prior treatment with a menin inhibitor (n = 15), the objective response rate (ORR) was 73.3% and CR+CRh was 40%. Across the optimization dose levels, the duration of CR+CRh (n = 11) was 12.5 months and in all optimization patients (n = 39) median overall survival (mOS) was 11.8 months.

For patients with NPM1m AML, dose optimization is ongoing at 200, 300, and 400 mg BID with a focus on 200 and 300 mg BID in patients who have not received a prior menin inhibitor. In the NPM1m dose optimization population (n=25, pts who received ≥ 200 mg BID), ORR is 52% and CR+CR is 44% with a duration of CR+CRh of 5.7 months. The mOS was 8.5 months.

"Despite improved understanding of the genetic factors of certain high-risk subtypes in acute leukemias, poor prognosis for patients remains a significant unmet need," said Naval G. Daver, M.D., professor and director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center in Houston. "The data from this ongoing Phase 1/2 study continue to show that enzomenib exhibits promising clinical activity, with encouraging overall and complete response rates, duration of response, and no significant drug interactions with azoles in patients with relapsed or refractory KMT2Ar or NPM1m AML. As an intentionally designed oral therapy to inhibit menin and KMT2A protein interaction, these encouraging clinical results combined with a promising safety profile support the potential of enzomenib as a therapeutic option for relapsed or refractory acute leukemia patients with KMT2A-rearranged or NPM1-mutated subtypes of the disease."

Also presented were preliminary results of a Phase 1 study of enzomenib at dose levels of 140 mg, 200 mg, and 300 mg BID in combination with azacitidine and venetoclax (VEN/AZA) in patients with relapsed or refractory AML with KMT2Ar or NPM1m. VEN was administered on days 1-14 of a 28-day study cycle, AZA on days 1-7, and enzomenib was administered on days 1-28 with and without azole antifungal agents.

A total of 40 patients were enrolled, of which 18 had KMT2Ar (45%) and 22 (55%) had NPM1m. The median number of prior regimens was 2, with 15 patients having received prior venetoclax (37.5%) and 11 patients (27.5%) a prior menin inhibitor.

There were no DLTs observed in the 40 patients enrolled. Hematologic TRAEs related to any regimen component observed in at least 15% of patients included thrombocytopenia (45%), leukopenia (35%), neutropenia (30%), anemia (22.2%), and lymphopenia (15%). Non-hematologic TRAEs were nausea (25%), diarrhea (20%), and AST increased and constipation (15% each). Any-cause QT interval prolongation was reported in 4 patients (10%) with no grade 3 or higher events; no cases were considered related to enzomenib. There were also 4 events of non-serious DS with 0 events grade 3 or higher. Pharmacokinetic data indicated that there were no significant drug-drug interactions between enzomenib and VEN.

As of the clinical data cutoff on October 4, 2025, clinical activity data is available for 26 of the 40 total patients as 11 patients were still in Cycle 1 (n = 9) or Cycle 2 (n = 2), and 3 patients had cutaneous leukemia without measurable disease in the bone marrow (bone marrow blasts <5%).

Promising preliminary clinical activity has been observed, particularly in patients without prior VEN or menin inhibitor exposure (N=13). The ORR is 85% (11/13) and the composite complete remission (CRc) rate is 62% (8/13). Local MRD assessments were available in 9 patients and 7/9 (78%) achieved MRD negativity as of the cut-off.

These data support evaluating enzomenib with VEN/AZA in patients with newly diagnosed AML. Study arms are being added to investigate the combination regimen for patients with newly diagnosed disease. Enzomenib will be administered at 200 mg or 300 mg BID using VEN/AZA administered according to the FDA label. Enrollment of newly diagnosed patients with KMT2Ar or NPM1m AML will begin in early 2026.

Nuvisertib in Patients with Relapsed or Refractory (R/R) MF
For the first time, clinical data were presented from the ongoing global Phase 1/2 study evaluating the safety and efficacy of nuvisertib in combination with momelotinib (MMB) in 18 patients with R/R MF with anemia. All enrolled patients in the study had previously been treated with a JAK inhibitor, the current standard of care for patients with MF, and 61% of patients had high molecular risk mutation. Preliminary data showed that the treatment with nuvisertib and MMB combination appeared well tolerated, with early clinical activity observed, including ³50% total symptom score reduction (TSS50 response) in 58% of patients with an absolute reduction in all individual symptoms, a spleen volume reduction ³ 25% (SVR25 response) in 50% of patients, anemia improvement, and cytokine modulation in patients with relapsed or refractory MF with anemia. These preliminary data, collected as of October 15, 2025, support further development of nuvisertib in combination with MMB as a potential treatment option for patients with MF.

