On December 4, 2022 Qilu Pharmaceutical, one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished formulations and Active Pharmaceutical Ingredients, reported 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) (Free ESMO Whitepaper) Asia Congress 2022 (Press release, Qilu Pharmaceutical, DEC 4, 2022, View Source [SID1234624756]).

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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.