Workflow
dexamethasone
icon
Search documents
Bristol-Myers Squibb (BMY) Reports Strong Multiple Myeloma Data
Yahoo Finance· 2025-10-02 06:33
Core Insights - Bristol-Myers Squibb Company (NYSE:BMY) is highlighted as a top choice for retirement portfolios due to its promising clinical trial results [1] - The Phase 3 EXCALIBER-RRMM trial demonstrated significant improvements in minimal residual disease negativity rates for patients with relapsed or refractory multiple myeloma when treated with iberdomide, daratumumab, and dexamethasone [1][2] Company Overview - Bristol-Myers Squibb is a multinational biopharmaceutical corporation involved in product discovery, research, licensing, manufacturing, marketing, and distribution [3] Drug Development - Iberdomide is classified as a cereblon E3 ligase modulator (CELMoD), leveraging the company's expertise in protein degradation [2] - The ongoing trial will also evaluate progression-free survival and key secondary endpoints such as survival rate and safety [2]
C4 Therapeutics Presents Cemsidomide Phase 1 Multiple Myeloma Data Supporting Potential Best-in-Class Profile at the International Myeloma Society Annual Meeting
Globenewswire· 2025-09-20 15:00
Core Insights - C4 Therapeutics, Inc. presented promising Phase 1 clinical trial data for cemsidomide, an IKZF1/3 degrader, in combination with dexamethasone for treating relapsed/refractory multiple myeloma, showing a 50% overall response rate (ORR) at the highest dose level of 100 µg and a 40% ORR at the 75 µg dose level [1][2][10] Phase 1 Trial Results - The trial included 72 heavily pretreated patients, with a median of seven prior therapies, and demonstrated a median duration of response of 9.3 months [6][11] - Cemsidomide achieved over 50% degradation of IKZF1 and over 80% degradation of IKZF3, indicating strong pharmacodynamic effects [11][8] - Safety profile was favorable, with low rates of treatment-related adverse events and no discontinuations related to cemsidomide [7][11] Development Strategy - C4T plans to initiate a Phase 2 single-arm registrational trial in Q1 2026 and a Phase 1b trial in Q2 2026, both aimed at evaluating cemsidomide in combination with dexamethasone and a BCMA BiTE, respectively [12][13][16] - The company aims for accelerated approval pathways based on the promising safety and efficacy data [10][12] Market Context - Multiple myeloma remains an incurable disease, with a significant need for new therapeutic options, especially for patients who have progressed on existing treatments [17][4] - Cemsidomide is positioned as a potential class-leading treatment option due to its differentiated safety and efficacy profile, particularly in heavily pretreated patient populations [3][4][5]
GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma
ZACKS· 2025-05-26 16:46
Core Viewpoint - GSK's Blenrep combination therapy has received a positive opinion from the EMA's CHMP for treating relapsed or refractory multiple myeloma, marking a significant step towards regulatory approval in Europe and the United States [1][2][3]. Group 1: Regulatory Developments - The CHMP recommended Blenrep in combination with J&J's Velcade and dexamethasone, as well as with Bristol Myers' Pomalyst and dexamethasone for adult patients who have undergone at least one prior therapy [2]. - The European Commission will review the CHMP's opinion, with a decision expected in Q3 2025 [3]. - Blenrep combinations have already been approved in the UK and Japan in April and May 2025, respectively, and are under review in China, Canada, and Switzerland [8]. Group 2: Clinical Data - Data from the III DREAMM-7 and DREAMM-8 studies indicated that Blenrep combinations resulted in statistically significant improvements in progression-free survival (PFS) and overall survival compared to standard treatments [4]. - The safety and tolerability profiles of Blenrep combinations were consistent with the known profiles of the individual agents used in the studies [4]. Group 3: Market Performance - GSK's shares have increased by 14.3% year-to-date, contrasting with a 5.5% decline in the industry [5]. - The company is also awaiting a decision from the FDA regarding the Blenrep combination therapy, expected on July 23, 2025 [7]. Group 4: Historical Context - Blenrep was previously withdrawn from the U.S. market in November 2022 after failing to meet the primary endpoint in the DREAMM-3 study, which evaluated its efficacy as a monotherapy [9]. - The company aims to reintroduce Blenrep to the market for patients with relapsed or refractory multiple myeloma following the recent positive developments [10].