ClinicalTrials.gov recorded primary completion on 6 November 2024 for a Phase 3 Japan extension study of subcutaneous pembrolizumab formulated with berahyaluronidase alfa versus intravenous pembrolizumab in adults with metastatic non-small cell lung cancer. The trial enrolled 39 participants and reported pharmacokinetic measurements and objective response rates for both treatment approaches.

Background

The study evaluated pembrolizumab, also known as Keytruda, given subcutaneously in a formulation with berahyaluronidase alfa, compared with pembrolizumab administered intravenously. Both approaches were used with platinum doublet chemotherapy as first-line treatment for adult Japanese participants with metastatic non-small cell lung cancer. The registered chemotherapy interventions included pemetrexed, cisplatin, carboplatin and paclitaxel.

Trial design

This was a Phase 3 study identified as NCT06212752. It enrolled 39 participants with metastatic non-small cell lung cancer and was listed as active, not recruiting. The study assessed pharmacokinetics and safety, with a primary hypothesis that subcutaneous pembrolizumab plus berahyaluronidase alfa would be noninferior to intravenous pembrolizumab for pharmacokinetic parameters. The supplied record did not list primary outcome entries.

Key results

Objective response rate was 64.3% in the subcutaneous pembrolizumab plus platinum doublet chemotherapy arm and 18.2% in the intravenous pembrolizumab plus platinum doublet chemotherapy arm. The record labeled the dispersion as a 95% confidence interval but did not provide interval values for these response measurements.

After the first dose, cycle 1 pembrolizumab AUC from 0 to 6 weeks was 1,864.76 µg·day/mL with subcutaneous treatment, with a geometric coefficient of variation of 22.18, versus 1,697.98 µg·day/mL and 18.50 with intravenous treatment. Cycle 3 steady-state trough concentration was 45.11 µg/ml versus 30.86 µg/ml, respectively.

Cycle 1 maximum concentration was 71.54 µg/ml for subcutaneous treatment and 141.9 µg/ml for intravenous treatment. Cycle 1 trough concentration was 23.62 µg/ml and 16.27 µg/ml, respectively. At cycle 3 steady state, AUC from 0 to 6 weeks was 3,116 µg•day/ml with subcutaneous treatment and 2,514 µg•day/ml with intravenous treatment.

The registry also listed two analyses with no linked outcome title or method: a geometric mean ratio of 1.1 with a 95% confidence interval of 0.95–1.27, and a GMR of 1.46 with a 95% confidence interval of 1.14–1.88.

What this means

The reported data provide a pharmacokinetic comparison of subcutaneous and intravenous pembrolizumab in this Japanese metastatic NSCLC study, alongside numerically different response rates. The supplied record does not include p-values, a safety summary, or enough detail to identify which outcomes correspond to the two GMR analyses. These results do not establish a new approval or indication.

Source

Source: ClinicalTrials.gov, trial record for NCT06212752, dated 6 November 2024. The record is available at clinicaltrials.gov/study/NCT06212752.