RESUMEN
OBJECTIVE: :To compare efficacy and safety of a biosimilar, Bevacizumab (Hetero) vs reference medicinal product (Bevacizumab, Roche) as first line therapy in patients with metastatic colorectal cancer (mCRC) in combination with chemotherapy. METHODS: Patients of aged 18 to 65 with histologically pre-confirmed mCRC and treatment naïve with unresectable metastatic disease or distant metastases were enrolled and randomized to receive either Hetero-Bevacizumab or RMPBevacizumab along with chemotherapy (XELOX or FOLFOX-4) regimen over a period of 24 weeks (up to 8 cycles of Hetero-Bevacizumab/RMP-Bevacizumab+ XELOX regimen (each cycle of 3 weeks) or up to 12 cycles of Hetero-Bevacizumab/ RMP-Bevacizumab + FOLFOX-4 regimen (each cycle of 2 weeks). Bevacizumab was administered at 7.5 mg/kg as an IV infusion over 60-90 minutes on Day 1 of each treatment cycle. The efficacy endpoints were the overall response rate (CR+PR) and disease control rate (DCR) according to RECIST 1.1. The safety endpoints included assessments of treatment emergent adverse events and immunogenicity. RESULTS: 160 patients were screened; 111 patients were randomized in the study. No statistical significant difference in overall response rate between both the treatment groups (HB-MAB vs. RB-MAB: 35.56 % vs. 20%, P=0.28 at Week 6; 37.50 % vs. 30.77 %, P=0.73 at Week 12). Similar trend was observed for disease control rate (HB-MAB vs. RB-MAB: 100% vs. 96%, P=0.36 at Week 6; 95.83 vs. 100%, P=1.00 at Week 12). CONCLUSIONS: Herero's Bevacizumab was found to be comparable to reference medical product, Bevacizumab in terms of efficacy and tolerability for the Indian patients with metastatic colorectal cancer.
Asunto(s)
Antineoplásicos Inmunológicos/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Adolescente , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica , Biosimilares Farmacéuticos/uso terapéutico , Humanos , Persona de Mediana Edad , Compuestos Organoplatinos , Estudios Prospectivos , Adulto JovenRESUMEN
OBJECTIVE: To compare the antitumor efficacy, safety, and pharmacodynamics (PD) characteristics of Hetero-Rituximab (test) with Reference Medicinal Product (Rituximab, Roche) in Non-Hodgkin's Lymphoma (NHL). PATIENTS AND METHODS: Total 40 Follicular Lymphoma (FL) patients were randomized to receive intravenous infusion of either test or reference product. Efficacy (best overall response [BOR] rate [primary end point]), safety, PD (CD19), and immunological assessments (secondary end points) were done at the end of cycle 3 and cycle 6. RESULTS: Out of 40 patients randomized, 17 were in test arm while 23 were in reference arm. At the end of 6 cycles, BOR (complete response [CR] and partial response [PR]) rate was 64.71% (n=11) in Hetero Rituximab compared to the 43.48% (n=10) in reference arm. The difference between test and reference proportions of best overall response rate at cycle 6, lies within the pre-specified limit for noninferiority. Anti-Rituximab antibodies were found to be negative at cycle 3 and cycle 6 for all FL patients. The FL patients who were treated with Hetero Rituximab, showed significant depletion in CD19+ cell which was comparable with Reference drug. Safety and Immunogenic potential of the test drug was comparable to the reference drug in the patients of FL. CONCLUSION: Best overall response rate at Cycle 3, Cycle 6 and end of the study lies within the pre-specified limit for non-inferiority which concludes that test product is therapeutically non-inferior to reference medicinal product.