Perjeta (pertuzumab) / Roche - LARVOL DELTA

Pharmacokinetic bioequivalence of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using a handheld syringe or an on-body delivery system. (PubMed, J Cancer Res Clin Oncol) - P1 | "This study demonstrated the feasibility of a hands-free device approach to deliver pertuzumab and trastuzumab in one fixed-dose combination for subcutaneous injection without compromising pharmacokinetics and safety."

Clinical • Journal • PK/PD data

Medicare spending and use of subcutaneous biologic formulations with hyaluronidase. (PubMed, Oncologist) - "For 4 of these drugs, hyaluronidase versions accounted for 5%-83% of Medicare spending in 2022, with hyaluronidase versions accounting for the highest share of spending for pertuzumab-trastuzumab and daratumumab and a lower share of spending for 2 drugs that had biosimilar competition for the original versions: rituximab and trastuzumab. The benefits of subcutaneous hyaluronidase versions must be balanced against the challenges that come with higher prices if these versions are introduced before biosimilar competition begins for the original versions. Policymakers should ensure manufacturers cannot use "hyaluronidase hopping" to delay biosimilar competition or eligibility for Medicare price negotiation."

Journal • Medicare • Reimbursement • US reimbursement

Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting. (PubMed, Front Oncol) - "Patients treated with first-line regimens benefited the most, with a median PFS of 15.0 versus (vs.) 10.0 months (first-line- vs. second-line inetetamab plus pyrotinib, p <0.001), 19.0 vs. 17.0 months (first-line- vs. second-line inetetamab plus pertuzumab, p=0.096), and 13.0 vs. not reached months (first-line- vs. second-line inetetamab plus chemotherapy, p=0.229). Diarrhea (39.2%), white blood cell count decreased (33.0%), and myelosuppression (18.6%) as the most frequent ones. Following the first- and second-line of treatment, inetetamab- containing combinations demonstrated promising clinical activity and a manageable safety profile in patients with HER2-positive MBC, especially in the first-line treatment."

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

ctDNA Analysis in ERBB2-Amplified Colorectal Cancer: Biomarker Analysis of the MyPathway Trial. (PubMed, Clin Cancer Res) - "A combination of two HER2-directed antibodies, pertuzumab and trastuzumab (P + T), has antitumor activity in HER2-positive colorectal cancer. ctDNA can detect ERBB2 amplification in many, but not all, patients with ERBB2 amplification detected in tumor samples. ctDNA molecular response was associated with better survival, and ctDNA co-alterations may offer insights into mechanisms of intrinsic and acquired resistance."

Biomarker • Circulating tumor DNA • Journal • Colorectal Cancer • Oncology • Solid Tumor • CDKN2A • HER-2 • KRAS • PIK3CA

Theranostic Pair of Affibody Molecules Targeting HER2 Expressing Cancer (SNMMI 2025) - "The theranostic pair targets a different HER2 epitope compared to trastuzumab or pertuzumab, allowing them to be administered concomitantly. Tezatabep matraxetan has demonstrated clinical utility in early trials with breast cancer patients, underscoring the unmet need for improved diagnostics that overcome the limitations of biopsy-based HER2 analysis. In preclinical studies, [177Lu]Lu-ABY-271 demonstrated a favorable biodistribution profile and potent antitumor effect, which was further enhanced when combined with trastuzumab. A first-in-human study of [177Lu]Lu-ABY-271 is currently under way with early results anticipated during 2025."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

A Pretargeted Immuno-PET imaging for Monitoring Human Epidermal Growth Factor Receptor 2 Expression Based on Bioorthogonal Diels-Alder Click Chemistry (SNMMI 2025) - "Both pretargeting strategies, Pertuzumab-TCO/18F-PEG12-Tz and Trastuzumab-TCO/18F-PEG12-Tz, achieved high-contrast images at 72 h after Pertuzumab-TCO or Trastuzumab-TCO administration, but Pertuzumab-TCO/18F-PEG12-Tz showed higher tumor-to-muscle ratios (25.40 vs 20.03) and lower background accumulation than Trastuzumab-TCO/18F-PEG12-Tz. Conclusion : High-contrast PET images obtained using the pretargeting strategy with Pertuzumab-TCO/18F-PEG12-Tz and Trastuzumab-TCO/18F-PEG12-Tz in SKOV-3 model mice indicate that the pretargeting imaging strategy with short half-life radionuclide labeled radioligands can greatly shorten the imaging time point and thus reduce the radiation dose of normal tissues.The Pretargeted strategy is a powerful tool for evaluating the expression of HER2 in tumor mice and a promising candidate for clinical transformation."

