Pomalidomide

ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression in smoldering multiple myeloma, Arcellx's anito-cel showing comparable safety to Carvykti, and J&J/Legend's Carvykti improving survival outcomes. Kura Oncology's ziftomenib showed high response rates in leukemia, Eli Lilly's Jaypirca reduced disease progression risk, and Merck's zilovertamab vedotin achieved high complete response rates in lymphoma. Beam Therapeutics' BEAM-101 showed durable effects in sickle cell disease, Novo Nordisk's etavopivat reduced crises, and Bristol Myers Squibb's arlo-cel demonstrated durable responses in multiple myeloma. Galapagos' GLPG5101 showed encouraging cell therapy results, Orca Bio's Orca-T improved survival in blood cancers, and Sanofi's rilzabrutinib improved platelet response in thrombocytopenia. Regeneron's drug combo showed better disease control than Ultomiris in PNH.

Isa-RVd (isatuximab-irfc, lenalidomide, bortezomib, dexamethasone) as induction for 18 weeks, followed by autologous stem cell transplant, significantly reduced disease progression or death risk vs RVd in transplant-eligible newly diagnosed multiple myeloma patients, according to GMMG-HD7 trial data. The progression-free survival benefit was observed in most subgroups except those with WHO performance status over grade 1, high-risk cytogenetics, or R-ISS stage III disease. Isa-RVd also demonstrated deeper MRD-negative responses post-transplant compared to RVd.

GSK's Blenrep, a multiple myeloma drug, shows significant overall survival benefit in a Phase 3 study, potentially becoming a new standard of care treatment. The drug, an antibody drug conjugate targeting BCMA, demonstrated a 42% reduction in the risk of death compared to a standard regimen. Despite initial market withdrawal, new data supports its efficacy in earlier treatment lines, with ongoing FDA review expected in July.

GSK’s Blenrep, withdrawn in 2022, seeks FDA approval in combination with Velcade/dexamethasone or Pomalyst/dexamethasone for multiple myeloma patients with prior therapy. Based on DREAMM-7 and DREAMM-8 trials, Blenrep combos showed significant PFS improvements over standard-of-care, with manageable safety profiles. Expected to compete with BCMA CAR-T therapies like Carvykti and Tecvayli, Blenrep could offer simpler IV infusion benefits.

Bristol-Myers Squibb (BMY) benefits from biopharma market growth and rival AbbVie's trial setback, with BMY stock up 10.5%. CMO Samit Hirawat's $100,000 insider purchase adds confidence. BMY leads in oncology and offers a 4.39% dividend yield. Q3 earnings beat estimates, driven by Eliquis and Opdivo, with FDA approval for Cobenfy in schizophrenia. Analysts have a 'Hold' consensus on BMY stock.

FDA approves Cologuard Plus for colorectal cancer screening; advancements in breast cancer care include genomic testing; HBI0101 CAR T-cell therapy shows promise in multiple myeloma; neoadjuvant nivolumab plus chemotherapy approved for NSCLC; Belantamab mafodotin-blmf combo demonstrates efficacy in relapsed/refractory multiple myeloma.

Ciltacabtagene autoleucel (cilta-cel) reduced death risk by 45% in refractory myeloma patients compared to standard of care (SOC), with 30-month overall survival rates of 76.4% vs 63.8%. Cilta-cel also showed a 71% reduction in disease progression or death, with 30-month progression-free survival rates of 59.4% vs 25.7%. The therapy demonstrated deep responses and improved quality of life, though safety data remained consistent with previous reports.

FDA approves Sanofi's Sarclisa (isatuximab) in combination with VRd for newly diagnosed multiple myeloma patients ineligible for stem cell transplant, based on Phase 3 IMRIOZ trial showing significant reduction in disease progression risk.

FDA approves Sanofi's Sarclisa for use with Velcade, Bristol Myers' Revlimid, and dexamethasone in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant.