Keytruda (pembrolizumab) / Merck (MSD) - LARVOL DELTA

Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine (SABCS 2025) - P1/2, P3 | "Coadministration w/ an anti-PD-1 CPI, the vaccine response is reinforced, counteracting the immuno-suppressive tumor microenvironment.MethodsThis phase I/II study evaluated the Bria-IMT regimen: low-dose cyclophosphamide (Day –2) followed by SV-BR-1-GM and CPI (pembrolizumab or retifanlimab), then low-dose local peg- interferon α. On basis of these results, a randomized phase III trial comparing the Bria-IMT regimen to physician's choice is ongoing (NCT06072612). Trial information: NCT03328026."

IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Triple Negative Breast Cancer • CTCs • HER-2 • IFNG • PD-L1 • PGR

Impact of Access to CGP-Guided Recommended Therapies on Overall Survival in Invasive Lobular and Ductal Carcinomas: Insights from theC-CAT Registry (SABCS 2025) - "A total of 55 ILC patients (12%) achieved recommended therapy, most commonly with pembrolizumab monotherapy (n=11) or capivasertib-based regimens (n=10). This large nationwide registry analysis demonstrates that access to CGP-guided recommended therapy is associated with a significant improvement in OS in ILC. Notably, despite limited availability of targetable alterations and trial opportunities in ILC, meaningful survival benefit was observed. These findings underscore the clinical importance of expanding access to CGP-driven recommended therapies for all breast cancer patients, and highlight the value of large-scale real-world evidence in rare subtypes such as ILC."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Triple Negative Breast Cancer • CDH1 • HER-2 • PIK3CA • TP53

Backbone optimization with dose-dense anthracyclines and prophylactic G-CSF improves pCR without added febrile neutropenia in pembrolizumab-treated TNBC: real-world evidence from Latin America (SABCS 2025) - "These findings highlight the relevance of backbone optimization when integrating immunotherapy into TNBC treatment and provide valuable evidence from underrepresented regions. Disclosure of prior presentation: Portions of these data were previously presented at SCOM (Chile); this submission includes updated cohort size, ACdd utilization, and expanded efficacy and safety analyses."

Clinical • HEOR • Real-world • Real-world evidence • Breast Cancer • Triple Negative Breast Cancer

Neosaci-io: neoadjuvant sacituzumab govitecan (sg) + pembrolizumab (pb) in patients (pts) with early-stage tnbc experiencing suboptimal response to keynote-522 (SABCS 2025) - P2 | "In preliminary analyses, we identified that ≤80% tumor reduction after 4 cycles of paclitaxel+carboplatin (PC) + pembrolizumab (Pb) predicted a pCR rate of only ~20%, defining a biologically aggressive subgroup at risk of early recurrence and reduced survival. These data provide the first evidence of SG+Pb as an effective treatment option in pts with high-risk, early-stage TNBC experiencing poor response to PC+Pb (pCR=48% vs 20% in historical controls), with no new safety signals. Correlative proteomic (including TROP2 IHC), genomic, and immunological studies are ongoing."

Clinical • Breast Cancer • Triple Negative Breast Cancer

Impact of neoadjuvant pembrolizumab on ovarian function in young patients with triple-negative breast cancer (TNBC): Longitudinal analysis from NeoSTOP and NeoPACT trials (SABCS 2025) - "We utilized serial serum samples and data from two completed neoadjuvant trials, NeoSTOP (NACT: carboplatin + paclitaxel➔AC or carboplatin + docetaxel) and NeoPACT (NACT+P: carboplatin + docetaxel + pembrolizumab) to compare ovarian toxicity of chemotherapy and chemoimmunotherapy. To our knowledge this is the first report on impact of pembrolizumab on ovarian function and recovery in young premenopausal patients with breast cancer. Our findings indicate that immediate post-NACT/NACT+P hormone levels are in the postmenopausal range in the majority of patients and thus are not reliable indicators of long-term ovarian toxicity. Longitudinal analysis shows biochemical hormone recovery in 44%-100% of patients depending on the hormone assessed."

Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Trofuse-032: a phase 3, randomized study of pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer or hormone receptor-low-positive (HR-low+)/ human epidermal growth factor receptor 2-negative (HER2−) breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan or sac-TMT (also known as MK-2870/SKB264), a novel antibody-drug conjugate composed of an anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker, has demonstrated significant PFS and OS benefits vs chemo in patients with metastatic TNBC...Participants are randomized 1:1 to neoadjuvant pembro plus sac-TMT followed by pembro plus paclitaxel plus carboplatin (arm 1) vs pembro plus paclitaxel plus carboplatin followed by pembro plus doxorubicin or epirubicin plus cyclophosphamide (arm 2; Table)...Secondary endpoints include OS, pCR-no DCIS (ypT0 ypN0), distant progression- or distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment is ongoing."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TACSTD2

Trofuse-012: a phase 3, randomized study of adjuvant sacituzumab tirumotecan plus pembrolizumab vs treatment of physician's choice in participants with triple-negative breast cancer who received neoadjuvant therapy and did not achieve a pathological complete response at surgery (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264) is a novel antibody-drug conjugate composed of anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker (average drug/antibody ratio, 7.4)...This study (NCT06393374) evaluates adjuvant sac-TMT plus pembrolizumab vs treatment of physician's choice (TPC; pembrolizumab ± capecitabine) in participants with TNBC who received neoadjuvant therapy and did not achieve pCR at surgery. This phase 3, multicenter, open-label study is enrolling participants ≥18 years old with centrally confirmed TNBC per most recent American Society of Clinical Oncology/College of American Pathologists guidelines...Secondary endpoints are OS, distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment began Q2 2024."

Clinical • P3 data • Surgery • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Herthena-breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer (SABCS 2025) - P2 | "There is a need for improved neoadjuvant therapy to increase the rate of pathological complete response (pCR), as patients who do not achieve pCR have a high risk of recurrence, and to reduce risk of long-term toxicities associated with cyclophosphamide and anthracyclines...This phase 2 study (NCT06797635) is evaluating neoadjuvant HER3-DXd + pembrolizumab administered before or after carboplatin + paclitaxel + pembrolizumab for early-stage TNBC or HR-low+/HER2− breast cancer. Eligible participants are adults (≥18 y) with untreated, locally advanced nonmetastatic (AJCC stage cT1c, N1-N2 or cT2-cT4, N0-N2) TNBC or HR-low+/HER2− breast cancer...Primary endpoints are safety (Part 1 and 2) and pCR (ypT0/Tis ypN0) rate (Part 2). Enrollment is ongoing."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • HER-2 • PD-L1

Impact of KEYNOTE-522 on BneoCT: An Institutional Quality Measure Improvement Analysis (SABCS 2025) - "While multiple factors likely contributed, we believe that results from the KEYNOTE-522 trial, which demonstrated that the addition of pembrolizumab to neoadjuvant chemotherapy in high-risk early-stage TNBC significantly improved pathologic complete response (pCR) rates and event-free survival, followed by the National Comprehensive Cancer Network's (NCCN) endorsement of KEYNOTE-522 in May 2021 (NCCN Version 4.2021), was a critical driver for earlier multidisciplinary coordination and greater utilization of neoadjuvant therapy pathways... The integration of KEYNOTE-522 into the NCCN Guidelines in May 2021 played a substantial role in driving improvements in the BneoCT quality measure over the subsequent years. This quality measure improvement analysis illustrates how high-impact clinical trial data, when rapidly translated into national guidelines, can meaningfully influence patient care outcomes and institutional quality metrics. Sustained performance improvement at..."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer • HER-2

Racial and ethnic differences in site of metastasis at presentation and treatment in de novo metastatic triple-negative breast cancer (SABCS 2025) - "Immunotherapy use was restricted to patients treated with chemotherapy from 2019-2022, following the initial accelerated approvals for atezolizumab in 2019 and pembrolizumab in 2020 for metastatic TNBC. This NCDB study found notable racial/ethnic and socioeconomic disparities in metastases at presentation and treatment initiation delays among patients diagnosed with de novo metastatic TNBC the U.S. More effort is needed to alleviate these disparities and to improve care equity and treatment outcomes for all patients with metastatic TNBC."

Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A phase i/ii single-arm trial of azenosertib (zn-c3) combined with carboplatin and pembrolizumab in patients with metastatic triple-negative breast cancer (zap-it) (SABCS 2025) - "A phase II study assessing the efficacy of the WEE1 inhibitor adavosertib with cisplatin in 34 patients with mTNBC treated with 0-1 prior lines of chemotherapy showed an ORR of 26% (Keenan. A maximum of 78 patients will be enrolled. To our knowledge this is the first and only ongoing study testing the combination of a WEE1 inhibitor with carboplatin and a checkpoint inhibitor for the treatment of breast cancer."

Clinical • IO biomarker • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CDK1 • HER-2 • PD-L1 • WEE1

Digital health adherence companion study for tetrathiomolybdate (TM) plus capecitabine in triple-negative breast cancer (SABCS 2025) - P1/2 | "Patients will receive TM with capecitabine and pembrolizumab in 20 mg capsule increments, with daily doses up to 180 mg during the induction phase (first 6 months) and 100 mg during the maintenance phase (subsequent 30 months) in 28-day cycles. A multivariate regression analysis will be used to evaluate predictors of adherence. Clinical Trial Information: NCT06134375"

Adherence • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in patients with metastatic TNBC or HR+/HER2- MBC (START-002 trial) (SABCS 2025) - P1/2 | "Recent clinical results from the ASCENT-04 trial demonstrated improved progression-free survival in previously untreated PD-L1+ mTNBC patients who received the combination of SG and pembrolizumab, thus confirming the clinical potential of combining an ADC with an IO agent in metastatic breast cancer.START-002 explores the hypothesis that combining SG's immunomodulatory potential with invikafusp alfa's selective activation and expansion of tumor-reactive Vβ6/Vβ10 T-cells, will enhance anti-tumor responses and result in improved clinical outcomes in breast cancer patients.Study design: START-002 is a phase 1b/2 open label, multi-center study to determine the safety, feasibility, and anti-tumor activity of invikafusp alfa in combination with SG in patients with mTNBC or HR+/HER2- mBC. Prior topoisomerase 1 inhibitor therapy is excluded.Primary objective and endpoint: The primary objective of this Ph1b/2 study is to characterize the safety and tolerability of..."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Tumor mutational burden • Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer • CD8 • HER-2 • PD-L1 • TMB

Despatil study: a phase II trial of de-escalated neoadjuvant chemotherapy for early-stage triple-negative breast cancer guided by tumor-infiltrating lymphocytes (TILs) and radiologic response (SABCS 2025) - "Those without a radiologic complete response are escalated to four additional cycles of anthracycline and cyclophosphamide (AC), with or without pembrolizumab at the physician's discretion.Eligible participants are patients with HER2-negative invasive breast carcinoma, estrogen receptor and progesterone receptor expression <10%, and one of the following: (1) clinical stage T1c N0 M0 with any TIL level; or (2) clinical stage T2 N0 M0 with TILs ≥50%.A total of 40 patients will be enrolled.The primary endpoint is pathologic complete response (pCR) following four cycles of carboplatin and taxane. Secondary endpoints include the correlation between radiologic and pathologic response, residual cancer burden (RCB), event-free survival (EFS), overall survival (OS), and subgroup analyses by disease stage. Patient enrollment is expected to begin in the second half of 2025."

