Perjeta (pertuzumab) / Roche - LARVOL DELTA

Invited Discussant – Asian perspectives on DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC) (ESMO Asia 2025) - No abstract available

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC) (ESMO Asia 2025) - No abstract available

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of Asian patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC): A DESTINY-Breast09 analysis (ESMO Asia 2025) - P3 | "T-DXd + P demonstrated consistent efficacy as 1L treatment in Asian pts with HER2+ a/mBC, with no new safety signals. Table: 88MO Data in brackets are 95% CIs. *Estimate may change at updated analysis BICR, blinded independent central review; CI, confidence interval; DOR, duration of response; INV, investigator; mo, months; NC, not calculable; PFS, progression-free survival; ORR, objective response rate"

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

EMILIA and DESTINY: Real-World Sequencing Insights in a HER2-positive Metastatic Breast Cancer with Rare Pancreatic metastasis (ESMO Asia 2025) - "In an attempt to render her no evidence of disease (NED), MDT pursued mastectomy (ypTis) and chest wall radiotherapy, followed by maintenance trastuzumab pertuzumab 1 year...Gemcitabine bridging was administered during visceral crisis, after which trastuzumab emtansine (TDM-1) was commenced, achieving stable disease with marginal regression sustained over six cycles...Repeated biopsy was critical to exclude a second primary and reaffirm HER2 status, enabling optimal therapeutic choice. These observations support further investigation into post–T-DXd sequencing strategies and may inform management of biologically similar patient subgroups in ongoing and future trials."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor • ER • HER-2 • PGR

Preliminary efficacy and safety of TQB2102 in HER2-positive locally advanced unresectable or metastatic biliary tract cancer: Phase Ib study results (ESMO Asia 2025) - P1/2 | "Notably, in Cohort 1, the ORR was 28.6% (95% CI: 3.7–71.0) in pts with prior anti-HER2 therapy( Trastuzumab,Pertuzumab,DS-8201) and 50% (95% CI: 6.8–93.2) in HER2 IHC 2+ and ISH+ pts. TQB2102 demonstrated favorable tolerability and encouraging antitumor activity in HER2-positive locally advanced/metastatic BTC. The 7.5 mg/kg dose showed superior efficacy versus 6.0 mg/kg and is therefore recommended as the RP2D for BTC. The Phase 2 study is currently in preparation."

Clinical • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • CD4 • HER-2

HydroLock: A versatile ADC platform with robust plasma stability, excellent bystander killing and superior in vivo efficacy (ESMO Asia 2025) - "Efficacies of Herceptin-GSC4903 and the potential to overcome DS8201 resistance were determined...We also conjugate eribulin to pertuzumab (Pertuzumab-GSC4781)... All these results warrant HydroLock as a novel and promising linker-payload platform for ADC development. HydroLock was leveraged in several bispecific ADC programs and the first IND submission is expected in late 2025."

Preclinical • Oncology

HERTHENA-Breast01: A phase Ib/II, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ advanced breast cancer (BC) (ESMO Asia 2025) - P1/2 | "Background: Although HER2-targeted antibody-drug conjugates (ADCs) have improved outcomes in HER2+ advanced BC, safe and effective later-line therapies are needed for patients who have progressed on trastuzumab deruxtecan (T-DXd)...Pts in Arms 2 and 3 receive the same regimen as Arm 1, with either pertuzumab 840 mg IV followed by 420 mg IV Q3W (Arm 2) or tucatinib 300 mg orally BID (Arm 3)...Secondary endpoints are pharmacokinetics of HER3-DXd ADC, total HER3-DXd antidrug antibody and free DXd payload. Enrollment began in early 2025."