Oncology • HER-2

Theranostic Pair of Affibody Molecules Targeting HER2 Expressing Cancer (SNMMI 2025) - "The theranostic pair targets a different HER2 epitope compared to trastuzumab or pertuzumab, allowing them to be administered concomitantly. Tezatabep matraxetan has demonstrated clinical utility in early trials with breast cancer patients, underscoring the unmet need for improved diagnostics that overcome the limitations of biopsy-based HER2 analysis. In preclinical studies, [177Lu]Lu-ABY-271 demonstrated a favorable biodistribution profile and potent antitumor effect, which was further enhanced when combined with trastuzumab. A first-in-human study of [177Lu]Lu-ABY-271 is currently under way with early results anticipated during 2025."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Long and short-term efficacy and safety comparison of nab-paclitaxel versus paclitaxel combined with trastuzumab and pertuzumab for neoadjuvant treatment of HER2-positive breast cancer: A systematic review and meta-analysis. (PubMed, Cancer Treat Rev) - "Nab-paclitaxel exhibits short-term efficacy advantages over paclitaxel, but no significant long-term benefits. The two regimens have different safety profile."

Journal • Retrospective data • Review • Allergy • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • Thrombocytopenia • HER-2

Safety and efficacy of neoadjuvant disitamab vedotin in combination with pertuzumab with or without toripalimab for HER2-positive breast cancer: An open-label phase II trial. (ASCO 2025) - P2 | "The combination of disitamab vedotin, pertuzumab and toripalimab showed promising antitumor activity and manageable safety profiles. This regimen may offer a potential chemotherapy-free treatment option for patients in this population. The synergistic effects between HER2-directed antibody-drug conjugates (ADCs), immune checkpoint inhibitors and HER2-directed monoclonal antibodies are worthy of further exploration."

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

A Randomized Phase 2 Study of Neratinib With or Without Fulvestrant for Patients With HER2-Positive, Estrogen Receptor-Positive Metastatic Breast Cancer. (PubMed, Clin Breast Cancer) - "The combination of neratinib and fulvestrant is safe and tolerable. Due to early study closure, this study was underpowered to detect the benefit of adding fulvestrant to neratinib. Chemotherapy-free regimens targeting ER and HER2 warrant further investigation, along with prospective studies investigating ctDNA dynamics may guide treatment switch."

Journal • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Advancing Neoadjuvant Therapy with Inetetamab for HER2-Positive Breast Cancer. (PubMed, Cancer Lett) - "Although HER2-targeted therapies such as trastuzumab and pertuzumab result in significantly improved clinical outcomes, the total pathological complete response (tpCR) rate remains suboptimal, particularly among hormone receptor (HR)-positive patients [2]. In this issue of Cancer Letters, Zuo and colleagues present findings from a single-arm, multicenter phase II clinical trial investigating a neoadjuvant regimen combining inetetamab, pertuzumab, and nab-paclitaxel (TIP regimen) in patients with early-stage or locally advanced HER2-positive breast cancer [5]. Through comprehensive evaluation of both efficacy and safety, the study demonstrates exceptional therapeutic potential of the TIP regimen, with a high tpCR rate observed in estrogen receptor (ER)-negative patients, indicating particular promise for this subgroup of HER2-positive breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Spatial discovery of pyrotinib overcoming HER2-positive breast cancer resistance by breaking fibroblast-induced immune barriers. (PubMed, Drug Resist Updat) - "Spatial organization of cellular interactions in the tumor microenvironment (TME) provides insights into prognosis beyond pathological subtypes. The role of NeoPICD in disruption of fibroblast barriers and enhancement of immune cell function suggests therapeutic advantages in overcoming resistance to anti-HER2 therapies. This research offers new strategies for precision treatment of locally advanced HER2-positive breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Trastuzumab combined with Pertuzumab for Neoadjuvant Treatment of HER2-Positive Breast Cancer: A National Multi-Center Real-World Study (ChiCTR) - P=N/A | N=83 | Completed | Sponsor: The First Affiliated Hospital of Army Medical University; The First Affiliated Hospital of Army Military Medical University

