ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that the European Medicines Agency's CHMP has recommended the approval of Columvi (glofitamab), the first CD20xCD3 T-cell-engaging bispecific antibody for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Europe. This decision is based on promising results from the phase I/II NP30179 study, where Columvi demonstrated early and sustained complete responses in heavily pre-treated patients. With an estimated 36,000 new DLBCL cases per year in Europe, Columvi's potential for fixed-duration treatment offers hope for patients, allowing predictable treatment timelines without the need for cell collection. A final decision by the European Commission is anticipated soon, while the U.S. FDA is also reviewing Columvi for similar indications.

On April 26, 2023, Roche reported a 3% decline in Group sales for Q1 2023 to CHF 15.3 billion, largely driven by a decrease in demand for COVID-19 tests. Excluding this factor, sales grew by 8%. The Pharmaceuticals Division showed a 9% increase, fueled by demand for newer drugs like Vabysmo, while the Diagnostics Division saw a 28% sales decrease due to lower COVID-19 test sales. Notable highlights include the US approval of Polivy for aggressive blood cancer and positive phase III data for Vabysmo, which is becoming a leading growth driver. Roche confirmed its outlook for 2023, anticipating low single-digit sales decline due to COVID-19 product sales drop but solid growth in its core businesses.

Roche announced promising results from post-hoc analyses of four phase III studies indicating that Vabysmo (faricimab) dries retinal fluid faster with fewer injections than aflibercept for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The phase III TENAYA and LUCERNE studies for nAMD showed 77% of Vabysmo patients had no retinal fluid at 12 weeks compared to 67% with aflibercept. In DME studies, patients receiving Vabysmo had over 50% less macular leakage at 16 weeks. The findings were presented at the ARVO Annual Meeting, and Vabysmo is approved in 60 countries, having distributed over 800,000 doses globally, which is significant given that nAMD and DME affect over 40 million people worldwide.