Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT Results: ORR (40%); […]Read More
Shots: The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors Results: ORR (57%) and CR rate (5.7%) […]Read More
Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or […]Read More
Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & […]Read More
Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic […]Read More
Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC with an EGFR exon 19 deletion or L858R mutation The dose-escalation part will assess the safety & tolerability of different dosing combinations of dual regimen to determine the recommended dose […]Read More
Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20 The 1EPs od the study will be ORR while the 2EPs include OS, PFS, PFS@6mos., one-year survival […]Read More
Shots: The NMPA has approved Byvasda for the treatment of patients with NSCLC and metastatic colorectal cancer. The approval follows TYVYT (sintilimab injection) approval, indicated to treat patients with Hodgkin’s lymphoma, granted in Dec’2018 The launch of Byvasda will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection In Jan’2020, Innovent granted […]Read More
Shots: The two companies divulged the results of ongoing P-II DESTINY-CRC01 study assessing Enhertu in patients with HER2+ unresectable and/or m-colorectal cancer, prior treated with 2L standard therapies. Results: ORR (45.3%); DCR (83.0%); PFS (6.9mos.); subgroup patients including patients with treated with a prior anti-HER2 regimen, ORR (43.8%) with a median treatment duration of 4.8mos. […]Read More
Shots: The P-III ALEX study involves assessing of Alecensa vs crizotinib in 303 treatment-naïve patients in a ratio (1:1) with ALK+ NSCLC whose tumors were characterized as ALK+ by the VENTANA ALK (D5F3) CDx Assay Updated results: OS @5yrs. (62.5% vs 45.5%); reduction in the risk of death in patients with/ without CNS metastases (42%/ […]Read More
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