Pembrolizumab Monotherapy in Sorafenib-Treated and Treatment-Naive Advanced Hepatocellular Carcinoma: Long-Term Follow-Up of Open-Label, Phase 2 KEYNOTE-224 Study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
155 participants received ≥1 dose of pembrolizumab (cohort 1, n = 104; cohort 2, n = 51).
I · Intervention 중재 / 시술
pembrolizumab 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity for ≤35 cycles
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
추출되지 않음
[PURPOSE] In the phase 2 KEYNOTE-224 study, pembrolizumab showed durable antitumor activity and manageable safety in participants with sorafenib-treated (cohort 1) or treatment-naive (cohort 2) advanc
- 표본수 (n) 104
- 95% CI 9.7-15.3
- 추적기간 7 years
APA
Finn RS, Kudo M, et al. (2026). Pembrolizumab Monotherapy in Sorafenib-Treated and Treatment-Naive Advanced Hepatocellular Carcinoma: Long-Term Follow-Up of Open-Label, Phase 2 KEYNOTE-224 Study.. Clinical cancer research : an official journal of the American Association for Cancer Research. https://doi.org/10.1158/1078-0432.CCR-25-3528
MLA
Finn RS, et al.. "Pembrolizumab Monotherapy in Sorafenib-Treated and Treatment-Naive Advanced Hepatocellular Carcinoma: Long-Term Follow-Up of Open-Label, Phase 2 KEYNOTE-224 Study.." Clinical cancer research : an official journal of the American Association for Cancer Research, 2026.
PMID
41770235 ↗
Abstract 한글 요약
[PURPOSE] In the phase 2 KEYNOTE-224 study, pembrolizumab showed durable antitumor activity and manageable safety in participants with sorafenib-treated (cohort 1) or treatment-naive (cohort 2) advanced hepatocellular carcinoma (HCC). We present data after a median follow-up of ~7 years for cohort 1 and ~5 years for cohort 2.
[PARTICIPANTS AND METHODS] Adults with advanced HCC received pembrolizumab 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity for ≤35 cycles. Primary end point was objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR). Secondary end points included overall survival (OS), progression-free survival (PFS), and safety.
[RESULTS] Overall, 155 participants received ≥1 dose of pembrolizumab (cohort 1, n = 104; cohort 2, n = 51). Median follow-up was 83.0 months (range, 79.3-87.3) for cohort 1 and 58.8 (range, 55.3-60.8) for cohort 2. Median OS was 13.2 months (95% CI, 9.7-15.3) and 16.9 (95% CI, 8.3-23.1), respectively; 24/48-month OS rates were 31%/17% and 34%/20%. Median PFS was 4.9 months (95% CI, 3.5-7.0) and 4.3 (95% CI, 2.1-7.8), respectively. Treatment-related adverse events occurred in 76 participants (73.1%; grade 3-5, 27 [26.0%]) in cohort 1 and 28 participants (54.9%; grade 3-5, 8 [15.7%]) in cohort 2.
[CONCLUSION] Pembrolizumab continued to show durable response and manageable safety in participants with advanced HCC with or without prior systemic therapy, with long-term effects on OS lasting beyond 48 months in some participants despite receiving study treatment for ≤2 years.
[PARTICIPANTS AND METHODS] Adults with advanced HCC received pembrolizumab 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity for ≤35 cycles. Primary end point was objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR). Secondary end points included overall survival (OS), progression-free survival (PFS), and safety.
[RESULTS] Overall, 155 participants received ≥1 dose of pembrolizumab (cohort 1, n = 104; cohort 2, n = 51). Median follow-up was 83.0 months (range, 79.3-87.3) for cohort 1 and 58.8 (range, 55.3-60.8) for cohort 2. Median OS was 13.2 months (95% CI, 9.7-15.3) and 16.9 (95% CI, 8.3-23.1), respectively; 24/48-month OS rates were 31%/17% and 34%/20%. Median PFS was 4.9 months (95% CI, 3.5-7.0) and 4.3 (95% CI, 2.1-7.8), respectively. Treatment-related adverse events occurred in 76 participants (73.1%; grade 3-5, 27 [26.0%]) in cohort 1 and 28 participants (54.9%; grade 3-5, 8 [15.7%]) in cohort 2.
[CONCLUSION] Pembrolizumab continued to show durable response and manageable safety in participants with advanced HCC with or without prior systemic therapy, with long-term effects on OS lasting beyond 48 months in some participants despite receiving study treatment for ≤2 years.