New trial • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

An open, randomized controlled study comparing pyrotinib combined with trastuzumab and docetaxel (THPy) with trastuzumab combined with pertuzumab and docetaxel (THP) as first-line treatment for HER2-positive advanced breast cancer previously treated with trastuzumab combined with pertuzumab (HP) or trastuzumab (H). (ChiCTR) - P4 | N=490 | Not yet recruiting | Sponsor: Anhui Provincial Cancer Hospital; Anhui Provincial Cancer Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - P2 | N=528 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2024

Trial completion • Trial completion date • Oncology

The impact of ethnicity on benefit from novel drugs approved for breast cancer treatment: a systematic review and meta-analysis of randomized phase 3 trials of the last decade. (SABCS 2024) - "23 phase III RCTs were identified in the aBC setting, with 1547 (11.1%) patients of Asian ethnicity. Experimental drugs tested included CDK4/6i (palbociclib, ribociclib, abemaciclib), SERD (elacestrant), PI3Ki (alpelisib), PARPi (olaparib, talazoparib), broad variety of anti-HER2 drugs (tucatinib, trastuzumab deruxtecan, pertuzumab, T-DM1, neratinib, margetuximab), anti-PD-1 and anti-PD-L1 drugs (pembrolizumab, atezolizumab) and anti-TROP2 drug (sacituzumab govitecan). 16 RCTs provided HR (95%CI) for PFS in the subgroup of Asians and 17 RCTs for Non-Asians."

IO biomarker • P3 data • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Continuous glucose monitoring to characterize hyperglycemia during chemotherapy for early stage breast cancer. (PubMed, Breast Cancer Res Treat) - P | "All patients receiving chemotherapy for ESBC experienced hyperglycemia, with time spent hyperglycemic varying significantly by baseline A1c. Future research should explore approaches to and benefits of improving glycemic control during treatment in patients with baseline dysglycemia."

Journal • Breast Cancer • Diabetes • Fatigue • Metabolic Disorders • Oncology • Pain • Solid Tumor

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. (ASCO 2025) - P3 | "T-DXd + P demonstrated a statistically significant and clinically meaningful improvement in PFS vs THP that was consistently observed across all subgroups and may represent a new 1L standard of care in HER2+ a/mBC; no new safety signals were identified. NC, not calculable."

Clinical • Late-breaking abstract • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammation • Interstitial Lung Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2 • PIK3CA

Patterns of cardiac monitoring and outcomes in patients with HER2-positive breast cancer treated with a trastuzumab-based regimen in a safety-net system. (ASCO 2025) - "100% of patients received trastuzumab, and 63 (83%) received dual anti-HER2 therapy (trastuzumab-pertuzumab). Within our safety-net system, nearly half of our patient population did not receive baseline TTE screening prior to receiving cardiotoxic chemotherapy. As sociodemographic factors were not significantly associated with this outcome, there may be larger system-level barriers towards obtaining proper screening. Establishing a dedicated cardio-oncology department and recruiting dedicated technicians in oncology clinics may enhance adherence to recommended screening guidelines."

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

Real-World Data Analysis of Anti-HER2 Therapy–Induced Cardiotoxicity in Breast Cancer Patients: A Multi-Center Experience from the Middle East. (ASCO 2025) - "The most frequent treatment regimen consisted of dual HER2 inhibitors; trastuzumab and pertuzumab (62.8%). This real-world study demonstrates a manageable rate of cardiotoxicity in HER2-positive breast cancer patients receiving HER-2 inhibitors-based therapies in Saudi Arabia. Early detection and close monitoring with cardiology specialists are essential for timely intervention and optimal patient outcomes."

