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Article source: Medical Rubik's Cube Info
On September 21st, Wanchun Medicine issued an oral report at the ESMO2021 conference on the international multi-center of the second/third-line treatment of pranabulin combined with docetaxel versus docetaxel for the second/third-line treatment of EGFR wild-type non-small cell lung cancer patients Detailed results of the Phase III study (DUBLIN-3)
.
The DUBLIN-3 study is an international multi-center phase III, randomized, controlled clinical study conducted in second/third-line NSCLC patients with disease progression after first-line platinum-containing chemotherapy and wild-type epidermal growth factor receptor (EGFR).
The safety and effectiveness of the combination treatment group of ponabrine and docetaxel and the single-agent treatment group of docetaxel (1:1 randomized)
.
Subjects in both groups received 75 mg/㎡ docetaxel on the first day of each chemotherapy cycle (21 days), and the combined treatment group received docetaxel 1 hour and 8 days after the first day.
The main selection criteria for DUBLIN-3 include patients with measurable lung lesions (RECIST 1.
1 criteria)
.
At the time of randomization, the patients were stratified according to whether they received PD-1/PD-L1 antibody therapy in the past
Professor Han Baohui from Shanghai Chest Hospital entrusted Professor Trevor Feinstein to report an international multi-center, phase III, randomized controlled clinical study in the form of an on-site oral presentation at the annual meeting of the ESMO Society.
Professor Shi Yuankai from Cancer Hospital and Professor Han Baohui from Shanghai Chest Hospital took the lead to evaluate the safety and effectiveness of pranabulin combined with docetaxel versus single-agent docetaxel in the second/third-line treatment of EGFR wild-type NSCLC
.
A total of 559 subjects were enrolled globally, and they were randomly assigned to the Pranabrin combined with docetaxel group (n=278) or the placebo combined with docetaxel group (n=281) to receive Pranabrin (30 mg/㎡, 1 hour after docetaxel administration on day 1 and 8 days) or placebo combined with docetaxel regimen (Q3W)
.
The primary endpoint of OS, secondary endpoints include: ORR, PFS, the incidence of grade 4 neutropenia disease, 24 months rate OS, OS rate of 36 months, 48 months OS rate
Compared with chemotherapy alone, pranabulin combined with chemotherapy significantly prolonged the survival of patients.
The average OS was 15.
08 months vs 12.
77 months, the median OS was 10.
5 months vs 9.
4 months, and the 24-month OS rate (22.
1 % vs 12.
5%), 36-month OS rate (11.
7% vs 5.
3%), and 48-month OS rate (10.
6% vs 0%) all increased significantly, showing that the combined regimen has long-lasting anti-cancer benefits
.
Subgroup analysis showed that the survival benefit of subjects was directly related to the number of cycles received pranabulin treatment, and the survival time of subjects receiving pranabulin treatment for ≥4 or ≥8 cycles was significantly prolonged
.
Compared with the chemotherapy alone group, the median OS of ≥4 cycles in the prinabulin treatment group was 18.
The average PFS of the prinabulin group and the placebo group was 6.
0 months vs.
4.
4 months, the median PFS was 3.
6 months vs.
3.
0 months, and the ORR was 12.
23% vs.
6.
76%
.
In terms of safety, the incidence of grade 4 neutropenia in the Pranabrin combined treatment group was significantly reduced (the 8th day of the first course of treatment: 27.
8% vs 5.
26%; the 8th day of the entire course of treatment: 33.
58% vs 5.
13% ), in the first week of the chemotherapy cycle, it has a protective effect on the prevention of severe neutropenia and is well tolerated
.
Compared with the control group, the quality of life of patients is better.
The results of the study show that the addition of pranablin to the standard second-line docetaxel chemotherapy regimen can enable patients with advanced or metastatic NSCLC to obtain better PFS and OS, significantly reduce the risk of disease progression or death in patients, and achieve long-lasting long-term survival , And significantly reduce the incidence of CIN and improve survival benefits
.
These results are expected to support prinabulin combined with chemotherapy as the new second-line standard treatment for advanced or metastatic ESCC
Lung cancer is currently the world's second most common malignant tumor with the second highest mortality rate [1]
.
According to data released by the World Health Organization, the number of lung cancer cases in China in 2020 accounted for 17.
After a number of PD-1/PD-L1 inhibitors have been approved in China, although the access rate of patients receiving immunotherapy has been greatly improved, the number of people who have stopped treatment due to non-response due to disease progression or immune adverse reactions has also greatly increased
.
The NCCN guidelines recommend that if the patient progresses during PD-1/PD-L1 inhibitor treatment, the use of another PD-1/PD-L1 inhibitor is not recommended later
Note: The original text has been deleted
references:
[1]https://gco.
iarc.
fr/today/data/factsheets/cancers/15-Lung-fact-sheet.
pdf
[2]https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf
[3]Rosell R, Karachaliou N.
Large-scalescreening for somatic mutations in lung cancer.
Lancet, 2016, 387(10026):1354-1356.
doi: 10.
1016/S0140-6736(15)01125-3
[4]Molina JR, et al.
Mayo Clin.
Proc.
2008; 83(5), 584–594.
