On December 2, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that the China National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for the Phase Ib/II CLINCH-2 study evaluating ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as well as ATG-022 in combination with pembrolizumab and chemotherapy.

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CLINCH-2 is a Phase Ib/II study that will be led by its principal investigator Prof. Lin Shen at Beijing Cancer Hospital, the lead trial center. The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C). The primary objective of the study is to assess the safety and tolerability of the two combination regimens, while the secondary objectives include evaluating the regimens’ preliminary antitumor activity, assessing ATG-022’s immunogenicity, and characterizing its pharmacokinetic (PK) profile.

Antengene released updated clinical data from the Phase I/II CLINCH study of ATG-022 monotherapy in patients with advanced GC/GEJC at the European Society for Medical Oncology Congress 2025 (ESMO 2025). For details of the dataset, please refer to the press release published on October 20, 2025 (View Source). The results demonstrated clear differentiation for ATG-022 in both safety and efficacy. In the 1.8 mg/kg dose cohort, the incidence of grade 3 or higher treatment-related adverse events was only 18.2%. Moreover, the study did not observe any ocular toxicity or interstitial lung disease, and the incidence of peripheral neuropathy reported in the study was relatively low. The efficacious doses (1.8mg/kg and 2.4mg/kg) have both demonstrated an objective response rate (ORR) of 40%. This is a strong validation of ATG-022’s potential in combination with pembrolizumab and chemotherapy in the frontline setting. In addition, antitumor activity was observed across high, medium, and low CLDN18.2 expression levels, supporting the use of IHC 1+ ≥1% as the enrollment threshold for frontline combination therapy, indicating potential applicability to a much broader patient population compared to other CLDN18.2-targeting therapies. Furthermore, in the basket cohort of other CLDN18.2+ tumor types, efficacy was observed in a gynecologic tumor subtype, providing early proof of concept for potential expansion into tumor types beyond gastric cancer.

Antengene will continue to advance both the ongoing CLINCH study and the newly approved CLINCH-2 study, with plans to share updated results at upcoming medical conferences to further demonstrate the clinical potential of ATG-022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is a CLDN18.2-targeted antibody-drug conjugate (ADC) with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high, low, and ultra-low CLDN18.2 expression.

ATG-022 has been granted two Orphan Drug designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer, and obtained Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for treating CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received at least two prior lines of therapy.

(Press release, Antengene, DEC 2, 2025, View Source;chemotherapy-302630024.html [SID1234661066])

On December 2, 2025 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported top line results from its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM). Glioblastoma is a highly aggressive brain cancer with an average life expectancy of just 12 to 15 months, and a five-year survival rate of under six percent. It has been 20 years since the last improvement to the standard of care for the treatment of ndGBM.

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In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33). To date, approximately 100 ndGBM patients have received treatment with IGV-001 across two clinical studies. In the study, patients in the IGV-001 arm saw measurable patient benefit across multiple metrics compared to the placebo arm. The Company has informed the U.S. Food and Drug Administration (FDA) that it intends to submit a meeting request to discuss the regulatory pathway for IGV-001.

"The data from this trial are highly encouraging and suggest both a clinically meaningful improvement in overall survival for ndGBM patients and a benign safety profile for the therapy," said J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center and the highest enrolling investigator in the Phase 2b trial. "These results represent a potential watershed moment for the treatment of this deadly disease."

"While treatments for many cancers have come a long way, treatments for glioblastoma have not changed much over the years. It is a heartbreaking diagnosis made even harder by how few treatment options there are," said Kelly Sitkin, President and Chief Executive Officer of the American Brain Tumor Association. "Ultimately, what any patient or family member wants is a chance at more time with loved ones, and new treatments for glioblastoma provide that hope for our community."

"Today marks a pivotal moment for both Imvax and for the people affected by ndGBM. For the past decade, the Imvax team has been dedicated to advancing the development of IGV-001, and the results from this Phase 2b study bring us meaningfully closer to achieving that goal. Thanks to the strong support of our investors, Imvax has the resources and expertise to execute on a clear strategy for IGV-001," said John P. Furey, Executive Chair of the Imvax Board of Directors. "We are preparing to meet with FDA to discuss the regulatory pathway for IGV-001 and what we believe is a strongly positive risk-benefit profile, especially given the large unmet medical need in ndGBM. Finally, we are profoundly grateful to the investigators, patients, and their families for their commitment to this study."

