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Qilu Pharmaceutical is one of the large-scale comprehensive modern pharmaceutical enterprises, integrating R&D, production and sales of finished preparations and APIs
.
On December 4, 2022, at the 2022 Asian Congress of the European Society of Oncology (ESMO), Qilu Pharmaceutical announced the results of the phase II clinical study
of QL1604 combined with chemotherapy in the first-line treatment of patients with relapsed or metastatic (R/M) cervical cancer in the form of an oral report (Proffered Paper, 179O).
Worldwide, cervical cancer has the fourth
highest incidence and mortality rate among women.
Patients with R/M cervical cancer have a poor prognosis, with a 5-year survival rate of less than 20%.
Although immune checkpoint inhibitors (ICIs) have shown clinical efficacy in patients with R/M cervical cancer in the second-line treatment, the results of their use in first-line therapy are limited
.
QL1604 is a highly selective humanized monoclonal antibody
bound to PD-1.
This report is a phase II, single-arm, open-label study (NCT04864782)
of QL1604 in combination with chemotherapy in patients with R/M cervical cancer.
Enrolled patients received QL1604 200 mg combination chemotherapy (paclitaxel and cisplatin/carboplatin) every 3 weeks (Q3W) for up to 6 cycles, followed by QL1604 200mg Q3W maintenance therapy until disease progression or other discontinuation events
.
At the end of the data, a total of 46 patients
with R/M cervical cancer were admitted to 12 research centers in China.
Among them, 20 (43.
5%) patients had previous surgery, and 40 (87%) patients had received previous radiotherapy
.
Thirty-nine (84.
8%) were relapsed patients and 7 (15.
2%) were stage IV patients
.
The median follow-up was 12.
91 months
.
Eight (17.
4%) patients achieved complete remission and 19 (41.
3%) patients achieved partial remission, with an objective response rate of 58.
7% (27/46).
The disease control rate was 84.
8% (39/46).
The median duration of response was 9.
6 months (95% CI: 5.
5, NE).
The median progression-free survival was 8.
1 months (95% CI: 5.
7, 14.
0).
Overall survival has not been reached
.
Fig.
1 Optimal change of target lesion from baseline
Fig.
2 Kaplan-Meier curve for progression-free survival
QL1604 in combination with chemotherapy has shown good safety profiles, and its safety profile is consistent with
the results reported by chemotherapy or anti-PD-1 therapy.
The most common treatment-related adverse event was a decreased
white blood cell count.
Ms.
Kang Xiaoyan, Head of Clinical Research Center of Qilu Pharmaceutical, said: "We are pleased to announce the latest results of the results of QL1604 combined with chemotherapy first-line treatment of patients with advanced cervical cancer, QL1604 combined with chemotherapy first-line treatment of R/M cervical cancer women shows positive anti-tumor activity and controllable safety
.
Further research in this direction is
ongoing.
"
