Cidara Therapeutics to Present New Preclinical Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

On November 30, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported the company will present new preclinical data on its novel, dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress (Press release, Cidara Therapeutics, NOV 30, 2023, View Source [SID1234638065]). Cidara will also present new preclinical data on CBO421, its first-in-class CD73 targeting DFC. The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.

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Presentation details are summarized below:

Title: Discovery of a Novel, Dual CD73 & PD-1 Targeting Multispecific Drug Fc-Conjugate (DFC) for the Treatment of Cancer
Presenter: James Levin, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET

Title: Discovery of CBO421, a First-in-Class Drug Fc-Conjugate (DFC), Targeting CD73 in Cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET

Gilead’s Leadership in Metastatic Breast Cancer Showcased With New Trodelvy Data at San Antonio Breast Cancer Symposium 2023

On November 30, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported it will present new data at San Antonio Breast Cancer Symposium (SABCS) 2023, supporting the use of Trodelvy (sacituzumab govitecan-hziy) in certain metastatic triple-negative breast cancer (mTNBC) and pre-treated HR+/HER2- metastatic breast cancer (mBC) patients.

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Data featured in eight presentations include an analysis of clinical outcomes by age from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- mBC, as well as a qualitative analysis of the experiences and perspectives of patients, caregivers and clinicians on clinical meaningfulness in mBC treatment decision-making. The study adds to a needed body of research exploring the importance of patient-centered interpretations of clinical meaningfulness (e.g., survival, quality of life).

"Trodelvy is the first approved Trop-2-directed ADC to significantly improve survival in both second-line metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "The data being presented at SABCS add to the breadth of evidence reinforcing Trodelvy’s use in these two difficult-to-treat breast cancers. Additionally, the real-world data being presented in metastatic breast cancer provide insights on quality of life and other measures of health to inform both providers and patients in making treatment decisions."

Table of Accepted Abstracts (all times CDT):

Abstract Disposition

Abstract Title

Poster # PO1-05-09

Wednesday, Dec. 6

12:00 PM

ASCENT-07: A Phase 3, Randomized, Open-Label Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with HR+/HER2- Inoperable, Locally Advanced, or Metastatic Breast Cancer Post-Endocrine Therapy

Poster # PO1-06-10

Wednesday, Dec. 6

12:00 PM

Overall Survival Results From EVER-132-001, a Phase 2B Single-Arm Study of Sacituzumab Govitecan in Chinese Patients with Metastatic Triple-Negative Breast Cancer

Poster # PO1-04-06

Wednesday, Dec. 6

12:00 PM

Exposure-response Analyses of Sacituzumab Govitecan Efficacy and Safety in Patients with Metastatic Breast Cancer

Poster # PO1-06-08

Wednesday, Dec. 6

12:00 PM

Treatment Utilization by Race and Insurance Type Among TNBC Patients

Poster # PO1-10-06

Wednesday, Dec. 6

12:00 PM

Understanding Clinical Meaningfulness in Metastatic Breast Cancer Treatment Decision-Making: Experiences and Perspectives of Patients, Caregivers, and Clinicians

Poster # PO2-05-03

Wednesday, Dec. 6

5:00 PM

Costs Associated with Adverse Events in Patients Receiving Treatment for Hormone Receptor Positive/Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer

Poster # PO2-05-02

Wednesday, Dec. 6

5:00 PM

Real-World Experience of Patients Receiving Treatment for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer: A Global Analysis of Symptoms and Side Effects

Poster # PO5-21-09

Friday, Dec. 8

12:00 PM

Clinical Outcomes by Age Subgroups in the Phase 3 TROPiCS-02 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in HR+/HER2‒ Metastatic Breast Cancer

Trodelvy is recommended as a category 1 preferred treatment for second-line mTNBC and a category 1 preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).1

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in almost 50 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy is also approved in the U.S., the European Union, and multiple other global markets to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer. In the U.S., Trodelvy also has accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer (UC); see below for the full U.S. indication for Trodelvy.

Trodelvy is also being developed for potential investigational use in other TNBC, HR+/HER2- and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

U.S. Indications for Trodelvy

In the United States, Trodelvy is indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold Trodelvy until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 64% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever. Administer G-CSF as clinically indicated or indicated in Table 1 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 64% of all patients treated with Trodelvy and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. 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 Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

In the TROPHY study (locally advanced or metastatic urothelial cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, any infection, alopecia, decreased appetite, constipation, vomiting, rash, and abdominal pain. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients

On November 30, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present new data and study results across its Precision Oncology and hereditary cancer platforms at the 2023 annual San Antonio Breast Cancer Symposium (SABCS) (Press release, Exact Sciences, NOV 30, 2023, View Source [SID1234638066]).

