pertuzumab biosimilar / Intas - LARVOL DELTA

Efficacy, safety, and immunogenicity of pertuzumab biosimilar versus reference pertuzumab in combination with trastuzumab and docetaxel in HER2-positive metastatic breast cancer: A randomized, double-blind, multicenter, parallel group, phase III clinical trial. (ASCO 2026) - "Pertuzumab biosimilar demonstrated therapeutic equivalence to reference product in combination with trastuzumab and docetaxel for first-line HER2-positive MBC. Efficacy, safety, pharmacokinetic similarity, and comparable immunogenicity support biosimilarity and its potential as an effective treatment option. Summary statistics for objective response rate (ORR) at week 24 (mITT set, N=204)."

Clinical • Combination therapy • Metastases • P3 data • Alopecia • Breast Cancer • Cough • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Leukopenia • Neutropenia • Oncology • Respiratory Diseases • Solid Tumor • HER-2

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer (Medical Dialogues) - "Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase III clinical trial for its biosimilar of the anti-cancer drug Pertuzumab. The approval follows the company’s presentation of a protocol for a Phase III study titled: 'A Prospective, Randomized, Double-Blind, Parallel-Arm, Comparative, Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Pertuzumab Biosimilar of Intas Pharmaceuticals Limited Against Perjeta in Adult Patients with HER2-Positive Hormone Receptor-Negative Locally Advanced or Early Breast Cancer', submitted for export purposes under Protocol No. 0508-23, Version 1.0, dated 18 Oct 2024."

New P3 trial • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer