Darzalex, a monoclonal antibody was recently approved by the Singapore Health Sciences Authority for Multiple Myeloma patients who have become resistant to current drug therapies. Read more to find out the details.
Every day, we encounter many microorganisms and come out relatively unscathed. Thanks, to the immune system, we can go about our lives without worrying about being ambushed by microscopic Lex Luthors waiting to colonize our internal systems.
Different cell types form the Immune system. A key feature of the immune system is its ability to encounter foreign agents, neutralize the threat and form a memory of the attack. This immunological memory is contained in plasma cells that produce antibodies against the foreign agent. In the event of a second attack, the antibodies produced by B-cells effectively help to combat the infection. Even as the immune system is hard at work, some cells go rogue. This can result in conditions like autoimmune diseases and cancer.
In this article, we talk about Multiple Myeloma, a cancer of the blood characterized by uncontrollable proliferation of plasma cells in the bone marrow. Multiple myeloma accounts for approximately one percent of all cancers and 2 percent of all deaths from cancer. The annual mortality rate per 100,000 people from multiple myeloma in Asia has increased by 53.5 percent since 1990, an average of 2.3% a year
While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems such as sharp pain, low blood counts, calcium elevation, kidney problems or infections.
Attacking Multiple Myeloma
Current therapies for Multiple myeloma are classified into 6 broad categories depicted here.
This year, Janssen, a division of Johnson & Johnson Pte Ltd announced the availability of DARZALEX® (daratumumab) in Singapore as a monotherapy for the treatment of multiple myeloma patients who have received at least three prior lines of therapy and have relapsed or become resistant to other therapies. These patients typically have poor survival prognoses, with a median survival of approximately 8 months.
DARZALEX is the first CD38-directed monoclonal antibody (mAb) to be approved to treat multiple myeloma. It binds to CD38, a surface protein highly expressed in multiple myeloma cells, regardless of disease stage. DARZALEX, induces tumor cell death through apoptosis, in which a series of molecular steps in a cell leads to its death. DARZALEXTM (daratumumab) is indicated for the treatment of patients with relapsed or refractory multiple myeloma where it increases median overall survival by 20.1 months through immunomodulatory effects.
“While uncommon, multiple myeloma cancer has seen rising incidences in Singapore and Asia. The treatment and research into multiple myeloma have progressed tremendously in the last 10 years with many new drugs approved in the US and Europe. Over the longer term, we hope to contribute towards making such drugs more accessible to patients who need them” said Prof Chng Wee Joo, Centre Director, National University Cancer Institute, Singapore.
Filling a critical gap in the Multiple Myeloma field
In 2013, barely a year after Janssen Biotech, Inc, licensed daratumumab, the DarzalexTM was formed under Dr. Tahamtan Ahmadi. A doctor by training, Ahmadi’s Ph.D. in immunology made him the perfect candidate to lead the ambitious project to take DarzalexTM to those who were in dire need of it. With this goal in mind, Ahmadi and team hit the ground running. Within 2 years, in November 2015, FDA approved Darzalex TM for the treatment of multiple myeloma in patients who had received at least three of the existing drugs.Success has not made Ahmadi complacent. He is focused on discovery of drugs like to combat the new cases of Multiple Myeloma, a sentiment echoed by Dr. Alessandra Baldini
“At Johnson & Johnson, we strive to bring innovative solutions to ameliorate patients’ lives. For this reason, we are so pleased to have daratumumab now available in Singapore for patients affected by hard-to-treat cancers, such as multiple myeloma, DARZALEX – the first CD38-directed monoclonal antibody – is a great example of this commitment to patients and healthcare providers alike. We will continue to study this compound as both a mono- and a combination therapy across all key stages of the disease to understand its full clinical benefit for patients in need”, said Dr.Alessandra Baldini, Singapore Medical Affairs at J&J Singapore.
The slew of approvals for DarzalexTM for monotherapy and combination in different disease settings such as frontline and relapsed cases have come through even as industry experts fear an approaching mad rush to find the best cocktail. Experts suggest that immunomodulatory drugs work best in combination with other drug classes. This has spawned numerous trials on DarzalexTM in combination with other drug classes. Regulators across the board believe that there must be greater scrutiny for trials involving immunomodulatory drugs as these have biological effects that may be far more serious than the toxicity issues that are frequently the focus of attention.
For more information, read our interview with Prof. Professor Chng Wee Joo MB ChB, Ph.D., FRCP (UK), FRCPath (UK), FAMS.Prof Chng is the Centre Director of the National University Cancer Institute, Singapore (NCIS).
Illustrations by Ananya Pal