Will teclistamab soon be available for patients with multiple myeloma within the European Union? According to OncLive, approval seems to be on the horizon. Following results from the Phase ½ MajesTEC-1 clinical trial, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) adopted a positive opinion and recommended that teclistamab be approved. This opinion means that an approval is burgeoning, which would soon allow patients with multiple myeloma to receive a new therapeutic option. 

Teclistamab would offer a potential treatment route for those with treatment-averse cancer. The therapy is designed for those who have treated their cancer with three or more other treatments – though none of these could be BCMA-directed therapies. 

Evaluating Teclistamab: the MajesTEC-1 Study

In a June 2022 news release, teclistamab is described as: 

an investigational, fully humanized IgG4, T-cell redirecting, bispecific antibody targeting both BCMA (B-cell maturation antigen which is expressed at high levels on multiple myeloma cells) and CD3, the T-cell receptor. Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.

In the United States, teclistamab has received both Orphan Drug and Breakthrough Therapy designations. Alternately, teclistamab has received Orpahn Drug and PRIME designations in the European Union. 

Within the MajesTEC-1 clinical trial, researchers evaluated the safety, tolerability, and overall response rate of teclistamab for those with multiple myeloma. 89.7% of participants were refractory to prior treatment options. Those within the trial had used an average of five prior therapies before enrollment. Findings from the study show that:

• 58.8% of participants experienced a partial response, with 39.4% experiencing a complete response. 
• It typically took around 1.2 months to achieve any sort of response, with the best response peaking at around 3.8 months following treatment. 
• The average progression-free survival was 11.3 months. 
• 100% of those within the trial experienced some sort of adverse reaction, with a high number of these being Grades 3 or 4. 
• For those with any sort of adverse reaction, the most common forms were cytokine release syndrome, diarrhea, fatigue, nausea, and low platelet, red blood cell, neutrophil, and lymphocyte counts. 

About Multiple Myeloma (MM)

Multiple myeloma (MM) is a rare cancer which forms in plasma cells, a type of white blood cell which usually plays a role in antibody creation and infection fighting. However, in those with multiple myeloma, the abnormal plasma cells accumulate in bone marrow. They crowd out healthy blood cells, causing a number of negative health impacts. Additionally, these abnormal cells produce too many abnormal antibodies called M proteins. While doctors are unsure what causes multiple myeloma, many myeloma cells are found to be missing part or all of chromosome 13. Though not an exhaustive list, symptoms can include:

• Frequent or recurrent infections
• Unintended weight loss
• Appetite loss
• Fatigue
• High blood calcium levels
• Excessive thirst
• Confusion or “brain fog”
• Nausea
• Constipation
• Bone pain, particularly affecting the chest and/or spine
• Leg weakness or numbness