About IGV-001 and Glioblastoma

IGV-001 is an autologous biologic-device combination product candidate derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a patient-specific, broad, and durable immune response against tumors. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Orphan Drug Designation to IGV-001 for the treatment of ndGBM. IGV-001 is an investigational therapy and has not been approved by the FDA or any regulatory body.

Glioblastoma is both the most common and most aggressive malignant brain cancer and has resisted significant advances in treatment for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States, and their average life expectancy is 12 to 15 months with the current standard of care. Under six percent of patients survive for five years after diagnosis. The last significant advance in the treatment of ndGBM was the Stupp trial in 2005, which demonstrated a 2.5-month improvement in median overall survival. More than 20 years later, the Stupp protocol – maximal safe resection followed by adjuvant radiotherapy with concurrent temozolomide and subsequent maintenance temozolomide – remains the current standard of care for ndGBM patients.

About the Phase 2b Trial

The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial assessed several endpoints, including progression-free survival (PFS, the primary endpoint), overall survival and safety. The trial did not reach statistical significance on PFS but demonstrated a 6.3 month increase in median overall survival and a favorable safety profile.

The trial enrolled 99 participants in a 2:1 randomization across 19 sites in the United States. Approximately 48 hours after surgical resection of the patient’s malignant tumor, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant concomitant radiotherapy and temozolomide followed by maintenance temozolomide).

(Press release, Imvax, DEC 2, 2025, View Source;utm_medium=rss&utm_campaign=imvax-announces-positive-top-line-data-from-phase-2b-clinical-trial-of-igv-001-in-newly-diagnosed-gbm [SID1234661048])

On December 2, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported that 11 studies featuring the Breast Cancer Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions.

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"These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care," said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. "This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types."

Among the new findings to be presented, one study, "Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]," explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^*

"As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life," said primary study author Dr. Ruth O’Regan, MD. "The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects."

A full list of studies to be presented at the 2025 SABCS conference includes:

Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST
Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants.9*
Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision.10*
Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence.8^*
Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease.11*
Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns.12*
Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples.13*
Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including:

Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18]14
Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10]15
Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19]16
Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23]17
Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST
Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08]18
"The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test," said Schneiders. "With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients."

About the Breast Cancer Index Test

The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7

The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

(Press release, Hologic, DEC 2, 2025, View Source [SID1234661067])

On December 2, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a securities purchase agreement with certain established institutional and accredited investors for a private placement of equity securities (PIPE). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to the investors an aggregate of approximately $50.0 million of ordinary shares and prefunded warrants, at a purchase price per share that is the equivalent of $5.00 per ADS, each ADS representing 500 ordinary shares. The PIPE is structured as a straightforward equity investment with no common warrant coverage. The PIPE financing was led by healthcare-dedicated investors including Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management, LLC, alongside existing shareholders, including Jorey Chernett. The transaction is expected to close on Wednesday, December 3, 2025, subject to customary closing conditions.

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Konik Capital Partners, LLC is acting as the exclusive placement agent for the PIPE.

The net proceeds to the Company from the PIPE are expected to be approximately $46.5 million, after deducting placement agent’s fees and other estimated offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of its lead program paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor currently in clinical trials for both brain cancer and advanced breast cancer, advancing the PD-L1 degrader program, and for general corporate purposes. The Company expects the net proceeds from the PIPE, combined with the existing cash and cash equivalents, will extend its cash runway into the second half of 2028.

The securities sold in this PIPE are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements. Pursuant to the securities purchase agreement, the Company has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (SEC) within 30 days of the closing to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the securities described above under the resale registration statement will only be by means of a prospectus.

(Press release, Kazia Therapeutics, DEC 2, 2025, View Source [SID1234661049])

On December 2, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that at least twelve abstracts highlighting Signatera will be shared at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12.

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The presentations encompass aggregated data from more than 50,000 patients in real-world evidence and prospective clinical studies, demonstrating the prognostic and predictive power of Signatera across diverse breast cancer subtypes and settings. These include real-world studies of Signatera adoption and clinical impact at Yale, Houston Methodist and other leading institutions. Additional highlights include:

Signatera Genome study

In a real-world cohort of 227 patients with triple-negative, HR+/HER2- and HER2+ breast cancers, during surveillance Signatera Genome detected recurrence with a sensitivity and specificity of 100%.

