Qilu Pharmaceuticals Unveils Breakthrough Clinical Results for Innovative Bifunctional Antibody QL1706

Qilu Pharmaceutical is making waves in the medical industry with its innovative bifunctional antibody, QL1706, by presenting the latest progress of its clinical studies at several renowned international and Chinese academic conferences, such as the American Association for Cancer Research (AACR) 2022 Annual Meeting, the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, the Chinese Society of Clinical Oncology (CSCO) 2022 Annual Meeting, and the European Society for Medical Oncology (ESMO) 2022 Asia Congress. This antibody is proving to be a major breakthrough in cancer treatment and is sure to revolutionize the medical field.

QL1706 is an innovative combination of anti-PD-1 and anti-CTLA-4 monoclonal antibodies, developed on the MabPair technology platform. This bifunctional antibody utilizes mutations to reduce the elimination half-life of CTLA-4, resulting in shorter patient exposure to CTLA-4 antibodies and a proportional allocation between CTLA-4 IgG1 and PD-1 IgG4 antibodies. QL1706 provides a unique advantage for the treatment of advanced tumors, combining the activity of both PD-1 and CTLA-4 antibodies while helping to attenuate the toxicity caused by CTLA-4 antibodies. Clinical studies have shown that QL1706 has the potential to maximize the benefits of dual ICI therapy while minimizing the risk of adverse reactions.

At AACR’s annual meetings in 2021 and 2022, Qilu Pharmaceutical reported the results of the Phase Ia/Ib studies of QL1706 for advanced solid tumors in a poster presentation. After assessing the data, a dose of 5.0 mg/kg was established as the recommended dose (RP2D) in phase 2, and a total of 518 patients enrolled in the studies. 72.2% of these patients experienced treatment-related adverse events (TRAEs), with the most common being rashes (17.6%), pruritus (12.5%), and hypothyroidism (11.6%). 13.5% of patients experienced grade-3 TRAEs or higher, with two cases of dose-limiting toxicity (DLT) occurring in the QL1706 10 mg/kg dose group. This included one case of grade-3 thrombocytopenia with grade-1 gingival bleeding and one case of grade-4 immunomodulatory nephritis.

At the 2022 ASCO Meeting, Qilu Pharmaceuticals presented the results of the Phase Ia/Ib study of QL1706 for the treatment of advanced nasopharyngeal and cervical cancer, revealing promising efficacy. Of the 110 patients studied, 71.8% had received second-line therapies or above, and 43.6% had received immunotherapy. An impressive 24.5% of patients achieved objective response, with a confirmed ORR of 39.1% (9/23) and 38.5% (15/39) among those who had received first- and second-line therapies without immunotherapy, respectively. After a median follow-up of 7.7 months, the median progression-free survival (PFS) was 2.0 months and the 6-month PFS rate was an encouraging 47.4%. Though median overall survival (OS) data is yet to be determined, the results of this study offer hope for a potential treatment option for patients with advanced nasopharyngeal and cervical cancer.

QL1706 treatment showed promising results in a phase Ib study of 53 patients with cervical cancer. Among those enrolled, 83% had squamous carcinoma and 17% adenocarcinoma; and 62% and 38% had received first- and second-line (or above) treatment, respectively. After a median follow-up of 5.6 months, an impressive 34.0% of patients were still receiving treatment, with an overall response rate of 28% and a disease control rate of 55%. Furthermore, one lucky patient achieved complete response, while 14 experienced partial response. The median progression-free survival was 4.2 months, while the 6-month progression-free survival rate was a promising 37%. Although median overall survival was not reached, these results demonstrate the potential of QL1706 as a treatment for cervical cancer.

At the CSCO 2022 meeting, Qilu Pharmaceutical presented the results of their phase II clinical study of QL1706 in the first-line treatment of recurrent or metastatic cervical cancer. Among the 57 patients enrolled, 30 received QL1706 in combination with chemotherapy and QL1706 in combination with chemotherapy plus bevacizumab. The results were impressive, with an overall ORR of 77.2% and DCR of 98.2%. The ORR and DCR of the group treated with QL1706 in combination with chemotherapy were 74.1% and 100.0%, respectively; and QL1706 in combination with chemotherapy plus bevacizumab 80.0% and 96.7%, respectively. Although median PFS and median OS were not achieved at the data cut-off date, this success has led to a phase III clinical study (NCT05446883) to further evaluate the efficacy and safety of QL1706 in this setting.

At the recent ESMO Asia Congress, Qilu Pharmaceutical unveiled the results of their Phase II clinical study of QL1706 in combination with chemotherapy with or without bevacizumab for the treatment of advanced EGFR wild-type and EGFR mutant non-small cell lung cancer. Through two poster presentations (abstract numbers: 622 and 637), the company showcased their promising treatments, offering hope to patients in need.

QL1706, a promising immunotherapy drug, is paving the way for a new landscape of treatment options for a number of major diseases. Clinical studies are underway to investigate its efficacy in treating lung cancer, gastrointestinal tumors, gynecological tumors, head and neck tumors, and urological tumors. In addition, further Phase III clinical studies are being conducted to explore its potential use as a first-line and adjuvant therapy for non-small cell lung cancer and liver cancer. This is an exciting development for patients, as it may provide more options for addressing unmet clinical needs.

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