Drugs Xagena
Data for Odronextamab in patients with relapsed / refractory ( R/R ) follicular lymphoma ( FL ) from a pivotal phase 2 trial ( ELM-2 ) were presented at the 65th American Society of Hematology ( ASH ) Annual Meeting.
These data have included updated efficacy, safety and patient-reported outcomes ( PROs ).
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
Longer-term data from the phase 2 Odronextamab trial continued to confirm high rates of durable responses in patients with relapsed / refractory follicular lymphoma.
At a prespecified interim analysis that occurred when the first 80 patients had greater than or equal to 12 months of follow-up, results among 128 patients that were assessed by independent central review ( ICR ) have demonstrated: 80% objective response rate ( ORR ), with 73% achieving a complete response ( CR ); median duration of response ( DoR ) was 23 months ( 95% confidence interval [ CI ]: 17 months to not estimable [ NE ] ) and median duration of complete response was 24 months ( 95% CI: 18 months to NE ) with a 18-month median duration of follow-up for efficacy evaluable patients ( 95% CI: 15 to 28 months ); median progression-free survival ( PFS ) in complete responders was 28 months ( 95% CI: 20 months to NE ) and 21 months for all patients ( 95% CI: 17 to 28 months ); median overall survival ( OS ) was not reached ( 95% CI: 32 months to NE ).
The most common adverse events occurring in greater than or equal to 30% of patients were cytokine release syndrome ( CRS; 56% ), neutropenia ( 48% ), pyrexia ( 36% ), anemia ( 34% ), COVID-19 ( 31% ) and infusion-related reactions ( 31% ).
In 60 patients that received the recommended step-up regimen, 57% experienced cytokine release syndrome. All cases were resolved with supportive measures, with a median duration of 2 days ( range: 1 to 10 days ). Among these patients, 45% ( n=27 ) had grade 1 cytokine release syndrome, 10% ( n=6 ) had grade 2 CRS, and 2% ( n=1 ) had grade 3 CRS.
There was one grade 2 immune effector cell-associated neurotoxicity syndrome event reported, which was not associated with cytokine release syndrome.
Patients with relapsed / refractory follicular lymphoma treated with Odronextamab in the ELM-2 trial completed three validated questionnaires aimed at measuring health-related quality of life ( HRQoL ), functioning and symptoms. Pre-specified analyses were conducted across six scales. Overall, patients reported generally good HRQoL, functioning and low symptom burden at baseline as assessed across several scales.
Key findings through week 50 have shown: overall maintenance of moderate to high levels of functioning and HRQoL without detriments to patient-reported symptoms based on an analysis of changes in PRO scores from baseline over time, as measured by EORTC QLQ-C30 ( European Organization for Research and Treatment of Cancer Quality of Life Questionnaire ) scores; median time to definitive deterioration in physical function and lymphoma-specific symptoms was not reached ( per EORTC QLQ-30 and FACT-Lym [ Functional Assessment of Cancer Therapy Lymphoma ] subscale, respectively ).
In an individual patient-level analysis, more patients have reported maintenance or clinically meaningful improvement in physical functioning and lymphoma-specific symptoms than deterioration at each assessment.
One of the most common subtypes of B-cell non-Hodgkin lymphoma ( B-NHL ), follicular lymphoma is a slow-growing ( indolent ) form of B-NHL, with most cases diagnosed in advanced stages. Although median survival ranges from 8 to 15 years in advanced follicular lymphoma, current therapeutic options are not curative, and most patients relapse within five years, regardless of the regimen.
In the U.S., it is estimated that approximately 13,100 people will be diagnosed with follicular lymphoma in 2023.
In some cases, follicular lymphoma can transform into diffuse large B-cell lymphoma ( DLBCL ), at which point it is often treated in the same way as DLBCL. ( Xagena )
Source: Regeneron Pharmaceuticals, 2023
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