On May 22, 2025 Cizzle Bio, Inc. reported the online publication of a new study abstract in conjunction with the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, projecting that its proprietary CIZ1B biomarker blood test for early-stage lung cancer could save the U.S. Medicare program up to $518 million annually (Press release, Cizzle Biotechnology, MAY 22, 2025, View Source [SID1234653330]). Co-authored by healthcare economist Jennifer Hinkel, M.Sc., the study models how integrating CIZ1B into lung cancer screening for high-risk Medicare populations could lower healthcare costs, reduce unnecessary procedures, and increase early-stage lung cancer detection.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Breakthrough Blood Test Expands Access and Reduces Costs

The CIZ1B biomarker test was developed from more than 30 years of research into the CIZ1 gene at the University of York, identifying the CIZ1B protein variant and its strong association with early-stage lung cancer. With 95% sensitivity for Stage I detection and Negative Predictive Value (NPV) at 96%, the test can detect lung cancer at its earliest, most treatable stage. Cizzle Bio is preparing for the commercial launch of CIZ1B in U.S. clinical environments in the coming months.

"Our economic models project that the CIZ1B test has the potential to be not only a clinical advance but a significant economic win for the healthcare system when implemented as part of lung cancer screening in high-risk, eligible Medicare populations," said Hinkel, a researcher in health economics and oncology outcomes. "By enabling earlier diagnoses and early intervention with less costly treatment, CIZ1B has the potential to make lung cancer screening more accurate, accessible, and sustainable, especially for Medicare patients."

Improves Lung Cancer Screening with Economic Impact

While low-dose CT (LDCT) is a clinically recommended method for lung cancer screening in high-risk individuals (such as those with a significant smoking history), only 4% to 6% of eligible Medicare beneficiaries undergo the procedure. The new study demonstrates that incorporating the CIZ1B biomarker blood test into lung cancer screening protocols could significantly reduce both the financial and clinical burdens currently associated with using LDCT alone.

The model hypothesized that introduction of a blood-based biomarker test such as CIZ1B would enable a 15% increase in lung cancer screening participation among Medicare-eligible high-risk individuals by reducing access barriers associated with LDCT screening including travel, availability, and radiation exposure concerns. The study modeled that this expanded access could identify many more lung cancer cases at an earlier stage, especially in underserved populations, than screening with LDCT alone at the current participation rates.

"Greater participation in screening programs is critical to shifting lung cancer diagnoses to earlier, more treatable stages," added Hinkel. "We have been challenged to move the needle on screening rates solely through education of clinicians and patients, and we know that barriers such as travel time to reach a CT scan appointment, or fear of extra radiation exposure and the risk of a biopsy procedure, can discourage patients from participating—even when there is so much benefit to catching cancer early. Because it is a simple blood test, CIZ1B testing can reach more patients where they are. Implementing cancer screening through a blood test like this can drive a real change toward better outcomes and lower costs in Medicare patients, which is very meaningful."

As a significant component of saving costs, the model projects that CIZ1B biomarker testing can reduce the number of unnecessary biopsies by improving screening specificity, or reducing false positives. LDCT often detects nodules that are visually suspicious, requiring a follow-up biopsy procedure, even though 96% of these procedures are on nodules that are found to be non-cancerous. Avoiding these invasive procedures not only reduces direct healthcare costs but also minimizes patient anxiety and complications.

"This publication is a significant milestone for Cizzle Bio," said Bill Behnke, founder and chief executive officer of Cizzle Bio. "Our mission is to make early lung cancer detection easier, more accurate, and more widely accessible. These findings strengthen the case for CIZ1B as a cornerstone of the future lung cancer screening paradigm."

The abstract is available online in conjunction with the ASCO (Free ASCO Whitepaper) 2025 Annual Meeting and can be accessed via www.asco.org/abstracts.

