GILEAD SCIENCES SL

To end the HIV epidemic, integrating social determinants of health and person-centered care is crucial. Despite biomedical advances, challenges like treatment access and drug resistance persist. Tailored treatments and advancing health equity through community involvement and partnerships are essential for long-term success and achieving UNAIDS 2030 goals.

ASCO's annual meeting highlights include BMS's Opdivo/Yervoy combo showing promise in liver cancer, Sanofi's Sarclisa combo reducing multiple myeloma progression, BMS's Breyanzi efficacy in lymphoma, and AstraZeneca's Enhertu improving breast cancer PFS. Other notable updates include GSK's Blenrep in myeloma, AstraZeneca's Imfinzi in lung cancer, and Pfizer/Takeda's Adcetris in Hodgkin lymphoma.

FDA approved Gilead Sciences’ Sunlenca (lenacapavir) for treating multi-drug resistant HIV-1 in heavily treated adults. It's a twice-yearly treatment with a unique mechanism, costing $42,250 initially, then $39,000 annually. Sunlenca, a capsid inhibitor, offers a new option for patients with limited therapy choices, supported by CAPELLA trial data showing significant viral load reduction and CD4 count increase.

The CheckMate 8HW trial showed nivolumab plus ipilimumab significantly reduced disease progression or death risk by 79% in MSI-H/dMMR metastatic colorectal cancer patients, compared to chemotherapy. With a 24-month progression-free survival rate of 72% vs 14%, and fewer severe adverse events, this immunotherapy combination may offer a new first-line treatment option.

FDA approved Gilead Sciences' remdesivir as the first fully approved treatment for COVID-19, despite WHO findings of minimal impact on mortality. Gilead faced criticism for high pricing and profit motives. Japan also approved remdesivir, highlighting global efforts to combat the pandemic with antiviral treatments.

A U.S. COVID-19 patient was treated with remdesivir, marking the first such treatment in the U.S. A clinical trial has begun, with the first participant being a quarantined American from the Diamond Princess. Remdesivir's effectiveness remains uncertain without comparative data. Health officials urge public preparation for significant disruptions due to COVID-19 spread.

Christopher Ma, Brian Feagan, Vipul Jairath, Reena Khanna, Parambir S. Dulai, and William J Sandborn disclose various financial relationships with pharmaceutical companies and research organizations, including grants, personal fees, and other forms of compensation, outside their submitted work. Robert Battat and Parambir S. Dulai report no conflict of interest.

A multicenter retrospective analysis evaluated combination systemic therapies in 253 nccRCC patients from 2012-2024. Results showed limited antitumor activity, with differential responses among nccRCC subsets based on regimen type. Optimal nccRCC management remains an unmet need, highlighting the necessity for further research.

Myelofibrosis (MF) is a severe myeloproliferative neoplasm characterized by dysregulated JAK/STAT signaling, leading to symptoms like splenomegaly and anemia. Ruxolitinib, a JAK1/JAK2 inhibitor, is approved for MF treatment, improving spleen size and symptoms but not reversing bone marrow fibrosis. Ongoing research explores combination therapies and new agents targeting anemia and fibrosis.

CAR-T cell therapy, a groundbreaking immunotherapy, modifies patient T-cells to target and destroy cancer cells, acting as 'living drugs.' With 11 products commercialized, including 7 FDA-approved, the therapy shows promise in treating blood cancers. Challenges include expanding to solid tumors, reducing 'vein-to-vein' time, and improving reimbursement. The industry is advancing through gene-transfer techniques, partnerships, and 'on-off' switches in CAR-T cells to enhance efficacy and safety.