1. BRAFTOVI® combination therapy showed positive PFS in patients with BRAFV600E-mutant mCRC:
On February 3, 2025, Pfizer announced positive results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with BRAF V600E mutated metastatic colorectal cancer (mCRC). BRAFTOVI is an oral small molecule kinase inhibitor targeting BRAF V600E to prevent inappropriate activation of the MAPK signalling pathway. The trial significantly improved PFS (primary endpoint) and overall survival (secondary endpoint) results. Previously, the combination regimen received accelerated approval by the U.S. FDA in December 2024 for treatment-naïve patients with BRAFV600E-mutant mCRC based on the improvement in confirmed objective response rate (co-primary endpoint).
2. Gazyva®/Gazyvaro® significantly improved lupus nephritis outcomes:
On February 7, 2025, Roche announced detailed analysis from a phase III REGENCY trial evaluating Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN). The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR). Obinutuzumab is an anti-CD20 antibody and aims to deplete B cells, which generate antibodies targeting host proteins. In the study, 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy achieved CRR at 76 weeks compared to 33.1% of people treated with standard therapy alone. Other markers such as complement levels and anti-dsDNA were also reduced. In addition, more patients showed improvement in proteinuric response with fewer kidney damage in Gazyva/Gazyvaro plus standard therapy group versus standard therapy alone.
https://www.roche.com/media/releases/med-cor-2025-02-07
3. Approval of EMBLAVEO™ in the U.S. for intra-abdominal infections caused by certain bacteria:
On February 7, 2025, AbbVie announced that the U.S. FDA has approved EMBLAVEO™ (aztreonam and avibactam) consisting of aztreonam, a monobactam antibiotic, with avibactam, a broad-spectrum β-lactamase inhibitor. It is approved in combination with metronidazole, to treat adult patients complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. The evolution of antimicrobial resistance has limited the treatment options for patients, and this new approval provides new solutions to those difficult antimicrobial-resistant pathogens.
4. Omvoh® maintained long-term clinical remission and endoscopic response in Crohn’s disease:
On February 7, 2025, Eli Lilly and Company announced results from the VIVID-2 open-label extension study investigating the effects of Omvoh® (mirikizumab-mrkz) for Crohn's disease in the long term. Patients receiving two years of continuous treatment with Omvoh achieved long-term clinical and endoscopic outcomes. Omvoh reduces intestinal inflammation by inhibiting interleukin-23p19. Among patients who achieved clinical remission at one year, 92.9% maintained clinical remission at two years as measured by the Crohn's Disease Activity Index. Among patients treated in VIVID-2, 87.6% maintained endoscopic response, and among those who achieved endoscopic remission at one year, 78.6% of them maintained endoscopic remission at two years.
5. Mim8 mimicked the cofactor function and effectively reduced bleeding in haemophilia A:
On February 7, 2025, Novo Nordisk announced results from the phase 3 FRONTIER3 trial on haemophilia A with and without inhibitors. In part one of the study, participants were receiving once-weekly prophylaxis treatment (regular treatment to prevent prolonged and spontaneous bleeding) with investigational Mim8 and after 26 weeks, participants had the option to change to once-monthly dosing or continue the weekly dosing. In the first part of the study, the estimated average annualised bleeding rate (ABR) was 0.53, and 74.3% of participants had zero treated bleeds. Mim8 is a bispecific antibody mimicking the function of Factor VIII by crosslinking Factor IXa and Factor X, which allows normal blood clotting.
6. EYLEA HD® (aflibercept) 8 mg maintained the vision improvement while extended the dosing intervals in different eye conditions:
On February 8, 2025, Regeneron Pharmaceuticals and Bayer announced two new regarding EYLEA HD® (aflibercept) Injection 8 mg, which is a fusion protein targeting VEGFs. Firstly, the three-year extension study of it on wet age-related macular degeneration (wAMD) showed that the treatment sustained the visual gains and anatomic improvements. Meanwhile, patients who switched from 2 mg dosing to 8 mg dosing maintained the improvement throughout the year. Secondly, EYLEA HD® received positive results in treating macular edema following retinal vein occlusion (RVO). The trial showed that over 36 weeks, the 8 mg dosing group showed non-inferior effects compared to the 2 mg dosing group. Researchers said that EYLEA HD can improve vision with extended dosing intervals compared to the original dosage form.
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