On May 22, 2025 Daiichi Sankyo (TSE: 4568) reported it will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program (#ASCO25) (Press release, Daiichi Sankyo, MAY 22, 2025, https://www.businesswire.com/news/home/20250522174780/en/Daiichi-Sankyo-Continues-to-Transform-Treatment-Landscape-for-Patients-with-Cancer-with-Practice-Changing-Data-at-ASCO [SID1234653346]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data at ASCO (Free ASCO Whitepaper) showcasing the company’s progress towards creating new standards of care for patients with cancer will include two late-breaking oral presentations. The first will feature results of the DESTINY-Breast09 phase 3 trial (LBA #1008) where ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab demonstrated superior progression-free survival compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. The second will highlight results of the DESTINY-Gastric04 phase 3 trial (LBA #4002) where ENHERTU demonstrated superior overall survival compared to ramucirumab and paclitaxel as a second-line treatment in patients with HER2 positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Data from DESTINY-Breast09 and DESTINY-Gastric04 will be featured in ASCO (Free ASCO Whitepaper) press briefings.

"This year’s ASCO (Free ASCO Whitepaper) marks the fourth in a row where potential practice-changing ENHERTU data will be showcased," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "With the results of DESTINY-Breast09 and DESTINY-Gastric04, we now have six breast and two gastric cancer randomized trials that have demonstrated significant survival improvements with ENHERTU. These data, along with other updates across our industry-leading oncology portfolio, underscore our commitment to pushing the boundaries of science to create new medicines or combination strategies that improve outcomes for patients with cancer."

Other ENHERTU data at ASCO (Free ASCO Whitepaper) will include an oral presentation featuring an exploratory circulating tumor DNA analysis of the DESTINY-Breast06 phase 3 trial (#1013) evaluating ENHERTU compared to physician’s choice of chemotherapy in hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) metastatic breast cancer. Updated results from the PRO-DUCE study (#1545) examining vital sign monitoring compared to usual care in patients with metastatic breast cancer receiving ENHERTU also will be highlighted as a poster presentation.

A trials-in-progress poster presentation will feature the DESTINY-Gastric05 phase 3 trial (TPS4207) evaluating ENHERTU in combination with a fluoropyrimidine-based chemotherapy and pembrolizumab compared to trastuzumab in combination with platinum-based chemotherapy and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer.

Progress in Lung Cancer Across Daiichi Sankyo’s DXd ADC Portfolio
Updated DATROWAY (datopotamab deruxtecan) combination data across three early-phase trials will be highlighted in patients with early or advanced non-small cell lung cancer (NSCLC).

Updated results from the TROPION-Lung02 phase 1b trial (#8501) evaluating DATROWAY plus pembrolizumab with or without platinum-based chemotherapy in patients with previously untreated advanced NSCLC without actionable genomic alterations will be featured as an oral presentation. This will include results from an exploratory analysis using quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform.

Poster sessions will highlight the first presentation of data of DATROWAY and rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, from the TROPION-Lung04 phase 1b trial (#8521) cohort evaluating the combination in patients without actionable genomic alterations who have advanced or metastatic NSCLC, and the final pathologic complete response and major pathologic response data from the NeoCOAST-2 phase 2 trial (#8046) evaluating DATROWAY with durvalumab, AstraZeneca’s anti-PD-L1 therapy, and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) NSCLC.

Additional lung cancer data at ASCO (Free ASCO Whitepaper) will include an oral presentation of the HERTHENA-Lung02 phase 3 trial (#8506) of patritumab deruxtecan (HER3-DXd) versus platinum doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression following the use of an EGFR tyrosine kinase inhibitor (TKI).

Trials-in-progress poster presentations in lung cancer across the DXd ADC portfolio will include the TROPION-Lung14 phase 3 trial (TPS8647) evaluating DATROWAY combined with osimertinib, AstraZeneca’s EGFR TKI, compared to osimertinib alone in the first-line setting of patients with locally advanced or metastatic EGFR-mutated NSCLC and a substudy of KEYMAKER-U01, a phase 1/2 trial (TPS8652), evaluating pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan with or without chemotherapy in patients with untreated advanced NSCLC.

Additional Data and Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio at ASCO (Free ASCO Whitepaper)
Oral presentations also will highlight initial results from the TUXEDO-3 phase 2 trial (#2005) evaluating patritumab deruxtecan in patients with metastatic breast cancer or advanced NSCLC and active brain metastases and in patients with leptomeningeal carcinomatosis/disease from advanced solid tumors, as well as results from a phase 1 trial (#10003) evaluating valemetostat, a dual EZH1 and EZH2 inhibitor, in pediatric patients with malignant solid tumors.

