Pertuvia (pertuzumab biosimilar) / Biocad - LARVOL DELTA

Pharmacokinetics, safety, and immunogenicity of a biosimilar pertuzumab (BCD‑178) and reference pertuzumab in healthy subjects: results of a randomized, double-blind, comparative phase I clinical study (ESMO 2026) - No abstract available

Clinical • P1 data • PK/PD data • Oncology

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Minimal residual disease • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Efficacy and safety of the pertuzumab biosimilar BCD‑178 versus the originator pertuzumab in patients with HER2-positive locally advanced breast cancer: Results from the international, double-blind, randomized, phase III PREFER trial. (ASCO 2026) - P3 | "Patients were randomized 1:1 to receive neoadjuvant therapy with either BCD‑178 or OP, combined with trastuzumab and chemotherapy (TCHP regimen)... In patients with HER2+, hormone receptor-negative locally advanced breast cancer, the biosimilar BCD‑178 demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics to the originator pertuzumab within a neoadjuvant TCHP regimen."

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

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=190 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; Inadequate accrual rate

Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis (clinicaltrials.gov) - P3 | N=562 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

EAY131-J: Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center

Minimal residual disease • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=190 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2 | N=6452 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Biomarker • Trial completion date • Trial primary completion date • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hormone Receptor Positive Breast Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Uterine Cancer • CD4 • MSI

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=315 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

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

PREFER: Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=398 | Active, not recruiting | Sponsor: Biocad | Trial primary completion date: Jan 2024 ➔ Jun 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

The Ministry of Health has registered the first Russian equivalent of Roche’s pertuzumab (GxP News) - "Russia’s Ministry of Health has approved the country’s first domestic biosimilar of Roche’s Perjeta (pertuzumab) for HER2-positive breast cancer. The new drug, named Pertuvia and developed by Russian biotech firm Biocad, marks the country’s entry into locally produced biosimilars for this therapy....Biocad claims the biosimilar demonstrates comparable clinical performance to the original, including similar safety profile, pharmacokinetics, and immunogenicity."

Approval • HER2 Positive Breast Cancer

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=315 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2024 ➔ Dec 2025

Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=190 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=600 ➔ 190 | Trial completion date: Apr 2024 ➔ May 2025

Enrollment change • Metastases • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=315 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: National Cancer Institute (NCI) | N=12 ➔ 2 | Recruiting ➔ Terminated; Inadequate accrual rate

Combination therapy • Enrollment change • Metastases • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • PTEN

PREFER: Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=336 | Recruiting | Sponsor: Biocad

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Biocad

New P1 trial • Breast Cancer • Oncology • Solid Tumor