Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb's Breyanzi has shown significant clinical benefits for patients with various B-cell malignancies, according to new data presented at the 2024 ASCO Annual Meeting. The three-year follow-up from the Phase 3 TRANSFORM trial demonstrates sustained event-free survival and durable responses in patients with large B-cell lymphoma (LBCL), outperforming standard care.

The study also highlights Breyanzi's consistent efficacy and safety in mantle cell lymphoma (MCL) and follicular lymphoma (FL) across different subgroups, regardless of the number of prior treatments or use of bridging therapy. This underscores Breyanzi's potential for earlier lines of treatment and relapsed or refractory cases. Recently, the FDA granted accelerated approval for Breyanzi in relapsed or refractory FL and MCL, expanding its use across four types of B-cell lymphomas.

These findings emphasize Breyanzi's role as a transformative CAR T cell therapy with a robust clinical profile, offering hope for improved patient outcomes.

Bristol Myers Squibb presented multiple analyses at the 2024 ASCO Annual Meeting showcasing Opdivo and Opdivo-based combinations for non-small cell lung cancer (NSCLC).

Key findings include: improved event-free survival and pathologic complete response in stage III resectable NSCLC patients from the CheckMate -77T study; four-year survival data from CheckMate -816 showing enhanced event-free survival with neoadjuvant Opdivo plus chemotherapy; and five-year data from CheckMate -9LA indicating survival benefits with Opdivo plus Yervoy and chemotherapy in metastatic NSCLC patients.

Additional studies showed promising results for Augtyro and KRAZATI in specific NSCLC patient subsets. No new safety concerns were noted across these studies.

Bristol Myers Squibb announced that KRAZATI (adagrasib) showed a statistically significant improvement in progression-free survival (PFS) for patients with pretreated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) compared to standard chemotherapy in the Phase 3 KRYSTAL-12 study. Median PFS was 5.5 months for KRAZATI versus 3.8 months for chemotherapy. The overall response rate (ORR) was 32% with KRAZATI compared to 9% for chemotherapy. KRAZATI also demonstrated a higher intracranial response rate in patients with CNS metastases. The safety profile of KRAZATI was consistent with known data, with treatment-related adverse events reported in a high percentage of patients. These results will be presented at the 2024 ASCO Annual Meeting.

Bristol Myers Squibb (NYSE: BMY) has received FDA approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CAR T cell therapy targeting relapsed or refractory mantle cell lymphoma (MCL). This marks the fourth subtype of non-Hodgkin lymphoma for which Breyanzi is approved. In the TRANSCEND NHL 001 trial, Breyanzi demonstrated an 85.3% response rate, with a 67.6% complete response rate in patients who had at least two prior lines of systemic therapy, including a BTK inhibitor. The treatment involves a one-time infusion and has shown a consistent safety profile, making it an option for outpatient management. Despite high rates of response, significant risks such as Cytokine Release Syndrome (CRS) and neurologic toxicities persist. The approval extends Breyanzi's reach in treating B-cell malignancies, offering new hope for patients with options.

Bristol Myers Squibb announced European Commission approval for Opdivo® (nivolumab) combined with cisplatin and gemcitabine for first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The approval was based on the CheckMate -901 Phase 3 trial, which demonstrated that the combination improved overall survival and progression-free survival compared to chemotherapy alone.

Results from the trial showed a 22% reduction in the risk of death and a 28% reduction in the risk of disease progression or death. The combination also resulted in a higher overall response rate of 57.6% versus 43.1% with chemotherapy alone. These findings position Opdivo with chemotherapy as a new standard of care for this patient population in the EU.

Serious adverse reactions affected 48% of patients, with common side effects including nausea, fatigue, and musculoskeletal pain. The combination treatment has been approved for use in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Bristol Myers Squibb (BMS) has announced a 10-year initiative called ASPIRE to address health inequities in low- and middle-income countries (LMICs). The ASPIRE strategy, which stands for Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity, aims to reach over 208,000 patients in LMICs by 2033. BMS is collaborating with the Access to Oncology Medicines (ATOM) Coalition to make Opdivo™ (nivolumab) available in select LMICs, including Pakistan, Rwanda, and Zambia, by 2026. This initiative focuses on improving access to immuno-oncology therapies and strengthening health systems, aligning with BMS's commitment to global health equity and their Environmental, Social, and Governance (ESG) strategy.

Bristol Myers Squibb (NYSE: BMY) will present data from over 130 studies on approximately 25 cancer types and blood disorders at the 2024 ASCO and EHA meetings. Highlights include pivotal data on KRAZATI® (adagrasib) for KRASG12C-mutant NSCLC, and CheckMate -9DW trial results on Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for advanced hepatocellular carcinoma. Long-term data for Opdualag™, Opdivo, and Breyanzi® (lisocabtagene maraleucel) will be showcased, highlighting sustained clinical outcomes. Emerging science includes efficacy and safety data for new treatments like the triplet combination of nivolumab, relatlimab, and ipilimumab for advanced melanoma, and the first results of GPRC5D-directed CAR T cell therapy for multiple myeloma. The comprehensive data reflect Bristol Myers Squibb’s commitment to advancing immuno-oncology, targeted therapies, and novel treatment modalities.

Bristol Myers Squibb (NYSE: BMY) announced data presentation at the 2024 American Society of Clinical Psychopharmacology Annual Meeting, highlighting the potential of KarXT as a novel treatment for schizophrenia. The EMERGENT-5 trial showed no significant changes in movement disorder scale scores and a low 1% incidence of treatment-related extrapyramidal symptoms (EPS). Participants reported improvements in positive, negative, and cognitive symptoms of schizophrenia.

Notable findings will include data on the low long-term risk of EPS and participant experiences with KarXT, emphasizing its safety and efficacy. Bristol Myers Squibb anticipates continuing discussions with the U.S. FDA on KarXT's potential approval.

Bristol Myers Squibb (BMY) unveiled a 10-year strategy named ASPIRE to expand access to its innovative treatments in low- and middle-income countries (LMICs). The strategy aims to reach over 200,000 patients by 2033. ASPIRE focuses on affordability and availability, ensuring 100% of BMY's marketed products have access plans. BMY is also using local brands and pathways like Direct Import and Direct-to-Institution to enhance access in LMICs. Additionally, BMY is collaborating with the Access to Oncology Medicines (ATOM) Coalition to provide Opdivo™ in select countries. The initiative aligns with BMY's commitment to health equity and its Environmental, Social, and Governance (ESG) strategy.