Shots: GSK has stopped the enrollment in its P-II INDUCE-3 trial, including discontinuing treatment with feladilimab, following the recommendation by IDMC The P-II INDUCE-3 study involves assessing feladilimab + Merck’s pembrolizumab vs PBO+ pembrolizumab in patients with PD-L1+ recurrent LA/m-HNSCC. Additionally, GSK has also stopped the P-II INDUCE-4 study that evaluates feladilimab vs PBO in […]Read More
Shots: The interim analysis of open-label P- IIIb ENSEMBLE study of Ocrevus (ocrelizumab) showed 85% of patients achieved no evidence of disease activity in early-stage RRMS, low annualized relapse rate, improvement in EDSS score The post-hoc analysis of P-III ORATORIO study of Ocrevus vs PBO showed slow loss of brain tissue within T2 MRI lesions […]Read More
Shots: The 2-year data from Part 2 of P-II/III FIREFISH study involves assessing Evrysdi in 41 infants aged 1-7mos. with symptomatic Type 1 SMA Results: improvement in maintained motor function b/w 12-24mos., babies were able to sit without support for at least 5sec. after 24mos. vs 12mos. (61% vs 29%), 92% maintained the ability to […]Read More
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%), […]Read More
Shots: J&J temporarily pause the use of the COVID-19 vaccine in the US, following recommended of the CDC and FDA. The review data involves six reported cases of a rare and severe type of blood clot in the US after receiving the J&J vaccine The pause is due to the unusual clotting in 6 women […]Read More
Shots: The P-II KINETIC study involves assessing the efficacy, safety, and tolerability of SAGE-324 (60mg, qd) vs PBO in 69 patients in a ratio (1:1) aged 18-80yrs. with essential tremor for 29 days The study met its 1EPs i.e reduction from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score @29day (36% vs […]Read More
Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs 2.2%) and showed improvement in 2EPs i.e. MPR (36.9% vs […]Read More
Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs 13.8 mos.), ORR (80.8% vs 47.7%), CR (33.9% and 14.6%), […]Read More
Shots: The first patient has been dosed in a P-II two-part OLE study that assesses the safety, efficacy, and PK of Pexidartinib {800mg/day (400mg, bid on an empty stomach)} in ~18 patients with symptomatic TGCT associated with severe morbidity or functional limitation and not amenable to improvement with surgery The 1EP of the study is […]Read More
Shots: The P-III DARE-19 trial involves assessing the efficacy and safety of Farxiga vs PBO in addition to SoC therapy in 1,250 hospitalized patients with COVID-19 who are at high risk of developing serious complications The trial fails to meet its 1EP of prevention measures organ dysfunction, all-cause mortality, and recovery measuring a change in […]Read More
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