In first-line treatment for HER2-positive gastric cancer, the combination of Keytruda (pembrolizumab), Herceptin (trastuzumab), and chemotherapy reduced the risk of death by 20% compared to the current standard of Herceptin and chemotherapy. This may signal a new standard treatment.
On September 14th, final overall survival (OS) data from the KEYNOTE-811 study, presented at the ESMO Annual Meeting, showed that Keytruda met both primary efficacy endpoints, including progression-free survival (PFS), for patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
At a median follow-up of 50.2 months, the Keytruda combination group had a median overall survival of 20.0 months (95% CI: 17.8-22.1), compared to 16.8 months (95% CI: 14.9-18.7) in the Herceptin plus chemotherapy group, indicating a 20% reduction in the risk of death (HR=0.80, 95% CI: 0.78-0.94, p=0.0050).
For patients with PD-L1 expression (CPS ≥1), who made up 85% of the participants, the Keytruda combination showed an even greater benefit. In this group, median OS was 20.1 months (95% CI: 17.9-22.9), reducing the risk of death by 21% compared to 15.7 months (95% CI: 13.5-18.5) in the control group (HR=0.79, 95% CI: 0.66-0.95). Progression-free survival (PFS) was also improved, with 10.0 months (95% CI: 8.5-12.6) for the Keytruda group versus 7.3 months (95% CI: 6.8-8.4) in the control, reflecting a 28% reduction in the risk of disease progression or death (HR=0.72, 95% CI: 0.60-0.87).
Dr. Sara Lonardi from the Veneto Institute of Oncology, Italy, who presented the findings, stated, “These data clinically and statistically demonstrate that the combination of Keytruda, Herceptin, and chemotherapy improves overall survival in patients with PD-L1-positive/HER2-positive unresectable or metastatic gastric cancer. This confirms that Keytruda combination therapy represents a new treatment approach, poised to replace the current standard of care.”
Despite these promising results, the Keytruda combination therapy is not yet covered by insurance for HER2-positive gastric cancer in South Korea. There is growing interest in whether this data might lead to progress in securing reimbursement.
출처 : 히트뉴스(http://www.hitnews.co.kr)
