Approaches to systemic anticancer therapy have shifted in recent decades. The nonspecific cytotoxic agents that once dominated the oncotherapy space first gave way to more targeted agents in the 1980s and 1990s, after which advanced, novel immunotherapeutic strategies took center stage. The potential of such immunotherapies to address untreatable malignancies …
How patient-centricity embeds value and stability in LTFU studies
Phase I-III randomized controlled trials alone are not generating enough data to extrapolate conclusions and theories about therapeutics to the global population. Not all drugs demonstrate the same efficacy in the real world as shown in the clinical trials. Because of this, we are seeing a rise in long-term follow-up …
Exploring metastatic breast cancer immunotherapies: Are ADCs and ICIs the answer?
Breast cancer is the most common malignancy in women and the second most common cancer worldwide.1 Rates of breast cancer are increasing in many parts of the world, reflecting its association with social and lifestyle factors related to economic development, as well as increases in life expectancy.2 Although the disease …
Cell and Gene Therapy Answers: Bioanalytical support for cell and gene therapy
Your source for answers to the complex challenges of cell and gene therapy development. We recently spoke with Daniel Sikkema, executive director of global immunochemistry at Labcorp drug development, regarding bioanalytical support for cell and gene therapy modalities. He shared some of the current challenges in cell and gene therapy, …
Detecting measurable residual disease (MRD) in hematological malignancies using flow cytometry
A patient may be in complete remission during or after a cancer treatment, but a few cancer cells may persist in what is known as residual disease. To better inform prognoses, understand treatment decisions, predict a patient’s overall survival or understand the potential for disease relapse, it is important to …
Technologies, tools and processes to support patient-centric oncology trials
There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites. DCTs provide an opportunity …
Decentralized Clinical Trials (DCT) Monthly Blog – March 2021
This month, we want to highlight the growing connections between decentralized clinical trials (DCTs) and the critical therapeutic area of oncology.
Minimal Residual Disease by Flow Cytometry: Latest Insights on Validation
Despite the development of cellular and antibody-based therapeutics that eliminate malignant cells, patients who have achieved complete remission or response may experience relapse. Increasing evidence suggests that the presence of measurable/minimal residual disease (MRD) in bone marrow (BM) tissue is one, if not the strongest, prognostic factor for disease outcome …
Innovation in Plasma Cell Enrichment for Multiple Myeloma Studies
Syndecan-1 (SDC1), also known as CD138, is a well-known and specific plasma cell marker that is highly expressed on the surface of multiple myeloma plasma cells. As it can be a challenge detecting the small number of malignant plasma cells within the large proportion of cells obtained from a bone …
Centralized Multiple Myeloma Service Delivers on a Global Scale
As the volume of multiple myeloma clinical trials continues to grow, additional tests are being validated in an effort to benefit patients who typically have a five-year survival rate. These dynamics are driving strategies to address variability in testing procedures and data analysis. We recently met with our dedicated Multiple …