Roche's Ophthalmic Bispecific Antibody Gains Third EU Indication; J&J's Daratumumab Quadruplet Therapy Approved by FDA; BioNTech Reports Positive mRNA Vaccine Combination Trial Results

Aug 01, 2024 19:30 CST Updated 19:30

Johnson & Johnson

Medical Device R&D and Manufacturer

BioNTech

Developer of Novel Biologics

Roche's Ophthalmology Bispecific Antibody Receives EU Approval Again, Secures Third Indication

On July 31, Roche announced that the European Commission (EC) had approved the bispecific antibody Vabysmo (faricimab) for the treatment of vision impairment caused by macular edema due to retinal vein occlusion (RVO). This marks the third indication for Vabysmo in the EU, with previous approvals including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three retinal conditions collectively affect nearly 80 million people and are among the leading causes of vision loss worldwide.

Faricimab is a bispecific antibody that can simultaneously target and block two key pathogenic pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). The drug neutralizes Ang-2 and VEGF-A, targeting and inhibiting two signaling pathways associated with various vision-threatening retinal diseases. Ang-2 and VEGF-A destabilize blood vessels, leading to the formation of new leaky vessels and increased inflammation, which can result in vision loss.

This approval is based on the positive results of two global Phase III studies, BALATON and COMINO, which evaluated the efficacy of faricimab in more than 1,200 patients with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).

Johnson & Johnson's Daratumumab (Subcutaneous Injection) Quadruple Therapy Receives FDA Approval

On July 30, Johnson & Johnson announced that the FDA had approved the supplemental Biologics License Application (sBLA) for daratumumab subcutaneous injection formulation (brand name: Darzalex Faspro) for use in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) as induction and consolidation therapy for newly diagnosed multiple myeloma (NDMM) adult patients who are eligible for autologous stem cell transplantation (ASCT).

The approval of this new indication is mainly based on the positive results of the Phase III PERSEUS study. This study is a randomized, open-label clinical trial (709) that evaluated the efficacy and safety of subcutaneous daratumumab in combination with the VRd regimen (bortezomib + lenalidomide + dexamethasone) versus the VRd regimen as first-line treatment for newly diagnosed multiple myeloma. The primary endpoint of the study was progression-free survival (PFS).

Preliminary analysis results showed that, after patients received D-VRd as induction and consolidation therapy followed by D-R as maintenance therapy, the risk of disease progression or death was reduced by 60% (HR=0.40; 95% CI: 0.29–0.57; P<0.0001). Compared with patients who received VRd as induction and consolidation therapy followed by R as maintenance therapy, the D-VRd + D-R group had a higher rate of minimal residual disease (MRD) negativity (57.5% vs. 32.5%) and a higher proportion of MRD-negative patients achieving complete response (CR) or better (76.6% vs. 58.5%).

Clinical Results of BioNTech mRNA Vaccine Combination Therapy Announced

BioNTech Announces Positive Topline Data from Ongoing Phase 2 Trial of mRNA Cancer Vaccine BNT111

The BNT111-01 trial, which has been announced this time, is an open-label, randomized trial designed to evaluate the efficacy and safety of BNT111 and cemiplimab as monotherapies or in combination for the treatment of patients with recurrent, unresectable stage III and IV melanoma who are resistant to PD-1 or PD-L1 therapies. A total of 184 patients were enrolled and received treatment for up to 24 months.

The analysis showed that the trial met the primary efficacy endpoint, with a statistically significant improvement in ORR among patients receiving BNT111 in combination with cemiplimab compared to a historical control group of a similar patient population. Both randomized monotherapy groups demonstrated clinical activity, and the ORR in the cemiplimab monotherapy group was consistent with historical outcomes from prior treatments targeting PD-1, PD-L1, or CTLA-4.

Editor: Allen