ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has launched new high-capacity analytical units, cobas c 703 and cobas ISE neo, for the cobas pro integrated solutions, targeting laboratories in CE mark regions.

The cobas c 703 analytical unit doubles the throughput to 2,000 tests per hour and offers 70 reagent positions, significantly boosting clinical chemistry testing efficiency. The cobas ISE neo unit enhances ion selective electrode testing with up to 1,800 tests per hour and features automated maintenance, reducing manual intervention.

These units are designed to address challenges like staff shortages and space limitations, offering increased automation and efficiency to improve lab workflows and patient care.

Roche has launched the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved highly-sensitive in-situ hybridisation (ISH) test to diagnose B-cell lymphoma. This test helps distinguish B-cell cancers from normal immune responses, providing diagnostic certainty for healthcare providers. B-cell lymphoma accounts for about 85% of non-Hodgkin lymphoma (NHL) cases, the tenth most common cancer globally. This CE Mark-approved test can identify over 60 B-cell lymphoma subtypes and plasma cell neoplasms using a single tissue slide, reducing the need for fresh tissue samples and additional biopsies. The assay is part of Roche’s extensive hematopathology portfolio.

Roche announced that its VENTANA DP 200 digital pathology solution has received FDA 510(k) clearance for diagnostic use. This clearance allows pathologists to use digital images for primary diagnosis, enhancing healthcare efficiency and patient care, especially in remote areas. The solution includes a slide scanner, workflow software, and a display, aiming to streamline digital pathology workflows. By enabling timely diagnoses from anywhere, this innovation supports greater pathologist collaboration and improved lab efficiency. Roche emphasizes its commitment to digital transformation and AI-based tools in pathology.

Roche's Phase III STARGLO study of Columvi (glofitamab) in combination with GemOx chemotherapy shows promising results for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint, with a 41% reduction in the risk of death compared to R-GemOx. Key secondary endpoints were also met, with a 63% reduction in the risk of disease progression. Median overall survival was 25.5 months for the Columvi combination, nearly double that of R-GemOx. Safety profiles were consistent with known data. Results will be submitted to global health authorities including the FDA and EMA.

Roche has received U.S. FDA Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This four-in-one molecular test utilizes PCR technology for rapid and accurate detection of these viruses within 20 minutes. It requires a single nasal-swab sample, making it suitable for various healthcare settings such as emergency departments and urgent care facilities. The test aims to facilitate swift clinical decision-making, reduce unnecessary antibiotic use, and enhance patient outcomes. Future plans include seeking FDA 510(k) clearance and a CLIA waiver in the U.S., as well as commercial launches in other markets post CE-IVDR approval.

The European Commission has approved Roche’s Alecensa (alectinib) as the first targeted adjuvant treatment for ALK-positive early-stage lung cancer. This approval, backed by Phase III ALINA study data, showed a 76% reduction in the risk of disease recurrence or death compared to chemotherapy. Alecensa is now available for patients with resected stage IB to IIIA ALK-positive non-small cell lung cancer (NSCLC). The ALINA study also showed improved central nervous system disease-free survival. The safety profile of Alecensa remains consistent with prior studies. This approval follows the FDA's approval in April 2024, with global submissions ongoing.

Roche announced five-year data for Evrysdi (risdiplam) showing significant efficacy in treating children with Type 1 spinal muscular atrophy (SMA). The FIREFISH study revealed that 91% of children were alive, with 81% surviving without permanent ventilation. Motor skills improvements were noted, with 59% able to sit unaided for at least 30 seconds, and some able to stand or walk with or without support. The study also showed high rates of maintaining swallowing and feeding abilities. Evrysdi is now approved in over 100 countries, treating more than 15,000 patients globally. No treatment-related adverse events led to discontinuation, and adverse event rates decreased over the study period.

Roche announced that the FDA granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The decision is based on positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival (15.0 months vs. 7.3 months) and reduced the risk of disease worsening or death by 57%. The FDA's target decision date is 27 November 2024. Further analyses will be presented at the 2024 ASCO Annual Meeting. Roche is also filing submissions with other global health authorities.

Genentech, part of Roche Group (OTCQX: RHHBY), announced that the FDA has accepted its New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy. This therapy, combined with palbociclib and fulvestrant, targets advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The Priority Review is based on Phase III INAVO120 trial results, which showed that the inavolisib-based regimen more than doubled progression-free survival (15.0 months vs. 7.3 months) compared to palbociclib and fulvestrant alone. The FDA's target action date is November 27, 2024. Genentech is also planning submissions to other global health authorities and will present additional analyses at the 2024 American Society of Clinical Oncology Annual Meeting.