Samsung Bioepis SB27 Matches Keytruda in Phase 3 Trial

Samsung Bioepis said Monday that SB27, its biosimilar version of Merck's blockbuster cancer drug Keytruda, hit its primary endpoints in both a Phase 1 and a Phase 3 trial. The Phase 3 study enrolled 555 patients with metastatic non-squamous non-small cell lung cancer. The objective response rate at week 24 for SB27 fell within the prespecified equivalence margin when compared with the reference product.

The 90% confidence interval for the response-rate ratio ran from 0.737 to 1.071. Regulators had set the equivalence boundary at 0.712 to 1.405. The result clears the bar for demonstrable similarity, the company said.

Phase 1 data showed pharmacokinetic bioequivalence. The study randomized 163 patients with stage II or IIIA NSCLC who had completed surgery and platinum-based chemotherapy. SB27 was measured against both EU-sourced Keytruda and US-sourced Keytruda. Blood samples collected every three weeks for up to 51 weeks produced exposure numbers, measured by area under the curve, that met the predefined equivalence criteria.

"We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27," said Donghoon Shin, executive vice president and head of the clinical sciences division at Samsung Bioepis. "We are on track to complete both Phase 1 and Phase 3 studies within this year." Shin added that the company would work toward regulatory filings to expand access to the drug.