Additionally, data presented from the ongoing global Phase 1/2 study of nuvisertib in patients with relapsed or refractory MF (N=77) showed that nuvisertib monotherapy continued to be well tolerated with no DLTs and limited myelosuppression. The results showed that treatment with nuvisertib monotherapy led to SVR25 response in 20% of patients, TSS50 response in 45% of patients with absolute reduction in all individual symptoms. Data also showed that treatment with nuvisertib resulted in significant cytokine modulation over time, correlating with spleen and symptom responses and one-year overall survival rate of 81%.

"Patients living with myelofibrosis with anemia usually have a dismal prognosis, still continue to face limited treatment options," said John Mascarenhas, M.D., Director of the Center of Excellence for Blood Cancers and Myeloid Disorders, Icahn School of Medicine at Mount Sinai, New York. "The promising preliminary results from the combination of nuvisertib and momelotinib underscore the urgent need for new therapeutic approaches that may offer meaningful clinical benefits to a difficult to treat disease."

"We are excited to present the first-ever myelofibrosis data with a momelotinib-based combination, specifically nuvisertib in combination with momelotinib. The development of innovative therapies—both alone and in combination with other treatments—are critical for physicians and patients with blood cancers such as AML or MF who are in urgent need of new effective therapies," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. "Based on these updated preliminary data presented at ASH (Free ASH Whitepaper), which continue to show promising clinical activity and safety profiles for both enzomenib and nuvisertib, we remain committed to accelerate the clinical development in these programs with the ultimate goal of improving patient outcomes."

About Leukemia
Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells, in the bone marrow. Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.1 Approximately 30% of patients with AML have NPM1 mutations,2 and 5%-10% of patients with AML have KMT2A rearrangements.3

About Myelofibrosis (MF)
MF is a rare type of blood cancer that is characterized by the buildup of fibrous tissue in the bone marrow, which can affect the production of blood cells. This buildup is caused by dysregulation in the JAK signaling pathway. MF is a serious and rare disease with 0.7 new cases per 100,000 people worldwide each year.4

About Enzomenib (DSP-5336)
Enzomenib is an investigational, oral, small molecule inhibitor of the menin and Lysine (K)-specific methyltransferase 2A (KMT2A) 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.5,6 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.5,7 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 KMT2A rearrangements and NPM1 mutation.8,9 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). Additionally, the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study is now open for enrollment. 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 KMT2Ar 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 KMT2Ar or NPM1m in September 2024.

About Nuvisertib (TP-3654)
Nuvisertib 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.10,11 Nuvisertib was observed to inhibit proliferation and increase apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2 V617F mutation.10 Nuvisertib alone and in combination with ruxolitinib showed white blood cell and neutrophil count normalization and reduced spleen size and bone marrow fibrosis in JAK2 V617F and MPLW515L murine models of myelofibrosis.11 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 July 2025.

(Press release, Sumitomo Pharmaceuticals, DEC 8, 2025, View Source [SID1234661282])

On December 8, 2025 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported it will present updated meaningful median progression-free survival (mPFS) efficacy results from two combination regimens of the Phase 2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC with the goal of improving patient outcomes. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12.

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"The encouraging progression-free survival data increase our confidence in the role elacestrant could play as an endocrine therapy backbone in the combination setting," said Virginia Kaklamani, MD, DSc, Professor of Medicine in the Division of Hematology/Oncology at UT Health San Antonio, and Leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center. "The safety profile of elacestrant in combination with everolimus or abemaciclib is consistent with the known safety profiles of each drug. No new safety signals have been observed."

The ELEVATE data to be presented at SABCS demonstrate that elacestrant in combination with everolimus or with abemaciclib shows a consistent PFS benefit, irrespective of ESR1 mutation status in patients with ER+/HER2- mBC, who experience disease progression on endocrine therapy (ET), with or without prior exposure to CDK4/6 inhibitors. These updated results also show that the safety of the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy.

Phase 2 mPFS in months (95% CI) in all patients and subgroups

Patient Population

Elacestrant 345 mg QD

+ Everolimus 7.5mg QD

(n=50)

Elacestrant 345 mg QD

+ Abemaciclib 150 mg BID

(n=60)

All patients

8.3 [4.0 – 10.2]

14.3 [7.3-16.6]

Visceral disease

7.7 [3.8 – 9.4]

14.3 [7.4-16.6]

No prior fulvestrant

8.3 [4.2 – 12.9]

14.8 [8.7-NR]

No primary endocrine resistance

8.3 [4.0-12.9]

14.3 [7.3-16.6]

ESR1mut

8.7 [3.5 – 12.9]

*

ESR1wt

9.0 [4.2 – 12.7]

*

PIK3CAmut

8.3 [3.6 – 10.2]

*

PIK3CAwt

9.6 [5.6 – NR]

*

*Maturity not reached for PFS (95% CI) for genomic subgroups (ESR1 / PIK3CA) in the elacestrant + abemaciclib cohort.

"The extensive evidence for elacestrant spans the monotherapy setting in our pivotal EMERALD study, now backed by two recent real-world data publications[1], [2], and in its growing potential in combination regimens, as highlighted by the data presented at SABCS," said Elcin Barker Ergun, CEO of the Menarini Group. "We remain deeply committed to fully exploring elacestrant’s potential benefit across multiple ongoing trials in both early stage and metastatic breast cancer."

Additionally, other elacestrant updates will be presented at SABCS, investigating its potential across the spectrum of breast cancer:

Presentation Title: Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2-locally advanced or metastatic breast cancer (mBC): phase 2 results from ELEVATE, an open-label, umbrella study
Abstract Number: 1255
Presentation Date & Time: Thursday, December 11, 2025, 1:00 – 2:00 PM
Location: Hemisfair1-2
Presenting Author: Hope S. Rugo

Presentation Title: Elacestrant alone or in combination with triptorelin in premenopausal women with ER+/HER2-early breast cancer: primary analysis from the phase 2 SOLTI-2104-PremiÈRe trial
Abstract Number: 1123
Presentation Date & Time: Friday, December 12, 2025, 7:30 – 7:33 AM
Location: 301 ABC
Presenting Author: Mertixell Bellet

Presentation Title: ELEGANT: Elacestrant Versus Standard Endocrine Therapy (ET) in Women and Men With Node-positive, Estrogen Receptor-positive (ER+), HER2-negative (HER2-), Early Breast Cancer (eBC) With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-label Phase 3 Study.
Abstract Number: 1276
Presentation Date & Time: Thursday, December 11, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Aditya Bardia

Presentation Title: The ADELA study: A Double-blind, Placebo-controlled, Randomized Phase 3 Trial of Elacestrant (ELA)+ Everolimus (EVE) Versus ELA + Placebo (PBO) in ER+/HER2-Advanced Breast Cancer (aBC) Patients with ESR1-mutated Tumors Progressing on Endocrine Therapy (ET) + CDK4/6i
Abstract Number: 1141
Presentation Date & Time: Wednesday, December 10, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Antonio Llombart-Cussac

Presentation Title: ERADICATE: A phase Ib/II study of elacestrant plus trastuzumab deruxtecan in patients with CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer
Abstract Number: 2119
Presentation Date & Time: Friday, December 12, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Sara L. Sammons

Presentation Title: Hormonal receptor (HR)-positive HER2 negative breast cancer patients treated with preoperative Elacestrant and PULSAR adaptive radiotherapy: a phase II study (HELP Trial)
Abstract Number: 1071
Presentation Date & Time: Friday, December 12, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Luca Visani

About The Elacestrant Clinical Development Program

Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.

About ORSERDU (elacestrant)
U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Full prescribing information for the U.S. can be found at www.orserdu.com.

Important Safety Information
Warning and Precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose.

Adverse Reactions

Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea(13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).

Drug interactions

Concomitant use with CYP3A4 Inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.

Use in specific populations

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

(Press release, Menarini, DEC 8, 2025, View Source;metastatic-breast-cancer-mbc-at-the-2025-san-antonio-breast-cancer-symposium-302635656.html [SID1234661281])

On December 8, 2025 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported the publication of 12-month data from its Phase 1 study of patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis. The results from the first patients have been published in the respected peer-reviewed journal Gynecologic Oncology, under the title: "First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer."

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"We are proud to announce that our article has been published in Gynecologic Oncology. This recognition underscores the importance of our research and validates our ongoing efforts. As our phase 2 study progresses in patients with peritoneal metastasis from ovarian cancer, we remain fully committed to advancing new treatment options to address this urgent medical need," said Kari Myren, Chief Medical Officer at Oncoinvent.

The primary objectives of the phase 1 study were to evaluate the safety and tolerability of the alpha emitting therapy using 224Ra-labeled microparticles (Radspherin) and to determine the recommended dose for subsequent clinical development. Initial experiences indicate that all dose levels were well tolerated, no dose limiting toxicity was observed during dose escalation and the highest dose of 7 MBq was selected as the recommended dose for the expansion phase. Alongside the now published 12-month data, Oncoinvent has also released topline 24-month follow-up data for the phase 1 study in ovarian cancer patients.

A randomized controlled phase 2 study is ongoing to evaluate the efficacy and safety of Radspherin in patients with peritoneal metastasis from ovarian cancer. The primary aim is to compare progression-free survival (PFS) between two groups: those who receive Radspherin following complete surgical resection after pre-operative chemotherapy, and those treated with pre-operative chemotherapy and surgery alone. Further details can be found at clinicaltrials.gov.

(Press release, Oncoinvent, DEC 8, 2025, https://www.oncoinvent.com/press-release/oncoinvent-announces-publication-of-phase-1-study-results-for-radspherin-in-ovarian-cancer-in-gynecologic-oncology/ [SID1234661280])