Clinical • P2 data • Tumor-infiltrating lymphocyte • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Trend-02 study - a phase ii exploratory de-escalation trial of neoadjuvant sacituzumab govitecan plus tislelizumab (sg/i) in early triple-negative breast cancer (SABCS 2025) - "The TREND trial previously reported that eight cycles of tislelizumab plus low-dose chemotherapy achieved a 68.18% pCR, while NeoSTAR showed four cycles of SG plus pembrolizumab yielded 32% pCR with reduced toxicity versus standard care. After surgery, patients achieving pCR will complete a total of one year of tislelizumab (q3w) treatment; non-pCR patients receive investigator-selected adjuvant therapy. The primary endpoint is pCR rate, with secondary endpoints including NACT rate, clinical response rate, adverse events, and EFS."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TACSTD2

Trofuse-011: a phase 3, randomized, open-label study of sacituzumab tirumotecan with or without pembrolizumab vs treatment of physician's choice for previously untreated locally recurrent unresectable or metastatic triple-negative breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; MK-2870/SKB264) is a novel antibody-drug conjugate (ADC) composed of an anti-trophoblast cell surface antigen 2 (TROP2) monoclonal antibody coupled to a cytotoxic belotecan derivative, topoisomerase I inhibitor payload via a novel linker. Tumor imaging occurs at baseline, Q8W after randomization until week 48, and Q12W thereafter. Enrollment is ongoing."

Clinical • IO biomarker • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

A phase 1b, multi-centre, open-label, randomized study to evaluate the safety, tolerability, and clinical activity of combining paxalisib with olaparib or pembrolizumab/chemotherapy in patients with advanced breast cancer (SABCS 2025) - P1 | "Patients will receive daily paxalisib (15 mg or 30 mg) in 21-day cycles, pembrolizumab (200 mg IV every 3 weeks), and standard-of-care chemotherapy (investigator's choice: nab-paclitaxel or gemcitabine-carboplatin). Clinical: Upcoming data will include updated liquid biopsy biomarker analyses, encompassing CTC enumeration and phenotyping, as well as profiling of immune cell exhaustion and reinvigoration signatures.ConclusionsOur preclinical studies demonstrated that combining paxalisib with either immunotherapy or PARP inhibition significantly reduced CTC burden and reshaped the immune landscape, leading to a decrease in metastasis. These promising findings have advanced into a Phase 1b clinical trial in patients with advanced breast cancer, with updated analysis to be presented at this meeting."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • CTCs • HER-2 • PD-L1 • PTPRC

Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: A Randomized Phase 2 Study of Tetrathiomolybdate (TM), an oral copper depletion agent plus capecitabine +/- pembrolizumab in patients with breast cancer at high risk of recurrence (NCT06134375). (SABCS 2025) - P1/2 | "We plan to enroll 186 pts in this study across 8 sites. The study is open and actively accruing since November 2024."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • KDR

Trial in progress: Phase 1 Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer (NCI Protocol #10546) (SABCS 2025) - " This is a phase 1, open-label, multicenter study evaluating the safety and recommended phase 2 dose (RP2D) of the oral DNMT inhibitor ASTX727 + paclitaxel + pembrolizumab in metastatic TNBC. Patients must have an ECOG performance status of ≤2 and have no gastrointestinal disorders impacting absorption of oral medications. As of June 20, 2025, the study is enrolling patients, with 10 patients dosed in the dose-finding phase."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • DNMT3A • HER-2 • PD-L1

Cappa, a phase 2 study to evaluate capecitabine plus pembrolizumab as post-operative adjuvant therapy for triple-negative breast cancer with residual disease after neoadjuvant chemo-immunotherapy (SABCS 2025) - "As of July 9, N=14 and 17 pts have been included in the experimental and external cohort, respectively. The inclusion period is expected to last 18 months."

