The Current State of Triple-Negative Breast Cancer Trials

The growing prevalence in the Asia-Pacific region of triple-negative breast cancer (TNBC) signifies a shift toward a more inclusive and globally balanced research landscape, says Sarah Anderson, oncology strategy lead director, Novotech.

This transcript has been lightly edited for clarity; captioning was auto generated.

Transcript

What accounts for the growing prominence of the Asia-Pacific region in TNBC clinical trials, and how might this shift influence global research priorities?

So, the growing prominence in the APAC [Asia-Pacific] region and triple-negative breast cancer trials can really be contributed to several key factors. First, the region itself offers access to a large, diverse patient population, which is critical for understanding the disease across varying genetic and environmental contexts. With breast cancers, the incidences arise between China and India, for which research has really surged, and there is definitely a need for patients and investigators.

Additionally, within the APAC region, we have definitely seen significant investments in health care infrastructure also, and biotech over the past decade. Governments in countries such as Japan, South Korea, [and] Singapore have introduced policies to support clinical trials, while also reducing operational costs to make the regions much more attractive for trials. Ultimately, I would say, the growing prevalence in the APAC region for triple-negative breast cancer has definitely signified a shift toward a more inclusive and globally balanced research landscape, accelerating the fight of triple-negative breast cancer and other cancers in this region.

How are novel biomarkers such as BRCA1/2 mutations, PD-L1 expression, and FGFR amplifications driving the development of precision therapies, and what potential do they hold for improving patient outcomes?

When we think about triple-negative breast cancer, [it’s] a particularly aggressive form of breast cancer. Triple-negative breast cancer lacks the expression of estrogen, progesterone and HER2 receptors, and so it makes it unresponsive for standard hormonal therapies targeting HER2. With the emergence of novel biomarkers such as BRCA1 mutations, PD-L1 expressions, and FGFR amplifications, these have been pivotal in driving the development of therapies. So, when we think about the BRCA1/2 mutation, these are one of the most well-known, well-studied biomarkers in triple-negative breast cancer. When we think about the BRCA mutations, these mutations disrupt the DNA repair pathway, leveraging cancer cells that are vulnerable to therapies within this area.

In addition, PARP [poly-ADP-ribose polymerase] inhibitors have demonstrated significant efficacy in patients with BRCA-mutated triple-negative breast cancer, offering a targeted approach that's minimizing the damage to healthy cells.

When we take this a step further, and we think about this from the PD-L1 expression, this has opened the door for immunotherapies within triple-negative breast cancer. Immune checkpoint inhibitors target specifically the PD-L1 protein, which helps evade the immune system. By blocking this pathway, these therapies reinvigorate immune cells, enabling them to attack more cancers effectively. This approach here with PD-L1 expression has shown promise, particularly in the advancement of triple-negative breast cancer therapies, where, more often, the options for patients have been limited.

Coming into the FGFR amplification. So, this is another promising target. It is definitely a newer target. The FGFR signaling pathways are implicated in tumor growth and survival. FGFR inhibitors are being proactively and actively explored in trials, with the potential of offering tailored therapies for patients whose tumors exhibit these genetic alterations. Within these early stages, compared to BRCA1- and PD-L1–focused therapies, FGFR-targeted therapies hold significant promise for addressing treatment option resistance and including enhancing outcomes.