AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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.

The global oncology-based in-vivo CRO market was valued at USD 1.4 billion in 2024 and is expected to grow at an 8.8% CAGR from 2025 to 2034, driven by demand for immuno-oncology therapies, advancements in in-vivo models, and growing oncology drug approvals from small biotech and pharmaceutical companies. Small firms lead in oncology drug approvals, focusing on innovative treatments like CAR-T cell therapy and monoclonal antibodies. The market is segmented by service, model, end use, and region, with preclinical testing dominating. Key trends include the rise of immunotherapies, outsourcing by biotech firms, AI integration, and strategic alliances between companies and CROs.

Obesity rates in the U.S. have slightly dropped to about 40%, linked to 13 cancers. Studies suggest weight-loss medicines like semaglutide may lower cancer risk. Dana-Farber researchers are testing interventions combining diet, exercise, and novel medicines to reduce cancer risk, focusing on specific high-risk groups.

Theratechnologies reports favorable tolerability and efficacy signals for sudocetaxel zendusortide in Phase 1b trial for advanced ovarian cancer, with no dose-limiting toxicities and significant tumor shrinkage observed.

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.

ASCO calls for prioritizing health equity and SDOH data in pediatric clinical trials to improve cancer treatment and survivorship. Recommendations include federally and privately funded embedded SDOH data collection and optional, embedded social needs interventions in COG protocols.

GSK's DREAMM-7 trial shows belantamab mafodotin reduces death risk by 42% in multiple myeloma post-first relapse, with projected median OS of 84 months vs 51 months for daratumumab combination, and 3-year OS rate of 74% vs 60%. Therapy under regulatory review in seven major markets.

Lenvatinib plus gefitinib achieved ORR of 16.7% based on RECIST1.1 and 30% based on mRECIST in HCC patients, showing promise despite resistance mechanisms and study limitations.

NMPA accepted GSK's NDA for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on DREAMM-7 trial results showing significant efficacy, including overall survival. This marks the seventh major regulatory filing acceptance for belantamab mafodotin combinations this year.

Zanidatamab-hrii (Ziihera), a HER2-targeting bispecific antibody, is now a category 2A treatment option in NCCN guidelines for biliary tract cancer (BTC). FDA accelerated approval was based on HERIZON-BTC-01 trial results showing a 52% ORR and 14.9 months DOR. The trial enrolled 62 HER2+ BTC patients previously treated with gemcitabine. Updated results at 2024 ASCO showed median OS of 15.5 months, with higher rates in HER2 IHC 3+ patients. Zanidatamab inhibits tumor growth through multiple mechanisms and is the first chemotherapy-free option for BTC. Common AEs included diarrhea, infusion-related reactions, abdominal pain, and fatigue, with manageable safety profile. Ongoing trials aim to validate benefits and explore zanidatamab in other HER2-expressing cancers.