Additional DXd ADC trials-in-progress poster presentations include the REJOICE-PanTumor01 phase 2 trial (TPS3158) evaluating raludotatug deruxtecan (R-DXd) in patients with locally advanced or metastatic gynecologic or genitourinary cancers, IDeate-PanTumor02 phase 1b/2 trial (TPS3157) evaluating ifinatamab deruxtecan in patients with recurrent or metastatic solid tumors and a substudy of KEYMAKER-U06, a phase 1/2 trial (TPS4209) evaluating ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy in patients with advanced esophageal squamous cell carcinoma. Other trials-in-progress posters include the QuANTUM-Wild phase 3 trial (TPS6580) evaluating VANFLYTA (quizartinib) in combination with chemotherapy in patients with FLT3-ITD negative acute myeloid leukemia and a first-in-human phase 1 trial of DS-2243 (TPS2668), a potential first-in-class bispecific T-cell engager targeting HLA-A*02/NY-ESO in patients with advanced solid tumors.

Daiichi Sankyo will hold a virtual conference call for investors on Monday, June 2, 2025 from 6:00 to 7:15 pm CDT / Tuesday, June 3, 2025 from 8:00 to 9:15 am JST. Executives from Daiichi Sankyo will provide an overview of the ASCO (Free ASCO Whitepaper) research data and address questions.

Details of the two late-breaking ENHERTU oral presentations at ASCO (Free ASCO Whitepaper) 2025 include:

Presentation Title

Author

Abstract

Presentation (CDT)

LBAs

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) advanced/metastatic breast cancer: interim results from DESTINY-Breast09

S. Tolaney

LBA1008

Special LBA Session

Oral Presentation

Monday, June 2

7:30 – 8:00 am

Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary analysis of the randomized, phase 3 DESTINY-Gastric04 study

K. Shitara

LBA4002

Oral Presentation

Saturday, May 31

3:00 – 6:00 pm

Highlights of additional clinical data and trials-in-progress from Daiichi Sankyo’s oncology pipeline include:

Presentation Title

Author

Abstract

Presentation (CDT)

Breast

Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy in HER2 low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer in DESTINY-Breast06

R. Dent

1013

Oral Presentation​

Saturday, May 31​

1:15 – 4:15 pm

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2- breast cancer

J.

O’Shaughnessy

TPS629

Poster Session

Monday, June 2

9:00 am – 12:00 pm

Electronic patient-reported outcomes with vital sign monitoring versus usual care during trastuzumab deruxtecan treatment for metastatic breast cancer: updated results from the PRO-DUCE study

Y. Kikawa

1545

Poster Session

Sunday, June 1

9:00 am – 12:00 pm

Lung

TROPION-Lung02: datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer

B. Levy

8501

Oral Presentation

Sunday, June 1

8:00 – 11:00 am

Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated advanced non-small cell lung cancer after a third-generation EGFR TKI: the phase 3 HERTHENA-Lung02 study

T. Mok

8506

Oral Presentation

Sunday, June 1

8:00 – 11:00 am

First-line datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer: results from TROPION-Lung04 (cohort 5)

S. Waqar

8521

Poster Session

Saturday, May 31

1:30 – 4:30 pm

TROPION-Lung14: a phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line treatment for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer

S. Lu

TPS8647

Poster Session

Saturday, May 31

1:30 – 4:30 pm

Neoadjuvant durvalumab + chemotherapy + novel anticancer agents and adjuvant durvalumab ± novel agents in resectable non-small cell lung cancer: updated outcomes from NeoCOAST-2

T. Cascone

8046

Poster Session

Saturday, May 31

1:30 – 4:30 pm

KEYMAKER-U01 substudy 01A: phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non-small cell lung cancer

C. Aggarwal

TPS8652

Poster Session

Saturday, May 31 1:30 – 4:30 pm

Gastric

An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy ± pembrolizumab versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction cancer: DESTINY-Gastric05

K. Shitara

TPS4207

Poster Session

Saturday, May 31

9:00 am – 12:00 pm

Esophageal

KEYMAKER-U06 substudy 06E: phase 1/2 open-label, umbrella platform study of ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced esophageal squamous cell carcinoma