Clinical • Real-world • Real-world evidence • Breast Cancer • Cardiovascular • Diabetes • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertension • Metabolic Disorders • Oncology • Solid Tumor

Tumor-agnostic therapies in a high-volume Brazilian center: Real-world challenges and opportunities. (ASCO 2025) - "Forty pts (24%) received TAT: 37% checkpoint inhibitors, 12.5% Trastuzumab deruxtecan, 7.5% trastuzumab plus pertuzumab, crizotinib and sotorasib, 5% dabrafenib plus trametinib and 23% others. In this real-world retrospective analysis of a high-volume Latin American center, CGP enabled the identification of agnostic biomarkers, offering targeted therapeutic options and improved outcomes for select individuals. The analysis was limited by unmatched distribution of tumor types, lacking treatment history and comorbidities among groups. Limited access to TAT may reflect the timing of tests, pre-dating some agnostic approvals, as well as the high cost and restricted availability of these therapies."

Clinical • Pan tumor • Real-world • Real-world evidence • Tumor mutational burden • Lung Cancer • Microsatellite Instability • Oncology • Solid Tumor • ALK • BRAF • FGFR • HER-2 • KRAS • MSI • NRG1 • NTRK • TMB

Brain metastasis in patients with primary gastrointestinal malignancy on anti-HER2 therapy. (ASCO 2025) - " Out of 83,329 patients with gastrointestinal cancers, HER2 testing was performed on 13,153 individuals, identifying HER2 positivity or ERBB2 amplification in 571 patients: 49% with gastroesophageal cancer, 37% with colorectal cancer, 11.5% with Biliary tract cancers, 1% with appendiceal cancer, 0.8% with small intestinal cancer, and 0.7% with anal cancer The cohort of 571 patients comprised 68% males (387 patients) and 32% females (184 patients), with a median age at diagnosis of 58 years (range 21–89 years).Among the 177 patients receiving anti-HER2 therapy, (trastuzumab and pertuzumab or trastuzumab deruxtecan) 33 (18%) developed brain metastasis, while 20 (5%) of the 396 patients not receiving anti-HER2 therapy developed brain metastasis, p < 0.001 (RR = 3.7). These findings suggest a significantly higher incidence of brain metastasis in patients treated with anti-HER2 therapy (18%) compared to those who did not receive this treatment (5%). These findings..."

Clinical • Anal Carcinoma • Appendix Cancer • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor

Efficacy of trastuzumab and trastuzumab adjunct chemotherapy HER2 amplified colorectal cancer: A systematic review and meta-analysis. (ASCO 2025) - "The most effective chemotherapeutic combination was Trastuzumab and Lapatinib with an ORR of 0.80 (0.64; 0.90) and the safest one was Pertuzumab and Trastuzumab with a pooled proportion of adverse events of 0.20 (0.12; 0.32). The potential of HER2 as a target for cancer therapeutics remains far from fully realised, especially in CRC due to its lower incidence. Our study brings to light a significant improvement in survival rates of HER2-amplified advanced CRC with adjuvant trastuzumab therapy.These findings underscore the need for integration of HER2-targeted therapy into existing treatment protocols for appropriate cases to further improve patient outcomes."

Retrospective data • Review • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2

Pyrotinib in the first-line treatment of HER2-positive advanced breast cancer: Results from the PRETTY study. (ASCO 2025) - P=N/A | "In trastuzumab-treated patients, the median rwPFS was 19.9 months (95% CI, 17.1-22.7), and in trastuzumab-pertuzumab-treated patients, the median rwPFS was 24.9 months (95% CI, NR-NR). In real world, patients who received first-line pyrotinib-trastuzumab-based regimens achieved favorable effectiveness. With the continuous development of anti-HER2 therapy in the early stage, further exploration of pyrotinib-based regimens in the first-line treatment of HER2-positive advanced breast cancer is warranted."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • EGFR • ERBB4 • HER-2

A randomized, double-blind, three-arm, parallel group, phase 1 study to assess the pharmacokinetics, safety, and tolerability of PERT-IJS following a single dose of 420 mg intravenous infusion compared to the EU- and US-marketed drug product (pertuzumab; PERT) in healthy male volunteers. (ASCO 2025) - "This study demonstrated PK bioequivalence as well as comparable safety, tolerability, and immunogenicity between PERT-IJS versus EU-PERT/US-PERT and EU-PERT versus US-PERT in healthy male subjects. Statistical results of pertuzumab pharmacokinetics parameters"

Clinical • P1 data • PK/PD data • Breast Cancer • Oncology • Solid Tumor