Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor & who have progressed on a KRAS G12C inhibitor. The trial is expected to start at the […]Read More
Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, […]Read More
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver mutations The interim analysis met its 1EPs i.e., improvement in PFS, superior ORR & DoR, OS data are still maturing. The safety profile was consistent with PD-1 inhibitor while final […]Read More
Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone in 1013 patients with mNSCLC The results showed an improvement in OS & PFS, 28% reduction in risk of cancer progressing or death with an m-PFS (6.2 vs 4.8mos.), 23% […]Read More
Shots: The companies initiate P-III SANOVO study to evaluates the efficacy & safety of Orpathys in combination with AstraZeneca’s Tagrisso (irreversible EGFR TKI) vs Tagrisso alone in patients with NSCLC whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on Sept 7, 2021 The 1EPs of the study is m-PFS as […]Read More
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The results of the study will be presented at WCLC 2021 Results: improvement in PFS with m-PFS (8.3 vs 5.6mos.), m-OS (21.0 vs 16.0mos.). In sq. & nonsq. NSCLC patients – […]Read More
Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent platinum-based CRT in 235 centers across 26 countries The updated post-hoc analyses demonstrated OS @5yrs. (42.9% vs 33.4%), m-OS (47.5 vs 29.1mos); at the treatment course of one year patients […]Read More
Shots: The companies collaborated to develop a tissue based KRAS Cdx test to identify patients with cancers that have a KRASG12C mutation who may benefit from treatment with adagrasib, which is an investigational small molecule inhibitor of KRASG12 The agreement initially focuses on developing CDx for NSCLC and allows to further development of tests for […]Read More
Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment in patients with mNSCLC The study demonstrated improvement in OS and combination also showed improvement in PFS, as previously reported in Oct 2019. In a previous analysis, patients treated with […]Read More
Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: improvement in OS in people with high PD-L1 expression (20.2 vs 13.1mos.), safety was consistent with its known safety profile […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
