ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that the pivotal phase III POLARIX trial for Polivy in combination with chemotherapy regimen R-CHP has met its primary endpoint, showing significantly improved progression-free survival in previously untreated diffuse large B-cell lymphoma (DLBCL) patients compared to standard treatment R-CHOP. Given that 40% of DLBCL patients relapse, this outcome could transform first-line treatment. Roche plans to submit these results to health authorities globally and will present them at an upcoming medical meeting.

Roche has received FDA acceptance for its supplemental Biologics License Application for Tecentriq (atezolizumab) as an adjuvant treatment for non-small cell lung cancer (NSCLC). The application is based on Phase III IMpower010 study results, demonstrating a 34% reduction in disease recurrence or death in patients with PD-L1-positive NSCLC compared to best supportive care. The FDA's review falls under the Real-Time Oncology Review program, aiming for expedited availability of effective treatments. A decision is expected by December 1, 2021.

Roche announced that the FDA has accepted its Biologics License Application for faricimab, targeting neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) under Priority Review. Faricimab could be the first bispecific antibody for eye treatments, addressing two pathways implicated in retinal diseases. Phase III trials showed that nearly half of patients could extend treatment intervals to four months, maintaining vision gains comparable to the standard care, aflibercept. The European Medicines Agency has also validated the marketing application for faricimab.

Roche announced positive results from the FIREFISH Part 2 study, demonstrating that Evrysdi significantly benefits infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). By month 12, 29% of infants could sit unsupported, while 93% remained alive, and 85% were free from permanent ventilation. The study showed promising motor milestone improvements with Evrysdi, and safety was consistent with established profiles. RHHBY has treated over 4,000 patients globally, revealing Evrysdi’s potential in addressing SMA, a leading genetic cause of infant mortality.

Genentech announced the publication of pivotal study results for Evrysdi (risdiplam) in Type 1 spinal muscular atrophy (SMA) in the New England Journal of Medicine. In the FIREFISH Part 2 study, 29% of infants (12/41) achieved the significant motor milestone of sitting unsupported for at least 5 seconds by month 12. The treatment demonstrated consistent safety with 93% of infants alive and 85% free from permanent ventilation at the same time point. The drug is part of the collaboration with the SMA Foundation and is being evaluated in multiple trials worldwide.

Roche reported an 8% increase in Group sales at constant exchange rates for H1 2021, totaling CHF 30.7 billion. The Pharmaceuticals Division experienced a 3% sales decline, offset by a 51% surge in Diagnostics, driven by COVID-19 tests. Key highlights include positive study results for Tecentriq in lung cancer and new EU approvals for Venclyxto and Enspryng. Despite continued biosimilar challenges, new medicines recorded 30% growth. Roche maintains its 2021 outlook, expecting low to mid-single-digit sales growth. Core EPS rose by 6%, affirming the company's strong market position amid recovery signs in the Pharma Division.

Roche has received Breakthrough Therapy Designation (BTD) from the FDA for Venclexta® (venetoclax) in combination with azacitidine, targeting previously untreated higher-risk myelodysplastic syndromes (MDS). With approximately 10,000 annual diagnoses in the U.S., MDS presents significant treatment challenges. This designation, based on the phase Ib M15-531 study, marks the 11th BTD for Roche's haematology portfolio and reinforces Venclexta's potential in blood cancer therapy. The median survival for higher-risk MDS patients is roughly 18 months, highlighting the urgent need for effective treatments.

On July 20, 2021, Roche announced full approval from Japan's Ministry of Health for Ronapreve (casirivimab and imdevimab) to treat mild to moderate COVID-19 via intravenous infusion. This approval is based on a global Phase III trial demonstrating a 70% reduction in hospitalization or death for high-risk non-hospitalized patients. The treatment retains efficacy against emerging variants, including Delta. The drug has gained emergency use authorization in the EU and the US, with ongoing assessments for broader application. Roche aims to ensure timely availability in Japan through collaboration with Chugai.

The final analysis from the phase IIIb STASEY study has demonstrated the continued safety and efficacy of Hemlibra (emicizumab) for treating individuals with haemophilia A who have inhibitors to factor VIII. The study, which included data from 193 participants, reported a zero treated bleed rate in 82.6% of patients, with no new safety signals identified over longer-term treatment. Common side effects included joint pain and cold symptoms, while anti-drug antibody incidence remained low. Hemlibra is approved in over 100 countries worldwide.