Healthcare & Biotech

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 – 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.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced an encouraging update on its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx), following discussion by the FDA’s Oncologic Drugs Advisory Committee (ODAC). The combination therapy demonstrated a significant 41% reduction in the risk of death in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for autologous stem cell transplant.

Landmark survival data in STARGLO trial supports regulatory momentum

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care

The VENTANA MET (SP44) RxDx Assay is the first FDA-approved companion diagnostic for detecting MET protein expression in NSQ-NSCLC patients. By identifying those with elevated levels of MET—a key predictive biomarker—the assay supports clinicians in selecting patients who are most likely to benefit from c-Met-targeted therapy.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced compelling final results from the decade-long APHINITY Phase III clinical trial, demonstrating a significant 17% reduction in the risk of death for patients with HER2-positive early-stage breast cancer who received a Perjeta® (pertuzumab)-based adjuvant therapy. These findings reinforce the strategic role of the Perjeta-based regimen in long-term disease management and will be presented as a late-breaking abstract at the 2025 ESMO Breast Cancer Congress.

Strategic Impact for High-Risk Patient Groups

The APHINITY study highlights even stronger benefits in a key subgroup: patients with lymph node-positive disease experienced a 21% reduction in mortality risk. This outcome strengthens the treatment’s position in clinical practice, especially for those at heightened risk of recurrence.

SHERIDAN, WYOMING – May 27, 2025 – Roche has introduced its Elecsys® PRO-C3 diagnostic test, marking a major step forward in the assessment of liver fibrosis severity, particularly in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). With the ability to deliver results in just 18 minutes, the new test is poised to streamline diagnostics and enable earlier, more accurate clinical decision-making.

Strategic Response to a Global Health Burden

MASLD, affecting approximately 30% of the global population, is increasingly prevalent due to rising rates of diabetes, obesity, and other cardiometabolic risk factors. While it contributes to around one in every 25 deaths globally, liver fibrosis associated with MASLD often progresses unnoticed until late stages, escalating risks of cirrhosis, liver failure, and cancer.