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

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

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

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