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Tao Bai



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      172P - A multi-center, randomized, double-blind, parallel, two-group phase III clinical study on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in the first-line treatment of non-squamous non-small cell lung cancer (ID 437)

      12:30 - 13:00  |  Author(s): Tao Bai

      • Abstract

      Background

      QL1101 is a biosimilar molecule of bevacizumab (BEV,Avastin®) which is a monoclonal antibody (mAb) that binds and inhibits vascular endothelial growth factor (VEGF). The main purpose of the study is to evaluate whether the effectiveness of QL1101 is equivalent to that of Avastin®; the secondary purpose is to estimate the safety and immunogenicity.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The study planed the recruitment of 512 patients with locally metastatic or recurrent non-squamous cell non-small cell lung cancer (NCT03169335). into QL1101 (test group) or Avastin® (control group) in combination with paclitaxel/carboplatin (paclitaxel 175mg/m2, carboplatin AUC=5) at a 1:1 ratio. QL1101 and Avastin (15mg/kg respectively) combined with chemotherapy, were given every 3 weeks as one treatment cycle for 6 cycles, then followed by QL1101 single-drug maintenance treatment. The primary endpoint was the best objective response rate (ORR) at week 18 evaluated by the blind independent imaging review committee.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      A total of 675 subjects were screened and 532 were eventually treated, including 266 in the trial group and 266 in the control group. At week 18, the ORR of the QL1101 group and Avastin group, evaluated by the blind independent imaging review committee, were 52.26% (CR:0, PR:139) .and 56.02% (1 cases CR, 148 PR), respectively. Risk ratio (RR) value and 90%CI was 0.933(0.818-1.064), which met the prespecified equivalence margins (0.75-1.33).The median progression-free survival in the two groups was 7.72 and 8.25 months, respectively (HR: 1.111 (0.919—1.342)). The adverse reverse incidence of CTCAE ≥ 3 in the two groups were: 31.20 % in the experimental group and 24.06 % in the control group, respectively (P = 0.0808). The immunogenicity of the two groups was similar, and no neutralizing antibodies were detected.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      QL1101 and Avastin are equivalent in clinical efficacy in non-squamous cell non-small cell lung cancer patients, and the safety profile (including immunogenicity) is similar. There are no unexpected serious adverse reactions found.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT03169335; May 30, 2017.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Qilu Pharmaceutical Co., Ltd, Shandong, People’s Republic of China.

      213f68309caaa4ccc14d5f99789640ad Funding

      Qilu Pharmaceutical Co., Ltd, Shandong, People’s Republic of China.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

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