Roche Holding AG - RHHBY STOCK NEWS

Roche announced that the FDA granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. This designation follows positive Phase III INAVO120 results showing the inavolisib-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; HR=0.43, 95% CI: 0.32-0.59, p<0.0001).

Approximately 40% of patients with HR-positive breast cancer have a PIK3CA mutation, often leading to poorer prognosis and resistance to endocrine treatment. Data from INAVO120 are being submitted to other health authorities. Inavolisib is under investigation in additional Phase III studies for advanced breast cancer.

Genentech, part of the Roche Group, reported positive Phase Ib results for its dual GLP-1/GIP receptor agonist, CT-388, in treating obesity.

Over 24 weeks, a weekly subcutaneous injection of CT-388 led to a significant placebo-adjusted weight loss of 18.8% (p < 0.001). Important results included 100% of treated participants achieving over 5% weight loss, 70% over 15%, and 45% over 20%. Additionally, pre-diabetic participants normalized their glycemia levels.

No new safety signals were detected. Adverse events were consistent with the incretin drug class. Further trials involving obese patients with type 2 diabetes are expected to report results in the second half of 2024.

Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in treating obesity and type 2 diabetes. Over 24 weeks, CT-388 achieved a significant placebo-adjusted weight loss of 18.8% (p < 0.001). At week 24, 100% of participants treated with CT-388 achieved >5% weight loss, 70% achieved >15%, and 45% achieved >20%. The treatment normalized glycemia in all pre-diabetic patients, showing strong glucose homeostasis impact. No new safety signals were detected, and the treatment was well-tolerated.

Looking forward, Roche plans to evaluate CT-388 in obese patients with type 2 diabetes over a 12-week treatment duration, with data expected in the second half of 2024.

Roche announced the FDA approval of its HPV self-collection solution, one of the first such options in the U.S. This tool improves access to HPV testing by allowing women to privately collect their own samples, which are then analyzed in a lab. The solution addresses a significant gap, as over half of U.S. cervical cancer patients are underscreened. Over 13,000 U.S. women are diagnosed with cervical cancer annually, and approximately 4,000 die from it. HPV self-collection could enable early detection and treatment, supporting the WHO's goal to eliminate cervical cancer by 2030. Roche collaborated with the National Cancer Institute for this initiative.

Roche reports a 2% increase in sales in the first quarter, with both pharmaceuticals and diagnostics divisions experiencing high single-digit growth excluding COVID-19 products. The company saw a 7% growth in pharmaceuticals driven by sales of medicines for severe diseases, while the diagnostics division grew by 8% due to demand for immunodiagnostic products.

Roche's Alecensa receives FDA approval as the first adjuvant treatment for ALK-positive early-stage lung cancer, demonstrating a 76% risk reduction in disease recurrence or death based on Phase III ALINA study.

The FDA has approved Genentech's Alecensa as the first adjuvant treatment for ALK-positive early-stage lung cancer. The approval is based on the Phase III ALINA study, demonstrating a 76% reduction in the risk of disease recurrence or death. This addresses a critical unmet need in this patient population.

Roche's subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS. The Phase III study results show that the subcutaneous injection is consistent with IV infusion and achieves near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks. The twice-yearly, 10-minute SC injection could expand OCREVUS usage to centers without IV infrastructure. Regulatory filings have been accepted by the FDA and EMA, with EU approval expected in mid-2024 and U.S. approval in September 2024.

Genentech's Columvi meets primary endpoint of overall survival in people with relapsed or refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO study, showing significant improvement in survival rates.