In a recent news release, biopharmaceutical companies AbbVie, Inc. and SpringWorks Therapeutics, Inc. (“SpringWorks”) shared that the two had entered into a joint clinical trial collaboration agreement. Through this collaboration, AbbVie and SpringWorks will evaluate a combination treatment of nirogacestat and ABBV-383 for people with relapsed or refractory (R/R) multiple myeloma (MM). Hopefully, this collaboration can create new therapeutic options for patients to improve quality of life (QOL) and overall patient outcomes.
Nirogacestat
To begin, let’s dig into what exactly these therapies are. ABBV-383 (TNB-383B) is described by AbbVie as:
a BCMA x CD3 T-cell engaging bispecifc antibody being studied in relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy.
Alternately, nirogacestat is described by SpringWorks as an investigational, orally-administered small molecule gamma-secretase inhibitor. Outside of multiple myeloma, SpringWorks is evaluating nirogacestat for the treatment of desmoid tumors. Researchers believe that inhibiting gamma-secretase stops BCMA from shedding from myeloma cell surfaces. In this sense, the treatment works to improve BCMA activity and reduce tumor and cancer activity.
So far, nirogacestat has received Fast Track, Breakthrough Therapy, and Orphan Drug designations within the United States. Additionally, the treatment also received Orphan Drug designation in Europe for soft tissue sarcoma (STS).
In this new collaboration, AbbVie will offer sponsorship for a Phase 1b clinical trial. During the trial, researchers will explore the safety, efficacy, and tolerability of nirogacestat and ABBV-383 for patients with R/R MM.
Multiple Myeloma (MM)
Multiple myeloma is a rare cancer which forms in plasma cells, a type of white blood cell that usually plays a role in fighting infections. Normally, plasma cells create antibodies which recognize and attack foreign invaders in the body. But in patients with multiple myeloma, abnormal and cancerous cells crowd healthy blood cells out of bone marrow, making it more difficult to fight infection. Multiple myeloma is also characterized by high levels of M proteins, a type of abnormal antibody, within the blood. While doctors are not sure what causes multiple myeloma, some patients are missing all or part of chromosome 13.
Symptoms associated with multiple myeloma include:
- Appetite loss
- Frequent or recurrent infections
- Unintended weight loss
- Bone pain which may be worse in the spine or chest
- Nausea
- Fatigue
- Bone fractures
- Weakness or numbness in the legs
- Excessive thirst and frequent urination
- Constipation
- Mental confusion
- Hypercalcemia (excess calcium levels)
