SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling final overall survival data from its phase III INAVO120 study, showing that the Itovebi™ (inavolisib)-based regimen reduces the risk of death by more than 30% in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The findings were presented at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.

First PI3K Inhibitor to Prolong Survival in This Breast Cancer Subtype

The INAVO120 trial demonstrated that Itovebi, when combined with palbociclib and fulvestrant, achieved a median overall survival (OS) of 34.0 months compared to 27.0 months for the control group receiving palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement (HR=0.67; p=0.0190).

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.

The 96-week results presented at the CMSC Annual Meeting in Phoenix highlight fenebrutinib’s potential as a first-in-class reversible Bruton’s tyrosine kinase (BTK) inhibitor in the multiple sclerosis space. This development is poised to influence treatment paradigms, particularly as Phase III results approach later this year.

Sustained Disease Control With No Observed Disability Progression

SHERIDAN, WYOMING – May 27, 2025 – Heidelberger Druckmaschinen AG (HEIDELBERG) has launched its 2025/26 financial year with exceptional results, driven by its standout performance at China Print 2025 in Beijing. The company’s strategic emphasis on packaging and digital printing proved highly effective, resulting in the sale of nearly 350 printing units—well above expectations—and setting a solid course for continued growth in the Asian market.

Strong Demand Underscores HEIDELBERG’s Market Leadership

Attracting around 120,000 attendees and over 1.3 million online viewers, China Print reaffirmed its status as the region’s premier print industry event. HEIDELBERG recorded the highest visitor numbers at the show, where customers from across Asia expressed robust interest in the company’s end-to-end printing solutions.

SHERIDAN, WYOMING – May 27, 2025 – In a pivotal move to diversify its production capabilities, Plural Industria Grafica LTDA, one of South America's leading offset printing firms, has integrated sheetfed offset technology from Heidelberger Druckmaschinen AG (HEIDELBERG) into its operations for the first time. This landmark decision underscores Plural's commitment to capturing new market segments and enhancing cost-efficiency for shorter print runs.

Expanding Beyond Traditional Web Offset

Based in Santana de Parnaíba, São Paulo, Plural has long been a dominant force in web offset printing, serving sectors from publishing to commercial and security printing. With its newly installed Speedmaster XL 106-8-P+L and the 100th unit of the fourth-generation CutStar reel sheeter, the company is now targeting previously inaccessible market segments that demand shorter run lengths.

SHERIDAN, WYOMING – May 27, 2025 – Heidelberger Druckmaschinen AG (HEIDELBERG) has successfully navigated a challenging economic landscape, achieving its fiscal year 2024/25 targets while laying the groundwork for further growth in 2025/26. The company maintained a stable adjusted EBITDA margin of 7.1 percent and generated a clearly positive free cash flow of around €50 million, despite rising wage costs, a slightly lower sales volume, and expenses related to the drupa trade fair.

Sales reached approximately €2.28 billion, just under the previous year’s €2.395 billion. The fourth quarter was a standout, with sales accelerating and the adjusted EBITDA margin doubling to around 10 percent compared to the prior year.

Resilient Financial Management and Profitability Focus

SHERIDAN, WYOMING – May 27, 2025 – Seaway Printing has taken a bold step toward fully autonomous production, becoming the first U.S. customer to implement HEIDELBERG’s Plate to Unit system, and integrating the world’s first Inline Splicer with the CutStar generation 4 sheeter. The move is part of a sweeping automation strategy aimed at significantly improving productivity and operational efficiency across Seaway’s expanded Wisconsin facility.

Located in De Pere, Wisconsin, Seaway recently doubled its production capacity to meet surging demand for short-run book and magazine printing. With new HEIDELBERG technology embedded in prepress, press, and postpress operations, the company now operates with fewer manual interventions and has optimized labor usage by allowing each machine to be managed by just one operator.

Breakthrough in Prepress and Plate Logistics

SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.

This development is underpinned by data from the phase III INAVO120 study, which demonstrated that the Itovebi-based regimen more than doubled progression-free survival compared to the standard treatment alone. The recommendation marks a key milestone toward potential European Commission approval, with broader implications for treatment standards across the region.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced a new strategic collaboration with Broad Clinical Labs, aiming to accelerate the adoption of its next-generation Sequencing by Expansion (SBX) technology, with an initial focus on trio-based whole genome sequencing for critically ill newborns and their biological parents. The partnership signifies a pivotal move in expanding genomics-enabled healthcare and precision medicine at scale.

This joint initiative is poised to establish SBX as a clinical mainstay in neonatal intensive care units (NICUs), helping identify genetic disorders in newborns with unprecedented speed and precision. It also positions both organizations to lead in delivering fast, scalable, and cost-efficient genomic insights that could redefine diagnostic and therapeutic practices.

Targeting Transformational Impact in Clinical Genomics

SHERIDAN, WYOMING – May 27, 2025 – Roche has unveiled compelling two-year follow-up data from its pivotal phase III STARGLO trial, reinforcing the long-term clinical value of Columvi® (glofitamab) in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The results underscore the strategic impact of Roche’s bispecific antibody pipeline in addressing aggressive hematologic malignancies with limited treatment options.

Landmark Survival Benefit in R/R DLBCL

The updated STARGLO data show a 40% improvement in overall survival for patients treated with Columvi plus GemOx (gemcitabine and oxaliplatin), compared to the control arm receiving MabThera®/Rituxan® (rituximab) with GemOx. Notably, the median overall survival for the Columvi arm was not reached, versus 13.5 months in the comparator group.

Further findings demonstrated:

SHERIDAN, WYOMING – May 27, 2025 – Roche has received FDA approval for Susvimo® (ranibizumab injection) 100 mg/mL as a new treatment for diabetic retinopathy (DR), marking a pivotal advancement in the battle against this vision-threatening condition that affects nearly 10 million Americans.

The approval makes Susvimo the first and only FDA-approved continuous drug delivery system for DR, offering patients the potential to maintain vision with just one refill every nine months. This development adds a third approved indication for Susvimo, which is already cleared for neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema.