Tags : P-III Trial

Biosimilars

EirGenix Report Results of EG12014 (biosimilar, trastuzumab) in P-III Trial

Shots: The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a […]Read More

Clinical Trials

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA

Shots: The P-III LIBERTY ASTHMA VOYAGE study involves assessing of Dupixent (SC, 100/200mg, q2w ) + SOC maintenance therapy of medium-dose ICS with a second controller medication/ high-dose ICS with/out second controller medication vs PBO in 408 children 6 to <12 years old with uncontrolled moderate-severe asthma Results: Patients with baseline blood EOS ≥300 cells/μl […]Read More

Biosimilars

Bio-Thera Reports Results of BAT1706 (biosimilar, bevacizumab) in P-III Trial

Shots: The P-III study involves assessing of BAT1706 vs EU Avastin (bevacizumab) + chemotherapy in patients with non-squamous NSCLC, evaluating its safety, efficacy, PK & immunogenicity The trial resulted in meeting its 1EPs and demonstrated the equivalence in ORR for 1L patients with advanced non-squamous NSCLC BAT1706 is mAb & second biosimilar in Bio-Thera’s portfolio […]Read More

Biosimilars

Dr. Reddy Plans the Onset of P-III trial for DRL_RI

Shots: The P-III trial involves assessing of DRL_RI vs Roche’s MabThera (rituximab) in 284 patients including 26 Koreans, with stage II-IV, CD20 positive, and follicular lymphoma previously treated have low tumor burden, evaluating its efficacy, safety, and immunogenicity Dr. Reddy’s plan to evaluate DRL_RI in Korea while Paraxel to provide clinical research services and Korea’s […]Read More