Category: 2L

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

2L, Advanced, Clinical Trials, Innovent, Lilly, Metastatic, P-II ORIENT-3 Trial, Present, results, Sintilimab, Squamous Non-Small Cell Lung Cancer, Treatment, Tyvyt / April 14, 2021 April 14, 2021

Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25 mos.), mPFS (4.30 vs 2.79 mos.), ORR (25.5% vs 2.2%), …

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021 Read More »

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

1L, 2L, Advanced Non-Small Cell Lung Cancer, ALK+, Alunbrig (brigatinib), approval, MHLW, receives, regulatory, Takeda, Treatment / January 22, 2021 January 22, 2021

Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor The therapy showed effectiveness …

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Read More »

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

2L, approval, BeiGene, cHL, Classical Hodgkin Lymphoma, NMPA, receives, regulatory, Tislelizumab, Treatment / December 31, 2019 December 31, 2019

Shots: The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also …

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL) Read More »