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The 2022 European Society for Internal Oncology (ESMO) Annual Meeting was held
Chemotherapy in combination with anti-VEGF therapy or anti-EGFR targeted therapy has become the first-line standard of care for
Anlotinib is a novel oral multi-target TKI that inhibits tumor vascular production, and previous studies have suggested that alotinib can significantly prolong progression-free survival (PFS)
The ALTER-C001 trial is a single-arm, open-label, multicenter Phase II study designed as shown in
Figure 1 Study design
As of April 22, 2022, the study included a total of 31 patients with baseline characteristics as shown in
Table 1 Patient baseline features
As shown in Figure 2, the median PFS was 7.
79 months (95% CI: 6.
80-8.
78) and the median DOR was 5.
98 months (95% CI: 4.
32-7.
64).
Figure 2 PFS and DOR analysis of patients
The researchers evaluated efficacy in 24 patients, and as shown in Figure 3, the ORR of the patients was 62.
5% (95% CI: 40.
6-81.
2%) and the DCR was 91.
7% (95% CI: 73.
0-99.
0%)
.
Figure 3 Patient disease remission
As shown in Table 2, the safety analysis shows that the scheme is well
tolerated.
Treatment-related adverse events (TRAEs) are mostly grades 1 to 2, ≥ grade 3 TRAEs are mainly hypertension (16%), neutropenia (13%), and hypertriglyceridemia (10%)
.
Table 2 Security analysis
Conclusion of the study
The ALTER-C001 trial showed that alotinib plus XELOX regimen sequential anlotinib monotherapy showed good clinical benefit and controlled safety as a first-line treatment in patients with mCRC, and researchers believe that large randomized studies should be conducted to further evaluate this treatment strategy
.
References
1.
Yan Jin, et al.
Updated results from the multicenter phase II, ALTER-C001 trial: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC.
402P 2022 ESMO Congress.
Reviewer: Traveler
Typesetting: Youshi
Executive: Tourist
END
