Tags : P-III

Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program

Shots: The pivotal P-III clinical program for tapinarof in adult with PsO consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) PSOARING 3 (NCT04053387), an ongoing long-term safety study. Positive results of P-III studies were reported in Aug’2020 Tapinarof previously met the 1EP in separate P-IIb trials for PsO & AD, both studies were published […]Read More

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for

Shots: The two studies of AZD7442 will enroll ~6,000 adults for the prevention of COVID-19 in and outside the US, expected to begin in next wk. with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections. The first study will evaluate the safety and efficacy of AZD7442 to prevent infection for up to […]Read More

BMS Report Results of Opdivo (nivolumab) + CT in P-III

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results mark the first time an immune checkpoint […]Read More

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc

Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%), defined as the presence of intra-retinal fluid or subretinal fluid […]Read More

Neurocrine Presents New Data Analyses of Ongentys (opicapone) for Parkinson

Shots: In a post-hoc, sub-group analysis of the P-III BIPARK-1 study demonstrated greater reductions in overnight “off” time and time to morning “on” time compared to entacapone in patients with PD with motor fluctuations The new P-III post-hoc sub-group analysis demonstrated that long-term treatment with Ongentys when used as an add-on therapy reduced “On” time […]Read More

BMS Reports Results of Opdivo (nivolumab) in P-III CheckMate -274

Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery for up to 1yr. The study met its 1EPs of DFS in both all randomized patients and in patients whose tumor cells express […]Read More