K. Kato

TPS4209

Poster Session

Saturday, May 31

9:00 am – 12:00 pm

AML

QuANTUM-Wild: a phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3-ITD negative acute myeloid leukemia

P. Montesinos

TPS6580

Poster Session

Sunday, June 1

9:00 am – 12:00 pm

Pan-Tumor

Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non-small cell lung cancers, and leptomeningeal disease from advanced solid tumors: results from the TUXEDO-3 phase 2 trial

M. Preusser

2005

Oral Presentation

Friday, May 30

2:45 – 5:45 pm

IDeate-PanTumor02: a phase 1b/2 study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with recurrent or metastatic solid tumors

T. Kogawa

TPS3157

Poster Session

Monday, June 2

1:30 – 4:30 pm

REJOICE- PanTumor01: a phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors

L. Albiges

TPS3158

Poster Session

Monday, June 2

1:30 – 4:30 pm

A phase 1, first-in-human study of DS-2243, an HLA-A*02/NY-ESO directed bispecific T‑cell engager, in patients with advanced solid tumors

S. D’Angelo

TPS2668

Poster Session

Monday, June 2

1:30 – 4:30 pm

Pediatric

Safety and efficacy of the EZH1/2 inhibitor valemetostat tosylate (DS-3201b) in pediatric patients with malignant solid tumors (NCCH1904): a multicenter phase 1 trial

A. Arakawa

10003

Oral Presentation

Saturday, May 31

3:00 – 6:00 pm

On May 22, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill (Press release, Exact Sciences, MAY 22, 2025, View Source [SID1234653300]). Presentations include new data on the Oncodetect molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score test, and the Cologuard test that underscore Exact Sciences’ expanding portfolio and commitment to advancing care through scientific excellence.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The data Exact Sciences will present at ASCO (Free ASCO Whitepaper) 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline," said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. "From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision."

Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening.

New Data and Continuous Evidence Generation Underscore the Oncodetect Test’s Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings.

New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences’ MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection.

Exact Sciences abstracts at ASCO (Free ASCO Whitepaper) include:

Precision Oncology

The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study
Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT
Abstract number: 3590
Molecular Residual Disease (MRD) in Solid Tumors
Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT
Abstract number: TPS3186
Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study
Abstract number: e15600
Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria
Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT
Abstract number: 601
Screening

Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers
Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT
Abstract number: 3630
A decade of progress: Trends in 5-year survival across 17 cancer types
Abstract number: e23262
The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study
Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT
Abstract number: 10542
Falcon – Exact Sciences’ multi-cancer early detection (MCED) real-world evidence (RWE) registry
Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT
Abstract number: TPS11189
Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study
Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT
Abstract number: 6057
Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing
Abstract number: e17617

On May 22, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, MAY 22, 2025, View Source [SID1234653315]). The trial included patients who had progressed after at least two lines of therapy and were either double-class refractory (immunomodulatory drug [IMiD] and PI) or triple-class exposed (IMiD, PI and anti-CD38 monoclonal antibody). The data will be featured in two oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting on Monday, June 2 at 8:00 AM CDT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In clinical trials, treatment with linvoseltamab monotherapy in later-line settings generated impressive response rates, warranting investigation in earlier lines as well as in combination with other cancer therapies," said Salomon Manier, M.D., Ph.D., Professor of Hematology at Lille University Hospital in France. "While early, these compelling results for linvoseltamab combination therapy demonstrated high rates of clinical activity, even amongst those with previous exposure to the proteasome inhibitors evaluated in the cohorts. We look forward to seeing these results mature to see if these benefits can be maintained."

Linvoseltamab combined with carfilzomib showed strong responses in R/R MM
All treated patients (n=23) had previous exposure to PIs and more than half (n=12) were refractory to at least one PI. Moreover, 48% had baseline soft tissue plasmacytomas, and 39% were over 75 years old, representing a patient population with high-risk features. Of the 21 patients evaluable for efficacy, 11 patients received linvoseltamab 100 mg, and five patients each received linvoseltamab 150 mg or 200 mg prior to initiation of carfilzomib.

