Roche Hldg Stock Price, News & Analysis

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.

Genentech, part of Roche Group (OTCQX: RHHBY), announced promising post-hoc data from Phase III studies concerning Vabysmo for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The data demonstrate that Vabysmo led to a faster reduction in retinal fluid and required fewer injections compared to aflibercept. In wet AMD patients, 77% achieved absence of retinal fluid at 12 weeks versus 67% with aflibercept. In DME, Vabysmo patients experienced nearly four months earlier absence of DME compared to aflibercept. The studies were highlighted at the 2023 ARVO Annual Meeting, confirming Vabysmo's potential in managing significant vision-threatening conditions affecting millions globally.

Genentech, a member of Roche, announces new partnerships to enhance brain health outcomes. These initiatives aim to assess the complexities and economic impacts of neurological diseases. Key data presented include results showing delayed disability in multiple sclerosis (MS) patients treated with Ocrevus and reduced disease activity with Enspryng in neuromyelitis optica spectrum disorder (NMOSD). Evrysdi also shows significant benefits for spinal muscular atrophy (SMA). Genentech invests over $14.7 billion in R&D, with 20% dedicated to addressing brain health disorders. They will present 33 abstracts at the upcoming American Academy of Neurology meeting, highlighting long-term treatment data and ongoing research initiatives. Genentech aims to build resilient health systems and improve patient outcomes.

Genentech, a part of Roche Group (OTCQX: RHHBY), announced FDA approval for Polivy® (polatuzumab vedotin-piiq) in combination with R-CHP, marking the first new first-line treatment for diffuse large B-cell lymphoma (DLBCL) in nearly 20 years. The pivotal POLARIX trial demonstrated a 27% reduction in the risk of disease progression compared to the standard R-CHOP treatment. Approximately 31,000 DLBCL diagnoses are projected in the U.S. in 2023, with a significant number of patients experiencing relapse. This approval shifts Polivy’s status from accelerated to regular approval, enhancing access to a therapy that may improve patient outcomes significantly.

Roche has received FDA approval for Polivy in combination with Rituxan and other agents for treating diffuse large B-cell lymphoma (DLBCL), marking the first new therapy for this aggressive cancer in nearly 20 years. The combination showed a 27% reduction in disease progression risk in the POLARIX trial compared to the standard R-CHOP regimen, with a similar safety profile.

This approval transitions Polivy from accelerated to regular approval, expanding treatment options for the estimated 31,000 new DLBCL cases expected in the U.S. in 2023. Roche is exploring further studies to enhance Polivy's effectiveness, indicating a strong potential for market growth and improved patient outcomes.

Roche has announced groundbreaking results from the Phase III IMbrave050 study, showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) significantly reduced the risk of disease recurrence in patients with hepatocellular carcinoma (HCC) following surgery. Specifically, the combination therapy resulted in a 28% reduction in recurrence risk compared to active surveillance, demonstrating its efficacy in high-risk patients. With up to 80% of HCC patients experiencing recurrence post-surgery, these results herald a potential shift in treatment standards. The findings will be presented at the AACR Annual Meeting 2023, with ongoing discussions with health authorities about future steps.