Samsung Bioepis has confirmed the clinical equivalence of its Keytruda biosimilar in a global Phase 3 trial. The results showed similar survival rates and safety profiles compared to the original drug.
On November 9, Samsung Bioepis announced that its Keytruda biosimilar candidate, SB27 (active ingredient: pembrolizumab), demonstrated clinical equivalence to the original drug in a global Phase 3 trial. The findings were presented at the annual meeting of the American Society for Immunotherapy of Cancer (SITC 2026), held from November 4 to 8 in Phoenix, Arizona.
The trial, which began in 2024, involved 555 patients with metastatic non-small cell lung cancer across 14 countries. Participants received either SB27 or Keytruda alongside standard chemotherapy.
The primary endpoint, the objective response rate (ORR) at 24 weeks, met the equivalence criteria set by regulatory agencies. Secondary endpoints, including progression-free survival (PFS) and duration of response and overall survival (OS), were also comparable to the original drug.
Progression-free survival refers to the duration during which the cancer does not worsen, while duration of response indicates how long the treatment effect lasts. The rates of adverse events and serious adverse events were similar to those of the original drug, and no neutralizing antibodies that could diminish efficacy were detected.
Keytruda works by binding to the PD-1 immune checkpoint receptor, preventing cancer cells from evading the immune system and helping immune cells attack cancer cells. Last year, its global sales reached approximately $31.7 billion. Samsung Bioepis applied for product approval for SB27 with the Ministry of Food and Drug Safety in August, and submitted a request for approval in the United States last month.
Shin Dong-hoon, Vice President and Head of Clinical Development at Samsung Bioepis, stated, "By demonstrating the primary endpoint in this large-scale global Phase 3 trial, we have confirmed the clinical equivalence and consistent safety of SB27 compared to the original. We will focus our development efforts to enhance patient access to high-quality cancer biosimilars."
On November 9, Samsung Bioepis announced that its Keytruda biosimilar candidate, SB27 (active ingredient: pembrolizumab), demonstrated clinical equivalence to the original drug in a global Phase 3 trial. The findings were presented at the annual meeting of the American Society for Immunotherapy of Cancer (SITC 2026), held from November 4 to 8 in Phoenix, Arizona.
The trial, which began in 2024, involved 555 patients with metastatic non-small cell lung cancer across 14 countries. Participants received either SB27 or Keytruda alongside standard chemotherapy.
The primary endpoint, the objective response rate (ORR) at 24 weeks, met the equivalence criteria set by regulatory agencies. Secondary endpoints, including progression-free survival (PFS) and duration of response and overall survival (OS), were also comparable to the original drug.
Progression-free survival refers to the duration during which the cancer does not worsen, while duration of response indicates how long the treatment effect lasts. The rates of adverse events and serious adverse events were similar to those of the original drug, and no neutralizing antibodies that could diminish efficacy were detected.
Keytruda works by binding to the PD-1 immune checkpoint receptor, preventing cancer cells from evading the immune system and helping immune cells attack cancer cells. Last year, its global sales reached approximately $31.7 billion. Samsung Bioepis applied for product approval for SB27 with the Ministry of Food and Drug Safety in August, and submitted a request for approval in the United States last month.
Shin Dong-hoon, Vice President and Head of Clinical Development at Samsung Bioepis, stated, "By demonstrating the primary endpoint in this large-scale global Phase 3 trial, we have confirmed the clinical equivalence and consistent safety of SB27 compared to the original. We will focus our development efforts to enhance patient access to high-quality cancer biosimilars."
* This article has been translated by AI.
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