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-positive (HER2+) advanced breast cancer (ABC) with CNS progression after local treatment: Real-world data (ESMO Asia 2025) - "Median lines of previous treatment in ABC was four (1-8), 47 (84%) pts have received pertuzumab, T-DM1 – 45 (80%) pts, lapatinib – 22 (39%) pts; all 3 anti-HER2 Rx received 15 (27%)pts. T-DXd is effective even in pts with CNS progression previously treated with radiation therapy. No new safety signals were recorded."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world evaluation of a trastuzumab emtansine biosimilar in metastatic HER2-positive breast cancer: A single-centre retrospective analysis from India (ESMO Asia 2025) - "All patients had prior trastuzumab exposure; many were heavily pretreated (taxanes 84.3%, anthracyclines 62.7%, pertuzumab 19.6%, lapatinib 39.2%). This analysis supports the trastuzumab emtansine biosimilar as an effective, well-tolerated option for metastatic HER2-positive breast cancer, demonstrating a meaningful ORR and manageable toxicity profile, with PFS broadly consistent across subgroups. Confirmation in larger studies is warranted."

HEOR • Metastases • Real-world • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Pertuzumab versus pyrotinib in combination with trastuzumab and taxanes for first-line (1L) treatment of patients with HER2–positive metastatic breast cancer (HER2+MBC): A multicenter real-world study (ESMO Asia 2025) - "Background: The CLEOPATRA study established taxane+trastuzumab+pertuzumab(THP)as the 1L standard for HER2+ MBC over a decade ago. The recent PHILA study showed that docetaxel+trastuzumab+pyrotinib (an irreversible pan-HER receptor tyrosine kinase inhibitor ) (THPy) significantly prolonged progression-free survival (PFS)versus placebo group, establishing it as a viable 1L option in China.Given limited comparative evidence, this real-world study aimed to evaluate the effectiveness of THP and THPy in HER2+ MBC patients and identify potential beneficiary populations for each regimen. Patients who were treated with THP or THPy as a 1L treatment between January 2018 and March 2025 were included in this multicenter real-world study... Compared with the THP ,THPy significantly improved PFS in patients with untreated HER2+MBC. Notably, THPy demonstrated superior survival benefits specifically in subgroups with:premenopausal status, ECOG PS 0, de novo stage IV disease, previous..."

Clinical • Combination therapy • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

The impact of primary prophylaxis with empegfilgrastim (long-acting G-CSF) on pathological complete response (pCR) during TCHP in early HER2+ breast cancer patients (ESMO Asia 2025) - P=N/A | "One of the most effective regimens – TCHP (docetaxel, carboplatin, trasruzumab, pertuzumab) requires primary G-CSF prophylaxis (PP). This analysis suggests that primary empegfilgrastim (long-acting G-CSF) prophylaxis has significant pCR benefit in comparison to filgrastim after the neoadjuvant TCHP in early HER2+ breast cancer pts. Further studies may help estimate the effect in subgroups more precisely."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

Impact of neoadjuvant TCHP dose intensity on pathological complete response in early HER2+ breast cancer: A Saudi retrospective study (ESMO Asia 2025) - "This study evaluated the impact of neoadjuvant TCHP DI (docetaxel, carboplatin, trastuzumab, pertuzumab) on pCR in early-stage HER2-positive breast cancer...Switching to paclitaxel showed a non-significant reduction in pCR (OR 0.26; p=0.107). DI reductions were common... DI reductions were common. While DI ≥0.85 was associated with numerically higher pCR, only carboplatin DI independently predicted pCR. HR positivity and docetaxel substitution were linked to lower pCR odds."

Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Utilization of neoadjuvant therapy for stage II-III HER2-positive breast cancer in Vietnam: A 10-year analysis on 2390 patients (ESMO Asia 2025) - "The rate of NAT utilization was significantly higher after pertuzumab and T-DM1 approval for early breast cancer (eBC), as well as after the increase in national health insurance coverage for trastuzumab from 50% to 60% in Vietnam: 19.2% vs. 34.7%, 28.8% vs. 53.2%, and 19.4% vs. 35.8% respectively, p values <0.001. Although NAT has been increasingly implemented, a significant proportion of patients were still treated with upfront surgery. There should be policies to increase patients' affordability to anti-HER2 therapies, and to improve multidisciplinary collaboration between breast surgeons and medical oncologists to ensure access to standard neoadjuvant therapy in Vietnam."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

The PHERGuide study demonstrates the utility of circulating tumor DNA for the early detection and real-time monitoring of localized HER2+ breast cancer (PRNewswire) - "With more than 250 samples analyzed, the results show a direct association between the levels of ctDNA in blood at the start of the study and the stage of the disease. Furthermore, this study also reveals a significant correlation between ctDNA and the response to treatment. After two cycles of therapy, an elimination of ctDNA was observed in 75% of the patients; before surgery, these values reached a negativization of 83%."

P2 data • HER2 Positive Breast Cancer

A serum biomarker panel for early detection of treatment-related cardiotoxicity in early HER2-positive breast cancer patients. (PubMed, Ann Med Surg (Lond)) - "All enrolled patients received the full treatment protocol consisting of anthracycline followed by 12 months of trastuzumab alone or with pertuzumab. The highest risk was observed when both elevated hs-Tn I (≥82 ng/L after four cycles of anti-HER2 agents) and elevated hs-CRP (after four cycles of anthracyclines) were present. The interaction between both hs-Tn I and hs-CRP demonstrates significant predictive value for cardiotoxicity risk related to HER2+ breast cancer treatment."

Biomarker • Journal • Breast Cancer • Cardiovascular • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IL6

Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): final results from DESTINY-Breast07 (SABCS 2025) - P1/2 | "In this Phase 1b/2 DESTINY-Breast07 study, safety profiles for T-DXd and pertuzumab were generally consistent with the known profiles of each agent. Encouraging clinical activity was demonstrated in pts who received either T-DXd monotherapy or T-DXd + pertuzumab as a 1L treatment for HER2+ mBC; results from the T-DXd + pertuzumab module are consistent with the interim findings from the Phase 3 DESTINY-Breast09 study."

Clinical • IO biomarker • Metastases • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • PGR

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

Unexpected B-hCG elevation in metastatic inflammatory breast cancer: A diagnostic dilemma (SABCS 2025) - "She progressed through several lines of therapy, including docetaxel, trastuzumab, and pertuzumab, dose dense doxorubicin and cyclophosphamide, and fam-trastuzumab deruxtecan. She is currently on therapy with tucatinib, capecitabine, and trastuzumab... In summary, this case highlights an instance of moderately elevated B-hCG in a patient with metastatic inflammatory breast cancer, which has not been well described in the literature to our knowledge. We sought to describe this case to alert providers to the possibility of false pregnancy tests in patients with breast cancer with no other known gynecological cancer. As with this patient, next steps include measurement of estradiol and FSH to confirm a post-menopausal state."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy of second- or third-line Tucatinib, Trastuzumab, and Capecitabine (TTC) following trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer: A multicenter French cohort study. (SABCS 2025) - "Prior (neo)adjuvant chemotherapy and anti-HER2 therapy were administered to 55.3% of patients, while 88.3% had received pertuzumab as treatment for metastatic disease. In this multicenter French cohort, TTC showed clinically meaningful activity as a second- or third-line therapy in HER2-positive MBC patients previously treated with T-DXd, especially among long-responders (PFS>18 months) to T-DXd. Final updated results will be presented at the meeting."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of neoadjuvant trastuzumab deruxtecan versus standard of care chemotherapy plus trastuzumab plus pertuzumab in HER2+ early breast cancer: WSG-ADAPT-HER2-IV [WITHDRAWN] (SABCS 2025) - No abstract available

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

Cardiac Monitoring in Patients Receiving HER2-Directed Therapy: A Meta-Analysis and Cost-Effectiveness Analysis (SABCS 2025) - "We conducted a meta-analysis to quantify the risk of cardiotoxicity associated with HER2-directed agents and developed a cost-effectiveness model to evaluate alternative frequency of cardiac monitoring in patients with a standard cardiovascular risk profile. We performed a systematic literature search (Ovid MEDLINE, Embase, Cochrane) and included 55 studies (n=39,335) evaluating trastuzumab, pertuzumab, trastuzumab deruxtecan (T-DXd), and trastuzumab emtansine (T-DM1). HER2-directed therapies are associated with low rates of symptomatic cardiotoxicity, particularly T-DM1 and T-DXd. Cost-effectiveness modeling demonstrated diminishing returns with more frequent LVEF monitoring. Future analyses will assess the cost-effectiveness of LVEF monitoring strategies in patients with early-stage or metastatic disease treated with trastuzumab, T-DM1, or T-DXd."

Cost effectiveness • HEOR • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer

Clinical predictors for first-line treatment duration in HER2-positive metastatic breast cancer Results from the AGMT_MBC-Registry (SABCS 2025) - "Background: Based upon the CLEOPATRA trial, a combination of docetaxel plus trastuzumab and pertuzumab (THP) has been the standard treatment for patients with metastatic HER2-positive breast cancer. This real-world analysis identified distinct clinical subgroups of patients with HER2-positive MBC who are at low risk for early 1L treatment discontinuation under the current standard CLEOPATRA regimen. The proposed risk model enables prognostic stratification and may help identify patients who do or do not need an alternative 1L approach, such as T-DXd-based combinations. External validation of the score in independent cohorts is warranted."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Patient-reported outcomes (PROs) in DESTINY-Breast11: neoadjuvant treatment (NAT) with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer (eBC) (SABCS 2025) - "More patients had maintained or improved PF with T-DXd or T-DXd-THP vs ddAC-THP. T-DXd and T-DXd-THP demonstrated a lower patient-reported treatment burden (tolerability, symptomatic AEs) than ddAC-THP. These findings, together with the favorable safety and efficacy profile of T-DXd-THP vs ddAC-THP, support T-DXd-THP as a tolerable therapy in high-risk HER2+ eBC.Table."

Clinical • Patient reported outcomes • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

MODULE 2: Previously Untreated HER2-Positive Metastatic Breast Cancer (mBC) (SABCS 2025) - "Sponsored by AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Puma Biotechnology Inc. Historical outcomes with standard HER2-targeted therapies for newly diagnosed HER2-positive mBC; rationale for the evaluation of effective later-line HER2-targeted treatments in the front-line setting Early data with T-DXd in combination with pertuzumab as up-front therapy for HER2-positive mBC in the Phase Ib/II DESTINY-Breast07 study Published efficacy and safety findings from the Phase III DESTINY-Breast09 trial documenting the benefit of T-DXd in combination with pertuzumab versus taxane/trastuzumab/pertuzumab as first-line therapy for HER2-positive mBC Emerging positive findings from the Phase III HER2CLIMB-05 study assessing tucatinib versus placebo, both in combination with standard first-line maintenance therapy, after chemotherapy-based induction for HER2-positive mBC"

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world Clinical Outcomes in Patients with HER2+ Metastatic Breast Cancer Treated with Trastuzumab Deruxtecan After One or More Prior Lines of Therapy: Data from U.S Community Oncology Practices (SABCS 2025) - "Clinical outcomes of 1L and 2L rwTTF were examined in an exploratory subgroup of pts with 1L taxane+trastuzumab+pertuzumab based regimen (THP) followed by 2L T-DXd vs. 2L trastuzumab emtansine (T-DM1). The study findings affirm the real-world clinical effectiveness and safety of T-DXd in pts with HER2+ mBC as observed in the DESTINY clinical trials. Despite higher disease and comorbidity burden in this small sample of pts with 2L T-DXd use, longer delays in time to progression and discontinuation were observed compared to later line use of T-DXd; and longer rwTTF compared to 2L T-DM1 use, reinforcing the importance of utilizing T-DXd as early as possible in the treatment pathway to improve long-term pt outcomes."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2