Hervycta (trastuzumab biosimilar) / Dr. Reddy’s - LARVOL DELTA

Pathologic complete response (pCR) of neoadjuvant therapy with or without atezolizumab in HER2-positive, early high-risk and locally advanced breast cancer: APTneo Michelangelo randomized trial (SABCS 2023) - P3 | "Background: Neoadjuvant dual targeting of HER2 with trastuzumab (H) and pertuzumab (P) plus chemotherapy is the standard of care for high-risk HER2-positive (HER2+) breast cancer (BC)... In this multicenter open label phase III trial (NCT03595592), 661 patients (pts) with high-risk early and locally advanced (LA) centrally confirmed HER2+ BC were randomized to neoadjuvant HPCT (H and P d1, carboplatin and paclitaxel iv d1 and 8) given q3 wks for 6 cycles w/o (n=223, ARM A) or with atezolizumab 1200 mg iv d1 (n=438, ARM B). In Arm B pts were randomized to Arm B1 (n=218) to receive anthracycline and cyclophosphamide (AC) + atezolizumab iv d1 q3 wks for 3 cycles followed by HPCT + atezolizumab for 3 cycles, or to arm B2 (n=220) to receive HPCT + atezolizumab for 6 cycles... Addition of atezolizumab to chemotherapy and HP did not significantly increase the rate of pCR in women with HER2+ BC. An exploratory analysis showed that adding atezolizumab to neoadjuvant AC..."

Clinical • Late-breaking abstract • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03 (SABCS 2022) - P3 | "Methods Pts with HER2+ mBC previously treated with trastuzumab and a taxane in either the metastatic setting or (neo)adjuvant setting with progression within 6 mo of therapy, who could have received pertuzumab, were randomly assigned 1:1 to receive T-DXd 5.4 mg/kg every 3 weeks (Q3W) or T-DM1 3.6 mg/kg Q3W until disease progression...Drug-related interstitial lung disease/pneumonitis, as evaluated by an independent adjudication committee, was experienced by 39 pts (15.2%) in the T-DXd arm and 8 pts (3.1%) in the T DM1 arm; no adjudicated drug-related grade 4 or 5 events were observed in pts who received T-DXd. Conclusions Updated results confirm the superiority of T-DXd compared with T-DM1 for pts with HER2+ mBC previously treated with an anti-HER2 therapy, with highly clinically meaningful and statistically significant benefit in OS and PFS and a manageable safety profile with longer treatment duration."

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

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

Interstitial lung disease risk and outcomes across HER2-targeted therapies commonly used in breast cancer: Analysis of real-world FAERS data. (ASCO 2026) - "The findings in this study highlight the trends of ILD among various HER2-targeted therapies. TDX-d demonstrated disproportionately lower hospitalization rates relative to the mortality burden compared to TDM-1 and Trastuzumab. This underscores the need for enhanced monitoring, early detection strategies, and lower thresholds for hospitalization in patients receiving TDX-d."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Clinical significance of achieving no evidence of disease in HER2-positive metastatic breast cancer: A multicenter study by Turkish Oncology Group (TOG) (ESMO-TAT 2026) - "Neither local therapies nor treatment regimen (trastuzumab vs. trastuzumab + pertuzumab) were associated with NED attainment or PFS. In this extensive multicenter cohort of long-term responders, nearly half of HER2-positive MBC patients achieved NED... In this extensive multicenter cohort of long-term responders, nearly half of HER2-positive MBC patients achieved NED. Notably, NED was the sole independent predictor of prolonged PFS, with durations exceeding 10 years. Favorable ECOG performance status, HER2 IHC 3+ expression and high tumor grade were strongly associated with achieving NED."

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

A Prospective, Single arm, Multicentre, Post-marketing Study (Phase IV) to evaluate effectiveness of Dr. Reddy’s Trastuzumab (DRL_TZ) in Patients with HER2-Positive Advanced Breast Cancer. (EBCC 2024) - "Patients received DRL_TZ (loading dose 8 mg/kg and 6 mg/kg for subsequent cycles) as a 3 weekly-regimen in combination with either paclitaxel or docetaxel for up to 8 cycles...Partial response was observed in 84 (51.9%) patients of HER2+ ABC (95 % CI: 43.88, 59.76). Conclusions : This PMS demonstrated real-world effectiveness of DRL_TZ in HER2+ ABC to be consistent with literature."

Clinical • Metastases • P4 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Prospective, Single arm, Multicentre, Post-marketing Study (Phase IV) to evaluate safety and immunogenicity of Dr. Reddy’s Trastuzumab (DRL_TZ) in Patients with HER2-Positive Advanced Breast Cancer (EBCC 2024) - "Patients received DRL_TZ (loading dose 8 mg/kg and 6 mg/kg for subsequent cycles q3w) in combination with either paclitaxel or docetaxel for up to 8 cycles...Confirmatory assay 2 for ADA was positive in 3(3.9%) patients (3.9%) at end-of-study and 1 (1.3%) patient was positive for neutralizing ADA; none had corresponding AE. Conclusion : This PMS demonstrated real-world safety & immunogenicity of DRL_TZ in HER2+ ABC to be consistent with literature."

Clinical • Metastases • P4 data • Alopecia • Anemia • Back Pain • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Infectious Disease • Musculoskeletal Pain • Nephrology • Novel Coronavirus Disease • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • HER-2

Efficacy, Safety, Pharmacokinetics, and Immunogenicity of DRL-Trastuzumab Versus Herceptin in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Randomized Controlled Trial. (PubMed, JCO Glob Oncol) - "DRL_TZ was found to have similar efficacy and comparable safety, PK, and immunogenicity profiles as the RMP."

Clinical • Journal • Metastases • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A randomized, double-blind, parallel-group, single-dose comparative pharmacokinetic study of DRL_TZ, a candidate biosimilar of trastuzumab, with Herceptin (EU) in healthy adult males. (PubMed, Indian J Med Res) - "Fifteen subjects, eight in DRL_TZ arm and seven in Herceptin arm, tested positive for anti-drug antibodies (ADAs), none of the ADAs were neutralizing in nature. : In this study, DRL_TZ demonstrated PK equivalence with the RMP and had comparable safety and immunogenicity profiles in healthy adult male subjects."

Clinical • Journal • PK/PD data • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dr. Reddy's Laboratories announces the launch of Hervycta (trastuzumab biosimilar) in India (Businesswire) - "Dr. Reddy’s Laboratories...announced today that it has launched Hervycta® (trastuzumab), a biosimilar of Roche’s Herceptin®, in India, indicated for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer)."

Biosimilar launch