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A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. (PRNewsfoto/EXACT SCIENCES CORP)

"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world’s most prestigious, breast cancer-focused organizations."

In cooperation with several leading breast cancer research organizations, Exact Sciences will present late-breaking data and a study included in the SABCS press program. Results from Puerto Rico will also detail germline findings for a cohort of women, most of whom had a personal or familial history of breast cancer. The results suggest a distinct genetic background for hereditary cancer predisposition in the study population.

Exact Sciences will also host a discussion about the Oncotype DX Breast Recurrence Score test and the RSClin Tool. Christy Russell MD, VP Medical Affairs, Exact Sciences; Jennifer Racz, MD, Director, Oncology Medical Affairs, Exact Sciences; and Jay Andersen, MD, Co-Director, Compass Breast Specialists and Associate Chair, US Oncology Breast Cancer Research Committee; will review the development and validation of the RSClin Tool in patients with node-negative, early-stage breast cancer as well as discuss its utility for patients and providers.

The discussion will take place:

When: Thursday, December 7th, 4:00-5:00 p.m. CT
Where: Exhibit Hall Product Theater A, Henry B. Gonzalez Convention Center, San Antonio, Texas

Exact Sciences will present the following data at SABCS 2023:

1.

Title: Magnetic Resonance Imaging and a 12-Gene Expression Assay to Optimize Local Therapy for Ductal Carcinoma In Situ: 5-year clinical outcomes of E4112 – Chosen for SABCS Press Program

Summary: This prospective trial, the first to evaluate the predictive ability of the 12-gene DCIS score, provides data regarding the omission of radiation therapy after surgery in patients with DCIS breast cancer who have low DCIS score results, and the benefit of radiation therapy in patients with intermediate/high DS results.

Oral Presentation ID: GS03-01: Friday, December 8, 2023, 8:15-11:15 a.m.
2.

Title: Impact of age and ovarian function suppression (OFS) on endocrine response to short preoperative endocrine therapy (ET): Results from the multicenter ADAPTcycle trial Chosen as Late Breaking Abstract at SABCS

Data embargoed until: 7:15 a.m. CT on Friday, December 8

Presentation ID: LBO1-05: Friday, December 8, 2023, 12:00-12:45 p.m.

3.

Title: Comparison of whole exome, whole transcriptome genomic profiling and targeted sequencing with 50-gene panels

Summary: A comparison of the OncoExTra whole-exome, whole-transcriptome, comprehensive genomic profiling test to three commercially available and one custom 50-gene panels in a cohort of breast cancer patients. The study determined the frequency of patient tumors that would have had no actionable alteration identified when employing each of the 50-gene panels, when an actionable alteration identified by the OncoExTra test was present, across the three different breast cancer subtypes. The highest proportion of patients was missed (no actionable finding) by 50-gene panels when the cancer was the TNBC subtype and the lowest for HER2+.

Presentation ID: Poster ID PO5-13-05: Friday, December 8, 2023, 12:00-2:00 p.m. (Poster Session 5)

4.

Title: Classifying HER2-low breast cancer using a combination of ERBB2 mRNA expression and altered genes

Summary: Comparison of ERBB2 gene expression, measured using mRNA levels, with HER2 (encoded by ERBB2 gene) protein expression, measured by IHC/FISH. A comparison of altered biomarkers across HER2 protein expression categories was also made. ERBB2 expression levels and alterations in selected biomarkers were used to train a logistic regression classifier to predict HER2 protein expression status. Preliminary results indicate that some HER2-0 samples were classified as HER2-low by the classifier.

Presentation ID: Poster ID P05-13-06: Friday December 8, 2023, 12:00 -2:00 p.m. (Poster Session 5)

5.

Title: Prevalence of genomic alterations in Xerna tumor microenvironment subtypes in triple negative breast cancer patients

Summary: 203 triple negative breast cancer tumor samples were assigned to four different Xerna tumor-microenvironment categories (high versus low immune score, high versus low angiogenic score) based on gene expression of about 100 genes. The prevalence of actionable alterations in biomarkers was then determined across these four tumor microenvironment subtypes. About half of cancer samples had high immune scores, suggesting possible response to ICI therapy. More than half of patient samples carried actionable alterations. Together, these findings suggest the possibility of novel combination therapies in some TNBC patients.

Presentation ID: Poster ID PO2-06-10: Wednesday Dec 6, 2023, 5:00-7:00 p.m. (Poster Session 2)

6.

Title: Hereditary cancer genetic testing in Puerto Rican females

Summary: Nearly one thousand Puerto Rican females were tested with a hereditary cancer panel containing 29 genes. 90 (9.5%) individuals had a pathogenic or likely pathogenic alteration in their germ line at one or more of these genes. The proportion of individuals carrying a pathogenic/likely pathogenic variant at a cancer gene is within the range reported for other Caribbean countries. However, there was no evidence for enrichment of alterations at BRCA1, BRCA2 and PALB2 as observed in other Caribbean countries. The study also denotes a lack of genetic testing amongst specific disparate populations.

Presentation ID: Poster ID: PO1-08-08: Wednesday, December 6, 2023, 12:00 p.m.-2:00 p.m. (Poster Session 1)

7.

Title: Concordance Study of Oncotype DX Breast Recurrence Score Results from Paired Breast Cancer Core Needle Biopsies and Surgical Excision Specimens

Summary: Comparison of Oncotype DX Recurrence Score results for paired core needle biopsy and surgical samples of the same tumor without intervening systemic therapy, which found high concordance between the two.

Presentation ID: PO4-08-09: Thursday, December 7, 2023, 5:00-7:00 p.m. (Poster Session 4)

8.

Title: Comparison of the cost-effectiveness of multigene assays for HR+/HER2- node-negative early-stage breast cancer in the US

Summary: Compares the cost-effectiveness of using different genomic assays for treatment decisions in HR+HER2- early breast cancer (Oncotype DX, MammaPrint, EndoPredict, and Prosigna ROR) relative to that of using clinical-pathological features alone in the U.S. The modeling found that all were cost-effective as additions to clinical-pathological features, with the Oncotype DX test providing the greatest cost savings among the four.

Presentation ID: PO1-01-10: Wednesday, December 6, 2023, 12:00 -2:00 p.m. (Poster Session 1)

9.

Title: A comparison of chemotherapy recommendations by NPI, Predict, and Oncotype DX testing in UK women with early node-positive breast cancer

Summary: Comparison of the Oncotype DX Recurrence Score test, the Nottingham Prognostic Index, and the Predict Breast Cancer tool in risk stratification and association with chemotherapy recommendations in HR+HER2- node-positive early breast cancer. Of the three, the Oncotype test was the most strongly associated with chemotherapy recommendation.

Presentation ID: PO1-14-05: Wednesday, December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

10.

Title: Update of RSClin tool with extended TAILORx follow-up and development and validation of a new tool for risk of late distant recurrence

Summary: Update of the TAILORx findings with longer follow-up and resulting refinements to the RSClin tool for estimating 10-year risk of distant recurrence in HR+HER2- early breast cancer. A new tool specifically to estimate late (5-10 year) distant recurrence risk is also presented.

Presentation ID: PO1-02-02: Wednesday, December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

11.

Title: Irish National Analysis of the Clinical and Economic impact of 21-gene Oncotype DX testing in Early-Stage, 1-3 lymph node-positive, Hormone Receptor positive (HR+), HER2-Negative (HER2-), Breast Cancer (BC)

Summary: An analysis of the impact of Oncotype DX testing in a N1 (disease with 1-3 positive LN) breast cancer population from 2 Irish cancer centers identified a 55% reduction in chemotherapy use with savings of over €1 million. The objectives of this study were to examine the clinical and economic impact of Oncotype DX testing on treatment decisions in N1 patients at a national level with a larger patient population, and to examine changes in the ordering of Oncotype DX tests pre- and post-RxPONDER data. This study extended the analysis to 5 Irish cancer centers.

Presentation ID: PO5-02-04: Friday, December 8, 2023, 12:00-2:00 p.m. (Poster Session 5)

12.

Title: Real-world application of a 21-gene recurrence score in a Swiss single center breast cancer population. A comparative analysis of treatment administration before and after TAILORx

Summary: A comparison of chemotherapy recommendations and use before and after TAILORx. There were some differences in treatment recommendations after TAILORx that included increased recommendation for addition of chemotherapy to endocrine therapy, specifically among younger women, but there were no significant changes in chemotherapy administration.

Presentation ID: Poster Number: P1-14-02: Wednesday December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

Guardant Health to present data at San Antonio Breast Cancer Symposium demonstrating utility of liquid biopsy in biomarker identification, therapy selection and residual disease detection

On November 30, 2023 Guardant Health, a leading precision oncology company, reported the company will present data showing the utility of liquid biopsy tests in the management of breast cancer patients at the San Antonio Breast Cancer Symposium, December 5-9 in San Antonio, Texas (Press release, Guardant Health, NOV 30, 2023, View Source [SID1234638083]). Highlights of the eight poster presentations include the use of blood-based testing to identify actionable biomarkers and predict therapy response in advanced breast cancer, and to detect residual disease and predict recurrence in patients with early-stage breast cancer.

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"We look forward to sharing new data in San Antonio demonstrating the utility of liquid biopsy in advancing the practice of precision oncology for patients with breast cancer," said Craig Eagle, Guardant Health chief medical officer. "The presentations will show how comprehensive genomic profiling and residual disease detection using blood-based testing provide critical insights to help oncologists develop personalized treatment plans that can improve patient outcomes."

Two studies were selected for spotlight discussions:

The PlasmaMATCH study assessed the feasibility of ctDNA genomic profiling for actionable biomarker detection and therapy selection in patients with advanced breast cancer. This research explores the use of ctDNA at multiple points in time to predict therapy response in patients on targeted therapy, including establishing thresholds that best predict clinical outcomes. Study results show the use of longitudinal sampling and ctDNA assessment may help in understanding, predicting and preparing for clinical outcomes in patients receiving systemic therapy.
In a large feasibility study of over 300 patients with early-stage breast cancer, samples were collected about two years after curative-intent adjuvant chemotherapy and tested with Guardant Reveal, using epigenomic technology to assess for the presence of ctDNA. The study found ctDNA detection after adjuvant therapy was prognostic for distant recurrence, with a median lead time between detection and clinically observed disease recurrence of 7.9 months and high specificity. The study also notes that ctDNA was detected up to 28.6 months prior to clinical recurrence detection.
Guardant Health poster presentations

Guardant360 and GuardantOMNI

The prognostic and predictive impact of circulating tumor DNA (ctDNA) dynamics in patients with metastatic Triple Negative Breast Cancer (TNBC) on olaparib based therapy: Results from Cohort E of the PlasmaMATCH trial (Poster spotlight discussion PS06-04)
Guardant360 CDx

Cell-free tumor DNA analysis in advanced or metastatic breast cancer patients enrolled in the German registry study PRAEGNANT (Poster P04-05-03)
Guardant360

CDK4/6 inhibition is a potential vulnerability in NF1-depleted ER+ breast cancer (Poster GS01-08)
Enhancing Informative Outcomes with Liquid Biopsy in a Real-World Population of Patients with Advanced Breast Cancer: Analysis of the SOLTI-1903 HOPE Study (Poster P04-14-02)
Detection of SPEN mutations in advanced breast cancer by circulating tumor cell-free DNA (Poster P05-14-07)
Guardant Reveal

Analysis of ctDNA for the detection of minimal residual disease (MRD) using a tissue-free, multiomic assay in patients with early-stage breast cancer (Poster spotlight discussion PS06-06)
Guardant INFORM

A bedside-to-bench translational analysis demonstrates that NF1 alterations promote CDK4/6 inhibitor (CDK4/6i) resistance in hormone receptor-positive (HR+) metastatic breast cancer (mBC) ( Poster PO1-23-09)
Real-world (RW) utilization and patient outcomes across three CDK4/6 inhibitors in metastatic breast cancer (mBC) (Poster P04-18-02)
The full abstracts are available on the official SABCS 2023 website.

Immix Biopharma to Present at the 2023 JMP Securities Hematology and Oncology Summit

On November 30, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that it will present and host institutional investor meetings at the 2023 JMP Securities Hematology and Oncology Summit (Press release, Immix Biopharma, NOV 30, 2023, View Source [SID1234638067]).

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The JMP Securities Hematology and Oncology Summit

Presentation Date: Tuesday, December 5, 2023
Presentation Time: 3:30 pm ET
Location: Virtual
Webcast: Link
Investor Meetings: The IMMX Team will be available for institutional investor meetings during the conference.
The presentation will be broadcast live and archived on www.immixbio.com under "Events & Presentations" in the Investor Relations section. A replay of the webcast will be available on the Company’s website for approximately 90 days.