With a median follow-up of 15 months, efficacy results across all dose levels showed a 90% objective response rate (ORR; 19 of 21 patients), with 76% (16 of 21 patients) achieving a complete response (CR). At 12 months, the estimated probability of maintaining a response was 87% (n=19; 95% confidence interval [CI]: 56% to 97%) and being progression-free was 83% (n=21; 95% CI: 55% to 94%). A registrational, randomized Phase 3 trial investigating this combination against standard-of-care in the same setting is planned.

Among the 23 patients evaluable for safety, the most common treatment emergent adverse events (TEAEs; >50%) of any grade and Grade ≥3 were neutropenia (65% and 56.5%), cytokine release syndrome (CRS; 61% and 0%), diarrhea (52% and 4%) and thrombocytopenia (52% and 30%). Infections occurred in 91% of patients (Grade ≥3: 43.5%, including one fatality). Serious adverse events (SAEs) occurred in 83% of patients. One dose-limiting toxicity (DLT) of Grade 4 thrombocytopenia during tumor lysis syndrome was observed in the 100 mg dose level, and one Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in the 150 mg dose level.

Additional linvoseltamab combination with bortezomib showed promising clinical activity in R/R MM
Among enrolled patients (n=24), 6 received linvoseltamab at 100 mg and 18 at 200 mg before initiating bortezomib. More than half were refractory to PIs, including 58% to carfilzomib and 13% to bortezomib. Of the 20 patients evaluable for efficacy and with a median duration of follow-up of 9 months, results across dose levels showed an 85% ORR (17 of 20 patients), with 50% (10 of 20 patients) achieving a CR.

The most common TEAEs (>50%) of any grade and Grade ≥3 were CRS (58% and 0%), neutropenia (54% and 50%) and thrombocytopenia (54% and 37.5%). Four patients experienced ICANS (one Grade 1 and three Grade 2). Infections occurred in 75% of patients (Grade ≥3: 38%). SAEs occurred in 83% of patients. Two patients died due to adverse events: one due to pneumonia deemed related to treatment and occurring prior to initiation of bortezomib, and another due to COVID-19 deemed unrelated to treatment. One DLT of Grade 3 cytomegalovirus reactivation was observed in the 200 mg dose level.

The uses of linvoseltamab in combination with either carfilzomib or bortezomib in patients with R/R MM are investigational and have not been approved by any regulatory authority.

Linvoseltamab is approved in the European Union as Lynozyfic for adults to treat R/R MM that has progressed after at least three prior therapies (including a PI, an IMiD and an anti-CD38 monoclonal antibody) and that has demonstrated progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu. In the U.S., the FDA accepted for review the Biologics License Application for linvoseltamab in adults with R/R MM with a target action date of July 10, 2025.

About Multiple Myeloma
As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About LINKER-MM2
LINKER-MM2 is a Phase 1b, open-label clinical trial evaluating linvoseltamab in combination with other cancer treatments in patients with R/R MM. Combination treatments include standard-of-care and novel therapies such as IMiD, PIs, anti-CD38 antibodies, checkpoint inhibitors, and a gamma secretase inhibitor. The primary endpoints are incidence of DLTs (dose-finding portion only) and incidence and severity of TEAEs. Secondary endpoints include ORR, DoR and progression-free survival.

In the carfilzomib cohort, linvoseltamab is administered first with an initial step-up dosing regimen followed by at least two full doses (100, 150 or 200 mg) before initiation of carfilzomib (56 mg/m²). In the bortezomib cohort, the same initial step-up process is followed but linvoseltamab is administered with at least one full dose (100 or 200 mg) before initiation of bortezomib (1.3 mg/m²).

About the Linvoseltamab Clinical Development Program
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders.

