Qilu Pharmaceutical Showcases QL1706 Clinical Trial Outcomes in Oral Presentation at ESGO 2024
15 Mar 2024
Clinical ResultPhase 2ImmunotherapyPhase 3ASCO
JINAN, China, March 15, 2024 /PRNewswire/ -- On 8 March local time, during the 25th European Society of Gynecological Oncology (ESGO) Conference (ESGO 2024) in Spain, Qilu Pharmaceutical unveiled the Phase II clinical trial results for iparomlimab and tuvonralimab (QL1706) in an oral presentation. This trial, known as DUBHE-C-206, recruited patients with recurrent or metastatic cervical cancer who failed first-line standard treatments. The findings were presented by Professor Jihong Liu from the Sun Yat-sen University Cancer CenterCancer Center in China.
Study Background and Design
Cervical cancer is one of the most prevalent malignancies among women and a leading cause of cancer-related death. For those who have failed the first-line standard therapy, the currently available treatment options are inadequate. The objective response rate (ORR) for pembrolizumab was 12.2%, with an ORR of 0% in the PD-L1-negative population[1]. Additionally, the median progression-free survival (PFS) and median overall survival (OS) were reported to be 2.1 months and 9.4 months, respectively. Similarly, cemiplimab showed an ORR of 16.4%, with a median PFS of 2.8 months and a median OS of 12.0 months[2]. This highlights the unmet need for effective and safe clinical treatments for patients with cervical cancer who failed first-line therapy. By targeting and inhibiting two immune checkpoint pathways (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), Qilu Pharmaceutical's proprietary drug QL1706 has shown a favorable safety profile and preliminary efficacy in patients with cervical cancer in early studies. The DUBHE-C-206 study aimed to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
This study was a multi-center, single-arm, open-label phase II clinical trial which enrolled patients with recurrent or metastatic cervical cancer who failed first-line platinum-based chemotherapy (with or without bevacizumab) and without prior immunotherapy. Participants received QL1706 at a dose of 5.0 mg/kg once every three weeks (Q3W). The primary endpoint of the trial was the ORR as assessed by an Independent Evaluation Committee (IRC). Secondary endpoints included the ORR as evaluated by investigators, duration of response (DoR) and disease control rate (DCR) as assessed by both IRC and investigators, PFS, 6-month and 12-month PFS rates, OS, 12-month OS rate, as well as safety, pharmacokinetics, and immunogenicity.
Study Results
As of April 28, 2023, the study had enrolled 148 patients with a median age of 53.0 years, including 132 (89.2%) diagnosed with squamous cell carcinoma. Of these participants, 109 (73.6%) had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 1. Additionally, 105 (70.9%) patients had a combined positive score (CPS) of ≥1, while 43 (29.1%) had a CPS of Hanmei Lou from Zhejiang Cancer HospitalCancer Hospital stated, "For ACC patients who have failed first-line therapy, the available treatment options are still limited and exhibit unsatisfactory efficacy, highlighting substantial unmet clinical needs. The efficacy and safety data from the DUBHE-C-206 study are promising. Compared with the previously reported combination therapy involving PD-1 and CTLA-4 inhibitorsCTLA-4 inhibitors, QL1706 has demonstrated reduced toxicity and offers notable advantages in both safety and efficacy. This further supports the use of dual immunotherapy for the treatment of recurrent or metastatic ACC. Consequently, the data from the DUBHE-C-206 study holds significant clinical value and implications."
Ms Xiaoyan Kang, Executive Deputy General Manager of Qilu Pharmaceutical's Clinical Research & Development Center and Chief Medical Officer (CMO) for Oncology, explained, "QL1706 represents the world's first dual-functional MabPair antibody targeting both PD-1 and CTLA-4 pathways. Data from several clinical studies of this novel drug have been released. The inclusion of the latest clinical trial results in the oral presentation at the ESGO conference underscores the international academic community's interest in and recognition of the clinical potential of this novel product. Currently, multiple Phase III clinical trials involving QL1706 are in progress, covering various disease indications. Going forward, we plan to further accelerate the clinical development of QL1706 to ensure that this treatment can reach and benefit patients as soon as possible."
References:
1. J Clin Oncol. 2019;37(17):1470-1478.
2. N Engl J Med. 2022;386(6):544-555.
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