BRISTOL MYERS SQUIBB

Interim analysis of CheckMate 8HW trial shows nivolumab plus ipilimumab prolonged progression-free survival vs chemotherapy in MSI-H/dMMR metastatic colorectal cancer patients without prior systemic therapy. Median progression-free survival not reached in nivolumab/ipilimumab group vs 5.9 months in chemotherapy group (P < .001). Grade 3/4 adverse events occurred in 23% vs 48% of patients, with treatment-related deaths in two nivolumab/ipilimumab patients.

TRANSCEND CLL 004 study data showed Breyanzi with Imbruvica achieved 86% response rate and 45% complete remission in relapsed/refractory CLL/SLL patients. Breyanzi, first CAR T therapy for CLL, targets unmet need in patients failing BTK and BCL2 inhibitors. Breyanzi sales projected to reach $2.6 billion by 2030.

ICER's review found 5 of the 10 highest-priced U.S. drugs lacked new clinical evidence to justify price increases, costing payers $815M in 2023. ICER uses the GRADE approach to assess evidence quality, focusing on new, moderate- to high-quality evidence. Some drugs, like Keytruda, Imfinzi, and Opdivo, had price increases supported by new evidence from randomized control trials.

The regenerative medicine market is projected to grow from USD 41.3 billion in 2023 to USD 194.9 billion by 2032, driven by chronic diseases, stem cell therapy advancements, and government support. Key developments include FDA approvals for CAR T-cell therapies and partnerships in gene therapy for eye diseases.

The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.

Precision medicine tailors CVD treatments to patient subgroups based on unique genetic traits, improving clinical outcomes and quality of life, leveraging insights from hypertrophic cardiomyopathy.

2024 saw significant advancements in skin cancer treatment, including FDA approvals for lifileucel and IBI363, new clinical guidelines for nonmelanoma skin cancer, an updated PDUFA date for subcutaneous nivolumab, and 3-year data for mRNA-4157 combined with pembrolizumab.

The global synthetic biology market was valued at USD 10.7 billion in 2021 and is projected to grow at a CAGR of 21.3% to reach over USD 74.7 billion by 2031, driven by advancements in biotechnology, applications in healthcare, agriculture, and energy, and demand for sustainable solutions. Key players include Bristol-Myers Squibb, Gevo, Inc., Life Technologies, and others. Challenges include regulatory issues, ethical concerns, high R&D costs, and technical challenges, while opportunities lie in sustainable solutions, personalized medicine, and bio-based products.

ASH meeting featured studies on BTK inhibitors in CLL, including Jaypirca's Phase 3 trial showing improved progression-free survival and fewer side effects. AstraZeneca's Calquence combined with Venclexta reduced progression risk by 35%. Pfizer's Oxbryta withdrawal due to safety concerns raised questions on sickle cell drug approvals. Bristol Myers Squibb presented positive survival data for its GPRC5D-targeted CAR-T therapy, arlo-cel, in multiple myeloma.