The Study Design

The NCT04886804 study is divided into two parts to investigate BI 1810631's safety and efficacy in different patient groups. The first part is open to adult patients with various advanced solid tumors exhibiting changes in the HER2 gene. These participants had experienced treatment failures with prior therapies. The primary objective of this stage is to determine the highest tolerable dose of BI 1810631 that patients can handle.

Once the optimal dose is established, the second part of the study focuses on patients with non-small cell lung cancer (NSCLC) specifically harbouring exon20 insertions. In this phase, the researchers aim to evaluate whether BI 1810631 can induce tumor shrinkage, potentially providing a much-needed treatment option for this specific subset of patients.

Administration and Monitoring

Participants in the NCT04886804 trial received BI 1810631 orally in the form of tablets. The medication can be taken once or twice daily, depending on the treatment regimen assigned to each patient. Since BI 1810631 has been administered to patients for the first time in this study, careful monitoring of participants' health and tumor response is essential.

Patients will remain in the study for as long as they continue to benefit from and tolerate the treatment. Regular health checks and tumor assessments are being conducted by study doctors to closely monitor patients' progress. Additionally, any adverse effects attributed to BI 1810631 are diligently recorded and analyzed.

Promising Results

The interim analysis of the NCT04886804 study has shown promising outcomes. Dr. Frans Opdam, the study principal investigator, shares that in patients with non-small cell lung cancer with specific exon20 insertions, the response rate has been 46%, with a median duration of response close to 7 months. Furthermore, patients with other tumor types exhibiting HER2 amplification/overexpression or mutations have displayed a commendable response rate of 37%.

Moreover, BI 1810631 has been well-tolerated by the participants, with grade 1 diarrhea being the most common side effect reported. The ability to minimize debilitating side effects is crucial in enhancing patients' quality of life and compliance with treatment.

Future Implications

These early results from the NCT04886804 study have generated significant enthusiasm among oncologists and the medical community. The potential for BI 1810631 to become a highly effective and well-tolerated treatment option for patients with advanced HER2-altered solid tumors, including non-small cell lung cancer, is bringing us great hope.

Nonetheless, while these findings are highly encouraging, it is important to acknowledge that the study is still in its early phases, and further research and larger patient cohorts are required to validate the efficacy and safety of BI 1810631.