Roche Hldg Stock Price, News & Analysis

Roche (RHHBY) announced promising two-year follow-up data from the phase III STARGLO study for Columvi® in combination with chemotherapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a 40% improvement in overall survival compared to standard treatment. Key findings include:

- 89% of complete responders were alive one year post-treatment - 82% maintained remission after one year - 58.5% complete remission rate (vs 25.3% in control group) - 59% reduction in disease progression/death risk

The Columvi combination is now approved in over 30 countries for R/R DLBCL patients who aren't candidates for autologous stem cell transplant. The treatment's safety profile remained consistent with previous analyses, with cytokine release syndrome being a common but generally low-grade adverse event.

Genentech announced promising two-year follow-up data from the Phase III STARGLO study for Columvi in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a 40% improvement in overall survival for patients treated with Columvi combination therapy compared to standard treatment. After median follow-up of 24.7 months, patients receiving Columvi plus GemOx showed significant benefits: 89% of complete responders were alive and 82% maintained remission one year post-treatment. The study demonstrated a 59% reduction in disease progression/death risk and more than double the complete remission rate (58.5% vs 25.3%). Columvi combination is now approved in over 30 countries and included in NCCN Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment.

Roche (RHHBY) has received FDA approval for Susvimo to treat diabetic retinopathy (DR), marking its third approved indication. Susvimo, utilizing the Port Delivery Platform, is the first continuous delivery treatment requiring only one refill every nine months for DR patients who previously responded to anti-VEGF injections. The approval is based on the phase III Pavilion study, where patients showed superior improvements on the Diabetic Retinopathy Severity Scale compared to monthly observation with as-needed anti-VEGF injections. The treatment involves a refillable eye implant surgically inserted during an outpatient procedure. DR affects nearly 10 million people in the US and over 100 million globally. Notably, no participants required supplemental treatment at one year, and the safety profile remained consistent with previous findings.

The FDA has approved Genentech's Susvimo (ranibizumab injection) for treating diabetic retinopathy (DR), marking its third FDA-approved indication. This innovative treatment, utilizing the Port Delivery Platform, requires only one refill every nine months, offering an alternative to frequent eye injections. The approval follows successful Phase III Pavilion study results, where patients showed superior improvements on the Diabetic Retinopathy Severity Scale compared to monthly observation with as-needed anti-VEGF injections. Susvimo is administered through a refillable eye implant surgically inserted during an outpatient procedure. The treatment is specifically approved for DR patients who have previously responded to at least two anti-VEGF injections. DR affects nearly 10 million people in the US and over 100 million globally.

A FDA Advisory Committee discussed Roche's (RHHBY) supplemental Biologics License Application for Columvi in combination with GemOx for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The phase III STARGLO study demonstrated that the Columvi combination reduced death risk by 41% compared to standard treatment, with median overall survival of 25.5 months vs 12.9 months. The treatment also showed a 63% reduction in disease progression risk. While Committee members requested additional data regarding US patient applicability, the treatment is already approved in 30+ countries and included in NCCN guidelines as a category 1 preferred regimen. The FDA's final decision is expected by July 20, 2025.

Roche (RHHBY) has received FDA approval for its VENTANA MET (SP44) RxDx Assay, marking it as the first companion diagnostic test to identify non-squamous non-small cell lung cancer (NSQ-NSCLC) patients eligible for AbbVie's Emrelis treatment. The assay detects MET protein expression, a crucial biomarker for determining patient response to c-Met-targeted therapy.

The approval is backed by the Phase 2 LUMINOSITY study, which demonstrated a 35% overall response rate and 7.2 months median duration of response in patients with high c-Met protein expression treated with Emrelis. This development is particularly significant as approximately 25% of advanced NSCLC patients with normal EGFR genes show high MET protein levels.

Roche announced significant 10-year final overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer treatment. The study showed that combining Perjeta (pertuzumab) with Herceptin (trastuzumab) and chemotherapy reduced death risk by 17% compared to Herceptin, chemotherapy, and placebo. Key findings include:

- 91.6% survival rate at 10 years with Perjeta-based regimen vs 89.8% with standard treatment - 21% reduction in death risk for patients with lymph node-positive disease - Maintained invasive disease-free survival benefit - No benefit observed in node-negative subgroup - Consistent safety profile with no new concerns

The results validate the Perjeta-based regimen as a standard-of-care treatment in the curative setting, particularly beneficial for high-risk patients with lymph-node positive disease.

Genentech announced significant 10-year final overall survival results from the Phase III APHINITY study for HER2-positive early-stage breast cancer. The study showed that adding Perjeta (pertuzumab) to Herceptin and chemotherapy as post-surgery treatment reduced death risk by 17% compared to Herceptin, chemotherapy, and placebo. After 10 years, 91.6% of patients on the Perjeta-based regimen survived versus 89.8% in the control group. Notably, patients with lymph node-positive disease showed a 21% reduction in death risk. The safety profile remained consistent with previous studies, with no new safety concerns identified. The previously reported invasive disease-free survival benefit was maintained, though no benefit was observed in the node-negative subgroup.

Roche (RHHBY) has announced a significant $550 million investment to expand its Indianapolis diagnostics manufacturing facility by 2030. The expansion will transform the site into a major hub for manufacturing continuous glucose monitoring (CGM) systems. The Indianapolis campus, which currently produces 5.2 billion Accu-Chek® diabetes test strips annually, will see enhanced capabilities to serve both U.S. and global markets across 53 countries.

The investment aims to address the needs of over 38 million Americans living with diabetes by improving access to diabetes management solutions. The expansion will create hundreds of manufacturing jobs and thousands of construction positions, boosting Indiana's economy while strengthening domestic production capabilities. This investment builds upon Roche's previous $800 million investment in U.S. operations since 2015.