Clinical • P2 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Opt-pembro: a phase III randomized trial of adjuvant pembrolizumab omission in patients with early-stage triple-negative breast cancer achieving pathologic complete response after neoadjuvant chemo-immunotherapy (SABCS 2025) - "OPT-PEMBRO is an international randomized trial to test the non-inferiority of omitting adjuvant immunotherapy in patients with eTNBC presenting pCR following standard neoadjuvant chemotherapy plus pembrolizumab. By targeting a good-prognosis population, it aims to personalize immunotherapy duration, reduce toxicity, preserve quality of life, and lower healthcare costs without compromising outcomes."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Toward optimization of treatment strategies for early breast cancer: a multicenter observational study integrating whole genome and transcriptome sequencing within the National Whole Genome Project in Japan (WJOG16822B) (SABCS 2025) - P=N/A | "In patients with early-stage triple-negative breast cancer (TNBC), the phase 3 KEYNOTE-522 trial showed significant improvement in overall survival (OS) with the addition of pembrolizumab to neoadjuvant chemotherapy...Enrollment began in December 2023, and 150 patients have been enrolled at the time of submission. Clinical trial information: jRCT1030250152"

Clinical • IO biomarker • Observational data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • GZMB • HER-2 • PD-L1 • PD-L2

Reframing Breast Cancer Therapies in a Rare Context - A Case of Metastatic Mammary-Like Vulvar Carcinoma Treated with Breast Cancer Regimens (SABCS 2025) - "She received adjuvant radiation with concurrent cisplatin. Given HER2 positivity, she was treated with six cycles of docetaxel, trastuzumab, and pertuzumab, followed by maintenance trastuzumab and pertuzumab...She was treated with olaparib from February to November 2023. Following disease progression, she transitioned to trastuzumab deruxtecan for HER2-low disease, which resulted in temporary disease control between December 2022 to May 2024. Upon further progression, she received carboplatin, paclitaxel, and bevacizumab, completing six cycles in May 2024, followed by maintenance bevacizumab and pembrolizumab... MLVA is an extremely rare malignancy with no established standards of care. Its histologic resemblance to breast cancer suggests it may respond to breast cancer-based therapies. In the absence of defined treatment pathways, applying breast cancer therapeutic strategies—particularly in the metastatic setting—may offer a rational and effective approach for managing..."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • BRCA2 • ER • GATA3 • HER-2 • PAX8 • PGR • SOX10

Autoimmune Hemolytic Anemia Triggered by Neoadjuvant Pembrolizumab in Triple Negative Breast Cancer: A Case Report (SABCS 2025) - "She completed four cycles of paclitaxel, carboplatin, and pembrolizumab with a good clinical response. The second cycle of doxorubicin and cyclophosphamide (AC) plus pembrolizumab was delayed due to neutropenic fever and symptomatic anemia (hemoglobin 7.1 g/dL)...The temporal association with pembrolizumab exposure and clinical resolution following its withdrawal and steroid therapy supports a diagnosis of pembrolizumab-induced AIHA. Clinicians should maintain a high index of suspicion since prompt recognition and treatment with corticosteroids is critical."

Case report • Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HP

A case of triple negative breast cancer in Lynch Syndrome (SABCS 2025) - "Case Presentation: Our patient is a 73-year-old woman with a past medical history of LS (MSH2 deletion), endometrial cancer status-post TAH/BSO, rectal cancer status-post abdominoperineal resection and end ileostomy, and colon cancer status-post right hemicolectomy/appendectomy and chemotherapy with 5-fluorouracil and leucovorin...Pembrolizumab was resumed. Adjuvant treatment with dose-reduced capecitabine was initiated following the CREATE-X trial...There are no treatment recommendations specific to LS patients with breast cancer. Larger prospective studies are warranted to establish a potential need for intensified breast cancer screening in patients with LS, as well as to study outcomes of breast cancer in LS patients."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • MLH1 • MSH2 • MSH6 • PMS2