ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has launched a new HPV self-sampling solution in CE-mark-accepting countries, enabling women to privately collect samples for HPV screening at healthcare facilities. This initiative aims to improve access to cervical cancer screening, particularly in low- and middle-income countries where many cases are diagnosed at advanced stages. The solution aligns with Roche's commitment to the World Health Organization's strategy to eliminate cervical cancer. The cobas HPV test provides reliable results and can detect high-risk HPV types responsible for most cervical cancers.

Roche and Banner Alzheimer’s Institute reported that crenezumab failed to significantly slow cognitive decline in individuals with early-onset Alzheimer’s due to a specific genetic mutation. The study, part of a pioneering effort in Alzheimer’s prevention, involved 252 participants, 94% of whom completed the trial. Despite some numerical advantages for crenezumab across various measures, none were statistically significant. No new safety issues were found. Initial data will be presented at the Alzheimer's Association International Conference on August 2, 2022.

Roche has received Emergency Use Authorization (EUA) from the FDA for its cobas SARS-CoV-2 Duo test, a groundbreaking automated RT-PCR assay. This test provides both qualitative and quantitative results, enabling precise measurement of the viral load in COVID-19 patients. The test aims to enhance patient management by improving contact tracing and medical intervention strategies. By linking quantitative results to WHO standards, it facilitates consistent patient assessment across healthcare settings. The test will be available in the U.S. by Q2 2022.

Roche presented new long-term data at the EHA 2022 Congress, highlighting the effectiveness of its therapies for blood cancers. The phase III CLL14 study revealed that over 60% of previously untreated chronic lymphocytic leukaemia (CLL) patients remained in remission five years post-treatment with Venclexta plus Gazyva. Additionally, the final analysis of the phase III GALLIUM study demonstrated significant progression-free survival improvements with Gazyva plus chemotherapy for previously untreated follicular lymphoma patients.

Roche has announced FDA approval for FoundationOne CDx as a companion diagnostic for Rozlytrek, enhancing treatment for ROS1 fusion-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. FoundationOne CDx is the first FDA-approved test of its kind, leveraging comprehensive genomic profiling to personalize cancer therapy. The initiative represents a key milestone in developing tumor-agnostic cancer treatments, supported by Roche's leadership in diagnostic tools and drug development.

On June 9, 2022, Roche received approval from the European Commission for Tecentriq (atezolizumab) as an adjuvant treatment for adults with high-risk non-small cell lung cancer (NSCLC) following surgery and chemotherapy. This approval marks Tecentriq as the first cancer immunotherapy approved in Europe for early-stage NSCLC. In the Phase III IMpower010 trial, Tecentriq demonstrated a 57% reduction in the risk of disease recurrence or death, making it a significant advancement in lung cancer treatment. Roche plans further studies to analyze overall survival data.

The European Commission has granted conditional marketing authorization for Lunsumio® (mosunetuzumab), a bispecific antibody for treating adult patients with relapsed or refractory follicular lymphoma (FL). Based on the phase I/II GO29781 study, Lunsumio showed a 60% complete response rate and an 80% objective response rate, with the majority of responses lasting at least 18 months. This treatment is a chemotherapy-free, off-the-shelf option, potentially transforming FL management. Over 28,000 new FL cases are diagnosed annually in Europe.

Roche has received FDA approval for a label extension of Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in babies under two months. This decision is based on positive interim results from the RAINBOWFISH study, showing that most pre-symptomatic infants treated for a year achieved significant motor milestones, such as sitting, standing, and walking. Additionally, updated prescribing information reflects promising data from the FIREFISH study, indicating that symptomatic infants treated for two years can also meet key motor milestones.

Roche (OTCQX: RHHBY) announced pivotal data from the NP30179 expansion study of glofitamab at ASCO and EHA 2022, showing a 39.4% complete response rate in patients with heavily pre-treated diffuse large B-cell lymphoma (DLBCL) after a median follow-up of 12.6 months. Glofitamab offers a fixed-duration treatment approach, with 77.6% of responses being durable at 12 months. The drug is part of Roche's bispecific antibody development program, aimed at enhancing treatment for blood cancers. Submissions for regulatory approval to the EMA and FDA are planned this year.