BMS Receives FDA Approval for Opdivo in Untreated Advanced Urothelial Cancer; GSK Reports Positive Phase III Results for BCMA ADC Blenrep; Novo Nordisk Announces Promising Early Data for Oral Weight-Loss Therapy Amycretin

Mar 08, 2024 21:12 CST Updated 21:13

GSK

Pharmaceutical R&D Manufacturer

BMS Opdivo New Indication Approved, Combined with Chemotherapy for First-Line Treatment of Advanced Urothelial Carcinoma (UC)

On March 7, Bristol-Myers Squibb announced that the U.S. FDA approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

This approval is based on the results of the Phase III CheckMate -901 clinical trial. In the trial, with a median follow-up of approximately 33 months, the Opdivo combination therapy group reduced the risk of death by 22%, with a median OS of 21.7 months compared to 18.9 months in the chemotherapy group (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171). Patients in the Opdivo combination therapy group had a 28% reduction in the risk of disease progression or death, with a median PFS of 7.9 months compared to 7.6 months in the chemotherapy group (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).

For the UC indication, the FDA previously approved Opdivo as an adjuvant treatment for adult UC patients at high risk of recurrence after radical surgery for UC; Opdivo was also previously approved for the treatment of adult patients with locally advanced or metastatic UC who experienced disease progression during or after platinum-containing chemotherapy, or who experienced disease progression within 12 months after neoadjuvant or adjuvant platinum-containing chemotherapy.

GSK BCMA ADC Second Head-to-Head Phase III Study Yields Positive Results

On March 7, GSK announced positive interim analysis results from the Phase III head-to-head trial (DREAMM-7), which evaluated Blenrep (belantamab mafodotin) in combination with pomalidomide and dexamethasone (PomDex) versus standard treatment with bortezomib plus PomDex as second-line and later therapy for relapsed or refractory multiple myeloma (R/R MM). In a pre-specified interim analysis, the trial met its primary endpoint of progression-free survival (PFS).

Compared with the standard treatment combination, the Blenrep combination therapy significantly prolonged the time to disease progression or death. A positive trend in overall survival (OS) favoring Blenrep combination therapy was also observed at the time of this analysis. The trial will continue follow-up. The safety and tolerability of the Blenrep regimen are generally consistent with the known safety profiles of the individual drugs.

This study is the second head-to-head combination Phase III trial of Blenrep for second-line and later treatment of MM. The Phase III DREAMM-7 study of Blenrep for second-line treatment of R/R MM also achieved positive interim results. Compared with daratumumab (Darzalex) combined with BorDex (bortezomib + dexamethasone), the combination of Blenrep and BorDex significantly extended the time to disease progression or death for patients.

Novo Nordisk's New Oral Weight-Loss Therapy Shows Positive Early Data, 13.1% Weight Loss in 12 Weeks

On March 7, Novo Nordisk held its Capital Markets Day (CMD) event. During the event, presentations by senior management of Novo Nordisk covered corporate strategy and goals with sustainability (ESG), research and early development, product offerings in the diabetes, obesity, and rare disease areas, as well as the R&D pipeline and performance. Additionally, Novo Nordisk's approaches and financial status in the cardiovascular and emerging therapeutic fields were introduced.

At the same time, Novo Nordisk also announced the positive Phase I data of its new weight-loss candidate drugs, Amycretin (a novel long-acting co-agonist of GLP-1 and amylin) and Monlunabant (an oral small-molecule CB1R inverse agonist).

Novo Nordisk has developed two formulations for Amycretin: oral and subcutaneous injection. The data disclosed this time is for the oral formulation, and Phase I data for the subcutaneous formulation is expected to be obtained in 2025.

The study results showed that taking Amycretin orally once daily led to a 13.1% weight loss after 12 weeks. Amycretin demonstrated good safety and tolerability.

The results of the Phase I study of Monlunabant showed that by Day 28, the average weight loss in the Monlunabant group was 3.5kg (3.3%), while the placebo group gained 0.6kg (0.5%). Monlunabant demonstrated good safety and tolerability, with the most common side effects being gastrointestinal reactions.

Editor: Cheng Lin