On December 12, 2024 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream") (Tokyo:4587) reported its second wholly-owned peptide radiopharmaceutical development candidate arising from the company’s ongoing internal peptide radiopharmaceutical discovery and development efforts (Press release, PeptiDream, DEC 12, 2024, View Source [SID1234649097]). The development candidate ("PD-29875") is a novel first-in-class highly-selective macrocyclic peptide-radioisotope (RI) conjugate against Claudin 18.2 ("CLDN18.2"), a member of the claudin family of proteins that are integral components of tight junctions found in epithelial tissues. CLDN18.2 is expressed in a variety of solid tumors, including gastric cancer, pancreatic cancer, biliary cancer, genitourinary tract cancers, and colorectal cancer, and others.

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!

PD-29875 was discovered using PeptiDream’s proprietary PDPS technology and further optimized at PeptiDream with in vivo imaging and efficacy studies conducted at PDRadiopharma, our wholly owned subsidiary. PeptiDream has initiated IND-enabling studies of PD-29875 and intends to initially develop the therapeutic (225Ac-PD-29875) and paired diagnostic imaging agent (64Cu-PD-29875) for the diagnosis and treatment of gastric cancer. The paired diagnostic imaging agent, which consists of the same peptide and chelator as the therapeutic, will enable us to screen and identify patients, both in clinical trials and in clinical practice, who have CLDN18.2 expressing tumors that are most likely to have a favorable clinical response from PD-29875 treatment. PeptiDream is additionally planning to initiate human Ph0 imaging studies of 64Cu-PD-29875 in 2025, prior to the start of a Phase 1 study.

Gastric cancer is the 5th most common cancer in and the 4th leading cause of cancer death worldwide in 2020, representing 7% of all global cancer diagnoses, with an approximate 5-year survival rate of 32% (worldwide an estimated 1.1 million people were diagnosed with gastric cancer in 2020, with 770,000 deaths), with the incidence expected to increase to ~1.8 million new cases per year by 2040.

"We are extremely excited to announce our second internal peptide-RI clinical development candidate, PD-29875, targeting CLDN18.2 for the potential diagnosis and treatment of gastric cancer, which has a high unmet medical need." said Patrick C. Reid PhD, President & CEO of PeptiDream. "We are preparing to potentially take PD-29875 into human imaging studies in 2025, before bringing the therapeutic and paired diagnostic into clinical development. Our PDPS platform continues to prove extremely effective in discovering novel macrocyclic peptides for the targeted delivery of conjugated radionuclide payloads to tumors, and PeptiDream is focused on creating a robust pipeline of peptide-RI conjugate therapies for the diagnosis and treatment of cancer, both internally and through our collaboration partners."

On December 12, 2024 Tanner Pharma, a global provider of specialty medicine access solutions, reported a collaboration with Agenus, a leading immuno-oncology company, to provide expanded access to botensilimab (BOT) and balstilimab (BAL) (Press release, Tanner Pharma Group, DEC 12, 2024, View Source [SID1234649096]). Through a Named Patient Program (NPP), this initiative offers patients with microsatellite stable colorectal cancer (MSS CRC) and other advanced solid tumors the opportunity to access BOT/BAL based on supporting clinical evidence and medical need.

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!

Tanner Pharma will manage access to BOT/BAL for patients in geographies that allow named patient access to investigational medicines. The NPP ensures that patients, in consultation with their physicians, can access BOT/BAL even before regulatory approval, adhering to all ethical and compliance standards.

BOT and BAL are investigational immunotherapies designed to target challenging cancers, including MSS CRC and other tumors historically resistant to immune-based treatments. Clinical outcomes have demonstrated complete pathological responses in neoadjuvant MSS colon cancer patients and durable tumor responses across multiple cancer types. These results establish BOT/BAL as a treatment option with the potential to redefine standards of care for patients with difficult-to-treat cancers.

On December 12, 2024 PDC*line Pharma, a clinical-stage biotech company developing a new class of immunotherapies for cancers, reported the primary results of its phase I/II clinical trial for PDC*lung01, an innovative off-the-shelf therapeutic cancer vaccine, at the ESMO (Free ESMO Whitepaper)-IO 2024 conference (Press release, PDC Line Pharma, DEC 12, 2024, View Source [SID1234649095]). PDC*lung01, when combined with pembrolizumab, demonstrated significant clinical benefits for stage IV Non-Small Cell Lung Cancer (NSCLC) patients with PD-L1 ≥ 50%, along with a mild safety profile.

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!

"PDC*lung01 in combination with anti-PD-1 showed a very promising and durable response as well as a significant immune response with indications of a relationship with clinical outcome in cohort B2. The data suggest that this combination could offer a clinically meaningful tumor response in stage IV NSCLC patients, along with a compelling safety profile," said Prof Johan Vansteenkiste, emeritus professor in respiratory oncology at KU Leuven in Belgium and chair of the Data and Safety Monitoring Board.

The phase I/II trial (PDC-LUNG-101, NCT03970746) evaluated the safety, tolerability, immunogenicity, and preliminary clinical activity of PDC*lung01 in NSCLC patients. The trial included 67 HLA-A02:01-positive NSCLC patients across five European countries. Patients received six weekly doses of PDC*lung01 through subcutaneous and intravenous administration. It assessed the vaccine in two doses both as a single agent (cohorts A1, A2 for stage II & IIIa NSCLC) and in combination with pembrolizumab (cohorts B1, B2 for stage IV NSCLC). Key clinical activity parameters, such as ORR and PFS, were analyzed in the B1 and B2 cohorts, with primary results reported from the high-dose, B2 cohort. With a database cut-off date on July 18, 2024, the patients’ median follow-up was 19.5 months (95% CI 13.8-25.6).

Highlights: View Source

Immune Response:

56% of patients exhibited tumor antigen-specific CD8+ T-cell responses, with measurable expansions of anti-tumor CD8+ T-cells observed in some cases, up to 2.3% of total CD8+T-cells.

A significant correlation was observed between the amplitude of antigen-specific CD8+ T-cell responses and PFS.
Efficacy:

In the high-dose (B2) cohort consisting of 42 evaluable patients, PDC*lung01 combined with pembrolizumab achieved a confirmed objective response rate (ORR) of 55% (80% CI 43.7%; 65.4%), surpassing the trial’s predefined success criteria (15% absolute increase compared to 39% for external comparator KEYNOTE-042). The Best Overall Response (BOR) according to RECIST 1.1 included 23 confirmed Partial Response (55%) and 12 Stable Disease (29%).

Median progression-free survival (mPFS) was 8.9 months, a 36% improvement (2.4 months longer) compared to pembrolizumab alone (KEYNOTE-042).

The Disease Control Rate (DCR) was 76% (80% CI: 83.8, 65.4) and Clinical Benefit Rate (CBR) was 64%. The 9-month PFS rate was 50% (80% CI 39.1%; 60.9%). Median duration of response and median overall survival were not reached.
Safety:

In 48 patients who received at least one dose of PDC*lung01 in the B2 cohort, PDC*lung01 exhibited a mild safety profile. Most treatment-emergent adverse events (TEAEs) were grades 1-2, with only one grade 4-related TEAE reported.

Only 2% of related TEAEs led to discontinuation, compared to 9.1% for pembrolizumab alone in the KEYNOTE-042 study.
Further data from the trial will become available at the end of 2025, once all patients have reached two years of follow-up. Based on these very encouraging findings, PDC*line Pharma is preparing a randomized phase IIb study in untreated stage IV NSCLC (and PD-L1 ≥50%) in combination with pembrolizumab, with initiation planned in 2026.

"We are thrilled by these promising results, which position PDC*lung01 as the first cancer vaccine of its kind tested in metastatic NSCLC with high PD-L1 expression. Its unique mechanism of action and favorable safety profile make it an excellent complement to pembrolizumab and other existing or emerging therapies for this patient population. Moreover, our off-the-shelf technology has significant potential for expansion into other clinical settings and indications. Our upcoming randomized Phase IIb trial is a critical step toward confirming clinical proof of concept and fostering collaborations with industrial partners to bring our innovative technology to market," said Eric Halioua, CEO of PDC*line Pharma.

About PDC*lung01:

PDC*lung01 is an off-the-shelf cancer vaccine composed of irradiated human Plasmacytoid Dendritic Cells (PDC*line) loaded with peptides derived from key tumor antigens (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin, Melan-A). These professional antigen-presenting cells prime and boost cytotoxic CD8+ T-cells, making the vaccine synergistic with checkpoint inhibitors like pembrolizumab.