In addition to LINKER-MM2, trials include:

LINKER-MM1: Phase 1/2 dose-escalation and dose-expansion trial evaluating the safety, tolerability, dose-limiting toxicities and anti-tumor activity of linvoseltamab monotherapy in R/R MM
LINKER-MM3: Phase 3 confirmatory trial evaluating linvoseltamab monotherapy compared to the combination of elotuzumab, pomalidomide and dexamethasone in R/R MM
Phase 1 trial evaluating linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in R/R MM
LINKER-MM4: Phase 1/2 trial evaluating linvoseltamab monotherapy in newly diagnosed MM
LINKER-SMM1: Phase 2 trial evaluating linvoseltamab monotherapy in high-risk smoldering MM
LINKER-MGUS1: Phase 2 dose-ranging trial evaluating linvoseltamab monotherapy in high-risk monoclonal gammopathy of unknown significance and non-high-risk SMM
LINKER-AL2: Phase 1/2 trial evaluating linvoseltamab monotherapy in R/R systemic light chain amyloidosis
For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 844-734-6643.

About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.

Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

On May 22, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported that its Trial in Progress abstract has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, which is being held May 30 – June 3, 2025 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Bantam Pharmaceutical, MAY 22, 2025, View Source [SID1234653331]). The poster will highlight the company’s ongoing Phase 1 trial evaluating its lead product candidate, BTM-3566, in patients with relapsed/refractory mature B-cell lymphomas. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets difficult-to-treat, aggressive tumors by activating OMA1-ATF4 Integrated Stress Response (ISR), a newly described mitochondrial homeostasis pathway.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 multicenter, prospective, dose-escalation study is focused on enrolling patients in the United States and Canada, with the first U.S. site activated at The University of Texas MD Anderson Cancer Center.

"Patients with relapsed or refractory B-cell lymphomas continue to face significant clinical challenges, particularly those who have progressed following cell therapy or targeted agents," said Dr. Michael Wang, global principal investigator and professor of lymphoma & myeloma at The University of Texas MD Anderson Cancer Center. "The opportunity to investigate BTM-3566 and its novel mechanism of action is especially compelling given its preclinical activity across diverse hematologic tumor models, including those with high-risk features. Advancing BTM-3566 into the clinic represents an important step toward expanding therapeutic options for patients who urgently need more effective treatments."

In the U.S., the study follows a standard 3+3 dose escalation design beginning at 0.3 mg/kg, while the Canadian sub-protocol initiates at 0.9 mg/kg using a single-patient cohort with accelerated dose titration. In both regions, patients receive BTM-3566 orally on Days 1 through 7 of a 14-day cycle. The complementary-dual-country approach accelerates the identification of clinically active doses for lymphoma patients while preserving the scientific rigor required to ensure meaningful clinical impact. It is expected to support future harmonization of U.S. and Canadian data to generate a robust, integrated dataset and inform development strategy.

Primary endpoints are safety and tolerability. Secondary and exploratory endpoints include objective response rate (ORR) by revised Lugano criteria, duration of response (DoR), progression-free survival (PFS), and pharmacokinetic and pharmacodynamic assessments. Initial clinical data from the trial are expected in the second half of 2025.

While the current trial is focused on treating lymphomas through activating the OMA1-ATF4 ISR, the mechanism represents a broader therapeutic opportunity. Recent preclinical findings have shown that BTM-3566 drives significant regressions in biomarker-selected solid tumors – particularly in difficult-to-treat tumor types. Additionally, combination data demonstrate synergy with standard-of-care agents in acute myeloid leukemia, underscoring the broad potential of this mechanism across both hematological and solid tumors. The company intends to advance these findings clinically as product development progresses.

Poster Presentation Details

Title: A phase 1 trial of BTM-3566 in relapsed/refractory mature B cell lymphomas
Presenter: Michael Wang, MD, Department of Lymphoma & Myeloma, MD Anderson Cancer Center
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1st at 10 a.m. to 1 p.m. ET
Abstract Number: TPS7097

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website, View Source The poster presentation will be made available under the News & Resources section of the company’s website shortly after the event.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), Burkitt’s lymphoma, and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). Notably, its anti-tumor activity is independent of tumor genotype, addressing a critical need for therapies capable of delivering robust and durable responses across genetically diverse cancers. With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development, broadening its potential impact for patients with limited treatment options.

Currently, Bantam is conducting ongoing Phase 1 clinical trials in both the U.S. and Canada evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. For more information about the U.S. trial, visit ClinicalTrials.gov and search NCT06792734. For more information about the Canadian trial, visit ISRCTN.com and search ISRCTN15438979.