ASCO GU 2021: Results of late or metastatic urethroid skin cancer in the Adiliju monotherapy bureau (IMvigor 130 study)

Atezolizumab (anti-PD-L1) monotherapy has been approved for use in patients who do not meet the requirements of cisplatin therapy, these patients in local or advanced metastatic urethroid cortoma PD-L1 expression of immune cells ≥ 5% of the tumor area (IC2 / 3 per VENTANA SP142 IHC analysis method). Preliminary analysis of IMvigor130 shows that, as a first-line treatment for the formation of endodermic urethrial cancer, Artiliju monoanti-anti-combination platinum/arm A is superior to placebo platinum/gisithamin .D.
, the interim overall survival figures for Groups A and C were encouraging, but premature.
same time, although the IMvigor130 study reached the end of the common primary study in PFS, the data were not stunning that the total lifetime of Atezolizumab single-drug therapy (Arm B) could not be formally evaluated, but good results were observed in IC2/3 patients.
at the 2021 American Society of Clinical Oncology's Urological System Cancer Symposium (ASCO GU), Dr. Matthew Galsky and colleagues presented the results of their exploratory analysis of IMvigor 130, which assessed outcomes in patients with cisplatin through PD-L1 status.
IMvigor130 study is a randomized controlled multi-center Phase III. clinical study of atezolizumab combined chemotherapy for local progression or first-line treatment of late-stage bladder urethroid cancer.
group of patients with local progressive or metastatic urethroid cancer that had not been systematically treated in the past, and these patients were able to withstand platinum drug chemotherapy, and 1,200 cases were scheduled to be treated at random in group 1:1:1, three of which were: Group A - Atili pearl monotherapy (Gisitalbin combined cisplatin or carp platinum); Atiliju monodratives; Group C - pure platinum chemotherapy (Gissythabhamin combined cisplatin or carbaptonin) and placebo, the main layering factors were PD-L1 expression (0, 1, 2/3), Bajorin risk score (0, 1, 2 or liver metastasis) and the researchers decided to choose platinum drugs (cisplatin, carabin).
the common main endpoint is the total lifetime (OS) and non-progressive lifetime (PFS) assessed by the researchers in the intentional population based on RECIST v1.1, and the secondary study endpoint is the objective efficiency and duration and safety of the efficacy assessed by the researchers.
the total lifetime (common primary endpoint) is assessed through the hierarchical endpoint: Group A and Group C are evaluated, followed by a comparison of group b and group C treated population and IC2/3 patients.
the overall survival rate and THECIST 1.1 objective mitigation rate (per researcher, secondary endpoint).
in the treatment of the population, there was no difference in the overall survival rate (HR 1.02, 95% CI 0.83-1.24) compared to placebo plus platinum/arm C.
, in patients with PD-L1 IC2 /3, comparing Arm B with Arm C did not have a survival advantage (HR 0.68, 95% CI 0.43-1.08), but overall Survival rate (Arm B vs Arm C: HR 0.53,95 (%CI 0.30-0.94) and objective response benefits (Arm B 38%, 95% CI 25-53; Arm C 33%, 95% CI 19-49) in IC2/ 3 patients who were treated with azolizumab that did not conform to cisplatin therapy: In the generally safe population, 60% of group B and 96% of group C patients had all adverse treatment-related reactions.
treatment-related adverse events occurred in 15% of Arm B and 81% of Arm C patients.
exploratory analysis of the IMvigor130 trial, the following points can be drawn: Many patients with metastatic urethroid skin cancer are not suitable for first-line chemotherapy based on cisplatin and require other treatment options IMvigor130 to show significant benefits, and Encouraging medium-term overall survival data were obtained in favour of atili-pearl monoanti-platinum/gisithamin and placebo combined platinum/gisithamin as a first-line treatment for metastatic urethra endoskine cancer (A-arm and C-arm) in this exploratory study The results showed that, compared with placebo plus platinum/gissythadin, atilijutin monodiotherapy improved the overall survival rate of patients with inappropriate cisplatin therapy and IC2/3 status, and the objective objectivity of atilijutin monoanti Higher remission rates Combined with better resistance to chemotherapy, these results provide another evidence that the use of atilijutin monotherapy to treat patients with IC2 / 3 metastatic urethroid cancer that is not applicable to first-line cisplatin