On December 12, 2024 TerSera Therapeutics LLC reported the presentation of new real-world analyses on the use of goserelin 3.6 mg and goserelin 10.8 mg in premenopausal women with breast cancer (Press release, TerSera Therapeutics, DEC 12, 2024, View Source [SID1234649094]). These data were presented in a poster session at the 2024 San Antonio Breast Cancer Symposium, held December 10-13 in San Antonio, TX.1 A copy of the poster is available here.

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!

"Ovarian function suppression (OFS) with gonadotropin-releasing hormone agonists (GnRHas) is an essential component of therapy for a large proportion of pre- or perimenopausal women with hormone-sensitive breast cancer"

Post this
This was a retrospective, observational, non-inferiority study using structured, de-identified, patient-level data and curated progress notes from U.S. electronic medical record (EMR) data from the ConcertAI Patient360 Breast Cancer Dataset. The objective of this study was to compare real-world treatment outcomes among breast cancer patients treated with goserelin 3.6 mg and 10.8 mg.

The primary outcome was the real-world event-free survival (rwEFS) rate at 12 months to assess the non-inferiority of the goserelin 10.8 mg dose given every 12 weeks vs. the 3.6 mg dose given every 4 weeks. The 12-month rwEFS rates for goserelin 3.6 mg and goserelin 10.8 mg, respectively, were 76.6% vs. 79.2% (treatment difference: 2.7% [95% CI: -1.8%, 7.0%]) which supports the non-inferiority of goserelin 10.8 mg to goserelin 3.6 mg at the prespecified -15% margin based on previously published oncology trials. In evaluating time to discontinuation, this study also found that more patients remained on goserelin 10.8 mg than 3.6 mg at years 1 and 2 post treatment initiation (51.2% vs. 39.6% and 32.4% vs. 23.1%, respectively), supporting previously published data in a separate real-world evidence analysis of breast cancer patients receiving goserelin 10.8 mg.2

"Ovarian function suppression (OFS) with gonadotropin-releasing hormone agonists (GnRHas) is an essential component of therapy for a large proportion of pre- or perimenopausal women with hormone-sensitive breast cancer," said Kelly E. McCann, M.D., Ph.D., assistant clinical professor of medicine at the UCLA Health David Geffen School of Medicine. "ZOLADEX 3.6 mg given every 4 weeks is the only FDA-approved GnRHa for women with breast cancer. Our data suggests that the 10.8 mg dose given every 12 weeks may also be an effective option."

U.S. INDICATIONS

ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for:

Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Palliative treatment of advanced carcinoma of the prostate.
ZOLADEX 3.6 mg is also indicated for:

Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.
Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.
Palliative treatment of advanced breast cancer in pre- and perimenopausal women.
IMPORTANT SAFETY INFORMATION

Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX.

ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding.

Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy.

Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare.

Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice.

Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.

Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated.

Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues.

ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.

GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation.

Depression may occur or worsen in women receiving GnRH agonists.

Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients.

In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis.

The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%).

The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%).

The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients.

For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%).

For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%).

In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone.

Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/safety/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or [email protected].

About HR-positive breast cancer

Breast cancer is the second most commonly diagnosed cancer and one of the leading causes of cancer-related deaths worldwide.3 In the United States, over 310,000 women will be diagnosed with breast cancer this year; 40,000 will be under the age of 50.4 Approximately 75% of diagnosed cases in women under age 50 are considered to be hormone positive (HR+) breast cancer. Compared to older women, young women generally face more aggressive cancers and lower survival rates.5-7 Recent studies have shown that breast cancer before age 40 differs biologically from the cancer faced by older women.6,7

About ZOLADEX (goserelin implant)

ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks. Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries.

On December 12, 2024 Agendia, Inc., reported it will be presenting new data highlighting MammaPrint and BluePrint utility in guiding treatment decisions for patients with early-stage breast cancer (Press release, Agendia, DEC 12, 2024, View Source [SID1234649093]). The findings will be presented in two spotlight presentations and two posters at the San Antonio Breast Cancer Symposium 2024 (SABCS), on Wednesday, December 11th and Thursday, December 12th.

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!

One poster spotlight, titled "Association of MammaPrint with gene expression pathways predictive of resistance to cyclin-dependent kinase inhibition," presented by Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center, examined 5,657 patients with early-stage HR+HER2- tumors enrolled in the ongoing prospective, observational FLEX Trial (NCT03053193). The analysis evaluated the correlation between MammaPrint and gene expression patterns associated with Retinoblastoma (Rb) loss-of-function and CDK4 independent cellular proliferation to identify which MammaPrint Risk categories may be resistant to CDK4/6 inhibition.

A linear correlation was observed between increasing MammaPrint Risk and increasing Rb loss-of-function gene expression, suggesting that MammaPrint High 2 tumors have the highest probability of CDK4/6 resistance. Additionally, MammaPrint High 2 tumors were most likely to exhibit high cell proliferation independent of CDK4 activity (43.0%), in comparison to Ultra Low (0.1%), Low (0.5%), and High 1 (1.8%) tumors (p < 0.001). These data provide the first evidence for the utility of a commercially available signature to potentially predict resistance to CDK4/6 inhibition and help patients receive more targeted and individualized therapies.

The second poster spotlight, titled "MammaPrint and BluePrint Predict Pathological Response to Neoadjuvant Chemotherapy in Patients with HR+HER2- Early-Stage Breast Cancer Enrolled in FLEX," presented by Joyce O’Shaughnessy, MD, National Principal Investigator of the FLEX Study, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the Sarah Cannon Research Institute in Dallas, TX, evaluated MammaPrint and BluePrint in predicting pathological response to neoadjuvant chemotherapy among 457 HR+HER2- breast cancer patients enrolled in FLEX.

Rates of Pathological Response (PR), including pathological Complete Response (pCR) and minimal residual cancer burden (RCB-I), were highest in High 2 Basal (43.4%) and Luminal B (21.4%) tumors, with High 2 tumors overall showing better PR rates (32.7%) compared to High 1 tumors (9.5%). Multivariate analysis indicated that only MammaPrint High 2 was significantly associated with likelihood of PR, after adjusting for clinical confounders. Overall, MammaPrint and BluePrint proved effective in predicting neoadjuvant chemosensitivity in HR+HER2- breast cancer, which may enable downstaging and improve overall outcomes.

"The findings from these two studies highlight the ability of genomic testing using MammaPrint and BluePrint to predict patient response to therapies like chemotherapy, and may be able to predict benefit from CDK4/6 inhibitors," said Dr. O’Shaughnessy. "The ongoing data that continues to be generated through FLEX is building evidence that these tests may help unlock optimal treatment plans based on the patient’s tumor biology."

Abstracts Accepted as Posters

Neoadjuvant Chemotherapy for T3 Tumors in the Era of Precision Medicine – Biology is Still King (Rahman, R., et al.)
A pooled analysis was conducted on 404 clinical T3 breast cancer patients from the NBRST, FLEX, and MINT trials undergoing neoadjuvant chemotherapy. MammaPrint (MP) and BluePrint (BP) subtyping showed higher pathological complete response (pCR) rates across all MP High Risk subtype tumors (Basal (32.5%, HER2 53.7%, Luminal B 8.6%) compared to MP Low Risk Luminal A subtype tumors (0% pCR). Menopausal status, nodal status, and grade were not significant predictors of pCR response. High Risk tumors had significantly higher pCR rates, suggesting MammaPrint Low Risk, cT3 tumors are unlikely to achieve pCR to neoadjuvant chemotherapy, suggesting these patients may avoid neoadjuvant chemotherapy despite their large tumor size.

FLEX: A Real-World Evidence, Full Transcriptome Study in 30,000 Patients with Early-Stage Breast Cancer (Maganini, R., et al.)
The FLEX Study, a large, multi-center, real-world evidence, whole transcriptome, observational breast cancer study (NCT03053193), has grown substantially since its launch in April 2017. With more than 17,000 patients enrolled across 100 sites in the US and around the world, FLEX includes over 40 sub-studies in several topics. Participants are of all racial and ethnic backgrounds with stage I, II, or III early-stage breast cancer, aiming for a representative data set. The study has produced more than 10 clinical evidence pieces on diversity and includes 1,377 self-identified Black, 530 Latin American/Hispanic, and 353 Asian and Pacific Islanders, making FLEX the most diverse study on EBC patients to date.

"These data significantly enhance our understanding of MammaPrint and BluePrint’s growing clinical applications," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "Our findings reinforce the importance of precision medicine, as it allows us to tailor treatment strategies, including neoadjuvant chemotherapy consideration, incorporating immunotherapies, and potentially sparing patients from the harms of unnecessary chemotherapy. As we continue to gather data from studies like FLEX, we are solidifying the role of these genomic assays in guiding personalized treatment decisions for breast cancer patients."

About Agendia