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On May 19th, Bristol-Myers Squibb released the new 6.
5-year data of the randomized double-blind phase 3 clinical trial CheckMate-067.
The results showed that: in the first-line treatment of advanced melanoma, compared with Opdivo monotherapy and Yervoy monotherapy, Opdivo+Yervoy combination therapy continued to improve survival, and nearly half of the patients were still alive after 6.
5 years of follow-up
.
In contrast, ten years ago, patients diagnosed with metastatic melanoma had an average life expectancy of only 6 months, and less than 10% of patients survived more than 5 years
The 6.
5-year follow-up results from the CheckMate-067 trial will be announced at the 2021 American Society of Clinical Oncology (ASCO) online annual meeting in early June
.
The specific data are as follows:
With a minimum follow-up of 6.
5 years, the median overall survival (OS) of patients in the Opdivo+Yervoy treatment group was 72.
1 months (95%CI: 38.
2-NR), which was the longest OS reported in a phase 3 clinical trial of advanced melanoma; The median OS in the Opdivo single-agent group was 36.
9 months (95% CI: 28.
2-58.
7), and the median OS in the Yervoy single-agent group was 19.
9 months (95% CI: 16.
8-24.
6)
.
In terms of disease progression-free survival, the 6.
5-year disease progression-free survival rate of patients in the Opdivo+Yervoy treatment group was 34% (median PFS of 11.
5 months), while the Opdivo monotherapy group was 29% (median PFS of 6.
9 months) 7% in Yervoy monotherapy group (median PFS is 2.
9 months)
.
Among the 49% of the follow-up patients who were still alive, 77% in the Opdivo+Yervoy treatment group (n=112/145), 69% in the Opdivo monotherapy group (n=84/122), and 43% in the Yervoy monotherapy group (27/63) patients have stopped treatment and have never received follow-up systemic treatment
.
In all relevant subgroups, including patients with BRAF mutations, wild-type tumors and liver metastases, Opdivo+Yervoy combination therapy and Opdivo monotherapy showed sustained clinical benefits: (1) Among patients with BRAF mutation tumors: 6.
5 years The survival rate was 57% in the Opdivo+Yervoy treatment group, 43% in the Opdivo single-agent group, and only 25% in the Yervoy single-agent group
.
(2) In BRAF wild-type tumor patients: 6.
In terms of median duration of remission (DoR), the Opdivo+Yervoy treatment group and Opdivo single-agent group have not yet reached, while the Yervoy single-agent group is 19.
2 months
.
The safety of the Opdivo+Yervoy combination is consistent with previous findings, no new safety signals have been observed, and no other treatment-related deaths have occurred since the 5-year analysis
.
59% of the Opdivo+Yervoy treatment group, 24% of the Opdivo single-agent group, and 28% of the Yervoy single-agent group reported grade 3/4 treatment-related adverse events
Reference source: Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Continue to Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma