Odronextamab

Odronextamab combinations may help elicit responses in DLBCL patients after CAR T-cell therapy failure. Duration of prior CAR T-cell therapy benefit predicts bispecific antibody response. Developing combination approaches with odronextamab aims to mitigate disease progression and elicit responses.

Odronextamab showed a manageable safety profile with primarily grade 1 or 2 cytokine release syndrome (CRS) in DLBCL patients, no grade 5 CRS or immune-effector cell-associated neurotoxicity syndrome (ICANS) cases, and 20% grade 3 or greater infection rate. A treatment-related death occurred due to COVID-19 pneumonia. The CAR-HEMATOTOX model identified patients at higher risk for infectious complications.

Regeneron's Ordspono shows promise in treating r/r MZL with 77.1% ORR and CR rate, but faces challenges like low long-term adherence and regulatory delays. It received EU approval for r/r FL and DLBCL, but US market adoption is pending confirmatory trials. Competitors like AbbVie and Genmab's Epkinly pose threats with more convenient administration routes.

Odronextamab showed 100% complete response in untreated follicular lymphoma, 48% objective response in DLBCL post-CAR-T, and 77% complete response in relapsed/refractory marginal zone lymphoma. EU approval secured; U.S. resubmission planned for 2025.

New data for odronextamab presented at ASH 2024 show potential in earlier lines of treatment and additional types of lymphoma, including complete responses in follicular lymphoma and durable responses in diffuse large B-cell lymphoma progressing after CAR-T therapy.

Oral and poster presentations on various studies in hematology, including outcomes with bispecific T-cell engagers, phase 1 results of menin-MLL inhibitors, and real-world outcomes of CAR T-cell therapy, among others, scheduled for December 7-9, 2024.

Q3 2024 revenues up 11% to $3.72 billion; Dupixent global net sales by Sanofi up 23% to $3.82 billion; U.S. net sales for EYLEA HD and EYLEA up 3% to $1.54 billion; Libtayo global net sales up 24% to $289 million; GAAP diluted EPS up 30% to $11.54; FDA approves Dupixent for COPD and eosinophilic phenotype; positive results for Dupixent in CSU and BP trials.

B-NHL is a complex group of malignancies with distinct subtypes, including DLBCL and FL, each requiring specific management. BiTEs like glofitamab, epcoritamab, mosunetuzumab, and odronextamab offer novel treatment options for R/R B-NHL, each with unique characteristics influencing their selection based on factors such as treatment duration, cost, administration route, and patient considerations.

Q3 2024 saw approval of 5 novel antibody drugs, increased ADC research, and $3B in collaborations. Investment in antibodies continues, with startups raising up to $370M. Promising antibodies for Q4 include treatments for genetic disorders and cancers.

Regeneron's Libtayo showed durable survival benefits in advanced NSCLC, with median OS of 26 months vs. 13 months for chemotherapy, and no new safety signals observed at five years.