Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb has received a positive recommendation from the CHMP of the EMA for Onureg (azacitidine) as maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission. This therapy is targeted at those not eligible for stem cell transplantation. The recommendation follows promising results from the QUAZAR^® AML-001 Phase 3 study, showing a median overall survival of 24.7 months for Onureg users compared to 14.8 months for placebo. The European Commission will review this recommendation within 67 days.

Bristol Myers Squibb (NYSE: BMY) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment of unresectable malignant pleural mesothelioma (MPM). This marks a significant advancement, as it has been over 15 years since new treatments have been approved for MPM. The European Commission will now review this recommendation, which is based on the encouraging results of the CheckMate -743 trial, showcasing superior overall survival compared to chemotherapy.

Bristol Myers Squibb announced FDA approval for Opdivo (nivolumab) in combination with chemotherapy for treating patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression. This approval stems from the Phase 3 CheckMate -649 trial, where Opdivo plus chemotherapy improved overall survival (OS) and reduced the risk of disease progression. Notably, one-year survival rates reached 55% with Opdivo compared to 48% for chemotherapy alone. The approval was expedited through the FDA's Real-Time Oncology Review program.

Bristol Myers Squibb (NYSE: BMY) has received approval from the European Commission for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as a first-line treatment for adults with advanced renal cell carcinoma (RCC). This decision follows the successful Phase 3 CheckMate -9ER trial, highlighting superior efficacy in key endpoints such as progression-free survival and overall survival compared to sunitinib. The combination treatment demonstrated manageable safety with low treatment-related discontinuations, broadening options for RCC patients in Europe.

Bristol Myers Squibb (NYSE: BMY) reported significant results from the CheckMate -816 study, demonstrating that neoadjuvant treatment with Opdivo (nivolumab) plus chemotherapy resulted in a pathologic complete response (pCR) of 24% compared to 2.2% for chemotherapy alone (p<0.0001). This trial is the first Phase 3 study showing improved pCR in resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). Additionally, Opdivo plus chemotherapy was well tolerated, with no new safety signals detected. The findings suggest potential benefits for long-term survival in NSCLC patients.

Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the Phase 3 CheckMate -648 trial, which evaluated the combination of Opdivo (nivolumab) with chemotherapy or Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Results showed significant improvements in overall survival (OS) and progression-free survival (PFS) for both combinations in patients expressing PD-L1. The safety profiles were consistent with previous reports. Upcoming data will be shared at a medical conference and with health authorities.

HUYABIO International has announced a clinical collaboration with Bristol-Myers Squibb to conduct a Phase 3 trial evaluating the combination of HBI-8000 and Opdivo® (nivolumab) for treating unresectable or metastatic melanoma. Following a successful Phase 2 study that reported an overall response rate above 70%, this trial aims to further assess safety and efficacy. HBI-8000 is an epigenetic immunomodulator already approved for lymphoma and metastatic breast cancer in China.

Bristol Myers Squibb (NYSE:BMY) will host a virtual Investor Event on April 23, 2021, at 10:30 a.m. ET. The event will discuss data from the Phase 3 trials POETYK PSO-1 and PSO-2 of deucravacitinib, focused on treating moderate-to-severe psoriasis. The findings will be presented during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX). Investors and the public can access the live webcast and materials at investor.bms.com, with an archived version available later the same day.

Bristol Myers Squibb (BMY) announced the validation of its type II variation application by the European Medicines Agency for Opdivo (nivolumab) to treat high-risk muscle-invasive urothelial carcinoma post-surgery. This validation confirms a complete submission, initiating the EMA’s centralized review. Opdivo showed significant potential in reducing cancer recurrence risk in the CheckMate -274 trial, with a strong safety profile. The application marks a step towards providing a first adjuvant immunotherapy option for this patient demographic in the EU.