JINAN,
China, Dec. 4, 2022 /PRNewswire/ -- Qilu
Pharmaceutical, one of the leading vertically integrated
pharmaceutical companies in China
that develops, manufactures, and distributes both finished
formulations and Active Pharmaceutical Ingredients, announced that
the results of the phase II study evaluating QL1604 plus
chemotherapy as first-line treatment for patients with recurrent or
metastatic (R/M) cervical cancer were released on 4 December 2022 in oral presentation (Proffered
Paper, 179O) at the European Society for Medical Oncology (ESMO)
Asia Congress 2022.
Cervical cancer is the fourth most frequently diagnosed cancer
and the fourth leading cause of cancer death in women worldwide.
Patients with R/M cervical cancer have a poor prognosis and the
5-year survival rate is less than 20%. Although immune checkpoint
inhibitors (ICIs) have shown clinical activity in R/M cervical
cancer as second-line treatment, the studies on ICIs given in the
first-line setting are limited.
QL1604 is a highly selective, humanized monoclonal antibody that
binds to PD-1. This is a phase II, open-label, single-arm study of
QL1604 plus chemotherapy in patients with R/M cervical cancer
(NCT04864782). Eligible patients received QL1604 200 mg plus
chemotherapy (paclitaxel and cisplatin/carboplatin) once every 3
weeks (Q3W) for up to 6 cycles, and then QL1604 200 mg Q3W for
maintenance therapy until disease progression or other
discontinuation events.
As of the data cutoff, 46 patients with R/M cervical cancer and
naïve to systemic treatment were enrolled at 12 sites in
China. Twenty (43.5%) patients
previously underwent surgery and 40 (87%) patients previously
received radiotherapy. Thirty-nine (84.8%) patients had recurrent
disease and 7 (15.2%) patients had stage IV disease.
The median follow-up time was 12.91 months. A total of 8 (17.4%)
patients achieved complete response and 19 (41.3%) patients
achieved partial response, resulting in 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). The overall survival was not reached.
QL1604 plus chemotherapy demonstrated a manageable safety
profile, which was consistent with that reported for chemotherapy
or anti-PD-1 therapy. The most common treatment-related adverse
event was white blood cell count decreased.
Ms. Xiaoyan Kang, Head of Qilu
Pharmaceutical clinical research center, stated, "We are pleased to
release the latest study results of QL1604 plus chemotherapy as
first-line treatment for patients with advanced cervical cancer.
QL1604 plus chemotherapy showed promising antitumor activity and
manageable safety profile as first-line treatment for women with
R/M cervical cancer. Further investigations in this setting are
ongoing."
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SOURCE Qilu Pharmaceutical Co., Ltd.