A Phase 3 study evaluating pembrolizumab plus epacadostat for metastatic renal cell carcinoma (mRCC) completed its primary phase on 2018-08-22, with results posted on ClinicalTrials.gov. The trial reported an objective response rate (ORR) of 31.3% for the combination therapy compared to 29.2% for standard of care.
Background
The study investigated pembrolizumab (Keytruda) in combination with epacadostat for participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component. The trial aimed to compare this combination against standard of care, which included sunitinib or pazopanib, in patients who had not received prior systemic therapy for their mRCC.
Trial design
The Phase 3 study (NCT03260894), known as KEYNOTE-679/ECHO-302, enrolled 129 participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component. The trial's purpose was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants who had not received prior systemic therapy for their mRCC.
Key results
The trial reported objective response rates (ORR) and safety data:
- For Objective Response Rate (ORR), one measurement showed 1.6% of participants in the pembrolizumab + epacadostat arm achieved an objective response, compared to 0.0% in the Standard of Care (SoC) arm.
- Another ORR measurement indicated 29.7% for the pembrolizumab + epacadostat arm and 29.2% for the SoC arm.
- A third ORR measurement showed 31.3% for the pembrolizumab + epacadostat arm and 29.2% for the SoC arm.
- Regarding safety, 64 participants in the pembrolizumab + epacadostat arm experienced adverse events, compared to 63 participants in the SoC arm.
- 8 participants in the pembrolizumab + epacadostat arm discontinued study drug due to adverse events, while 6 participants in the SoC arm discontinued.
What this means
The completion of this Phase 3 study provides initial efficacy and safety data for pembrolizumab plus epacadostat in previously untreated metastatic renal cell carcinoma. Objective response rate measurements included one showing 31.3% for the combination versus 29.2% for standard of care. However, the presented data does not include statistical significance to determine if these differences are clinically meaningful. Safety data indicates adverse events were experienced by a similar number of participants in both the combination arm (64 participants) and the standard of care arm (63 participants), with slightly more discontinuations due to adverse events in the combination arm (8 participants vs 6 participants). Clinicians will need to consider further detailed analyses to assess the potential role of this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03260894, titled "Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)", were posted on 2018-08-22 on clinicaltrials.gov.