Patients who were Signatera-positive within 3 months of surgery were at a significantly higher risk of distant disease recurrence (HR: 13.1, 95% CI: 1.4-122.1, P = 0.005).
Signatera positivity at any time post-definitive treatment was associated with significantly worse distant recurrence-free survival (HR: 221.2, 95% CI: 131.0-373.4, P <0.0001).
LEADER trial

This phase 2 randomized study aims to evaluate the efficacy of adding the CDK4/6 inhibitor, ribociclib, to adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer who test Signatera-positive during surveillance.

Patients with sustained MRD negativity remained disease-free during extended followup (12−month NPV: RFS=99%, DRFS=100%).
MRD-positive patients initiating ribociclib achieved high rates of ctDNA decrease or clearance, translating to delayed onset of distant recurrence (18.6 vs 5.4 from treatment start).
"We are proud to share our largest dataset for SABCS thus far, featuring the value of Signatera in risk stratification, the early detection of molecular relapse and treatment response monitoring," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The findings from these prospective clinical studies and real-world evidence add important context on how Signatera can provide personalized insights and optimize treatment across all breast cancer subtypes and indications, and the new data with Signatera Genome offer even greater promise for MRD testing."

The full list of presentations at SABCS includes:

December 10, 4:30 PM CT | RF3-04 (Oral Presentation)
Presenter: Heather A. Parsons
Tumor-informed circulating tumor DNA analysis to assess molecular residual disease for prognosis and prediction of benefit from palbociclib in the PALLAS trial

December 10, 5:00 PM CT | PS2-09-04
Presenter: Julia Foldi
Predicting outcomes for patients with mixed ductal/lobular carcinoma of the breast based on circulating tumor DNA positivity patterns

December 10, 5:00 PM CT | PS2-10-03
Presenter: Devora Isserfoff
Impact of Circulating Tumor DNA (ctDNA) monitoring on Patient Anxiety and Clinician Decision-Making in Early-Stage Breast Cancer (PACE-ctDNA)

December 10, 5:00 PM CT | PS2-08-21
Presenter: Amy J. Xu
Circulating tumor DNA (ctDNA) Dynamics in Early-stage Breast Cancer Patients (pts) with Brain Metastases

December 10, 5:00 PM CT | PS2-08-12
Presenter: Julia Foldi
Age-associated divergence in breast cancer: clinical, molecular, and genomic insights from a large real-world cohort

December 10, 5:00 PM CT | PS2-09-20
Presenter: Daniel Stover
Circulating Tumor DNA Dynamics and Anatomical Patterns of Relapse Following Curative Therapy in Early-Stage Breast Cancer

December 10, 5:00 PM CT | PS2-07-26
Presenter: Wassim McHayleh
Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer

December 11, 7:00 AM CT | PD6-07 (Poster Spotlight)
Presenter: Mark Jesus Magbanua
ctDNA dynamics is most predictive of response in treatment-sensitive response-predictive subtypes of breast cancer: Results from the I-SPY2 trial

December 11, 7:00 AM CT | PD5-01 (Poster Spotlight)
Presenter: Arielle J. Medford
Personalized circulating tumor DNA (ctDNA) testing, intervention, and temporal dynamics in ER+/HER2- early-stage breast cancer (LEADER)

December 11, 7:00 AM CT | PD9-01 (Poster Spotlight)
Presenter: Steffi Oesterreich
Comprehensive Genomic Landscape of Invasive Lobular Carcinoma Reveals Distinct Molecular Subtypes

December 11, 12:30 PM CT | PS3-01-05
Presenter: Banu Arun
Prevalence and Characterization of Germline CDH1 Mutations in a Large Real-World Breast Cancer Cohort

December 11, 5:00 PM CT | PS4-02-25
Presenter: Minhal Zaidi
Single Institution experience of longitudinal post-surgical circulating tumor DNA monitoring in patients with HER2+ breast cancer

(Press release, Natera, DEC 2, 2025, View Source [SID1234661068])