Samsung Bioepis' 'SB27' Demonstrates Equivalence to Keytruda in Phase 3 Trial

Study involved 555 patients with non-small cell lung cancer
Similar survival and safety outcomes

Samsung Bioepis has presented the global Phase 3 clinical trial results for SB27 (generic name: pembrolizumab), a biosimilar of Keytruda, the world’s top-selling drug, at an international conference. SB27 showed efficacy equivalent to the original drug on key endpoints, as well as similar results in survival and safety.

A Samsung Bioepis representative (left) explains the Phase 3 global clinical trial results for SB27, a Keytruda biosimilar, at the Society for Immunotherapy of Cancer (SITC 2026) conference in Phoenix, Arizona, on the 6th. Samsung Bioepis

Samsung Bioepis said it presented the Phase 3 results for SB27 at the Society for Immunotherapy of Cancer (SITC 2026) conference, held in Phoenix, Arizona, from November 4 to 8 (local time). The clinical trial, which began in 2024, enrolled 555 patients with metastatic nonsquamous non-small cell lung cancer across 14 countries. Patients received either SB27 or the original Keytruda alongside standard chemotherapy.

The primary endpoint, the objective response rate (ORR) at 24 weeks, met the equivalence criteria set by regulatory authorities. The results were also similar to those for the original drug on secondary endpoints, including progression-free survival (PFS), the period during which the cancer does not progress; duration of response, the period during which a treatment response is maintained; and overall survival (OS). The rates of adverse events and serious adverse events were also similar to those for the original drug, and no neutralizing antibodies that could reduce efficacy were detected.

Keytruda is an immuno-oncology drug developed by U.S. pharmaceutical company MSD. It binds to PD-1, an immune checkpoint receptor, suppressing cancer cells’ ability to evade the immune system and activating the body’s immune cells to help attack the cancer cells. Global sales last year totaled approximately $31.7 billion (about KRW 46 trillion). Samsung Bioepis was the first company in South Korea to apply to the Ministry of Food and Drug Safety for approval of SB27 in August, and it filed for approval in the United States last month, ahead of its competitors.

Shin Donghun, Head of Clinical Sciences at Samsung Bioepis and a vice president, said, “In a large-scale global Phase 3 clinical trial, we demonstrated that SB27 met the primary endpoint and confirmed its clinical equivalence to the original drug, along with consistent safety. We will focus our development capabilities on improving patient access to high-quality cancer biologics.”

This content was produced with the assistance of AI translation services.