Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma - Seite 2

In addition, high ORRs were observed across prespecified subgroups – including high-risk and high-disease burden populations – as follows:

• 85% among Black or African American patients (17 of 20 patients)
• 71% among those aged 75 years or older (22 of 31 patients)
• 67% among those with high cytogenetic risk (31 of 46 patients)
• 62% among those with International Staging System stage III disease (13 of 21 patients)
• 53% among those with extramedullary plasmacytomas (10 of 19 patients)
  

Cytokine release syndrome (CRS) was the most commonly occurring treatment-emergent adverse event (TEAE) and was observed in 46% of patients; 35% were Grade 1, 10% were Grade 2 and one case (1%) was Grade 3. Adjudicated immune effector cell-associated neurotoxicity syndrome (ICANS) events of any grade occurred in 8% of patients, including three cases that were Grade 3 and no cases that were ≥Grade 4. Infections occurred in 73% of patients, with their frequency and severity decreasing after 6 months; 34% were Grade 3 or 4. The most common Grade 3 or 4 TEAEs (≥20%) were neutropenia (40%) and anemia (31%). Six deaths occurred on treatment or within 30 days of the last treatment dose due to TEAEs; five were due to infection, and one was due to renal failure.

Linvoseltamab has been granted Fast Track Designation and was accepted for Priority Review for the treatment of R/R MM by the FDA, with a target action date of August 22, 2024. In addition, linvoseltamab is being reviewed by the EMA. Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

The Phase 3 confirmatory trial for linvoseltamab in patients with R/R MM (LINKER-MM3) is underway.

About Multiple Myeloma
As the second most common blood cancer, there are over 176,000 new cases of MM diagnosed globally, and 35,000 cases are diagnosed in the U.S. every year. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.