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Tianqing Chu
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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): Tianqing Chu
- 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.
cffcb1a185b2d7d5c44e9dc785b6bb25
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Mini Oral session II (ID 63)
- Event: ELCC 2019
- Type: Mini Oral session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 16:40 - 17:40, Room C
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117O - Racial disparities in characteristics and prognosis in Asian versus white patients receiving atezolizumab: An ancillary analysis of POPLAR and OAK studies (ID 339)
16:40 - 17:40 | Author(s): Tianqing Chu
- Abstract
- Presentation
Background
Racial differences in characteristics and prognosis of Asiatic and White patients receiving immunotherapy have not been well described.
a9ded1e5ce5d75814730bb4caaf49419 Methods
We studied 390 patients from the POPLAR and OAK studies who received atezolizumab with evaluable biomarker parameters retrieved from a subsequent blood-based study. The differences of Asians versus Whites in baseline characteristics, outcomes and genetic mutations of atezolizumab therapy were assessed.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Asiatic and White patients differed in characteristics including smoking history, baseline sum of the longest diameters (BLSLD), EGFR mutation frequency, programmed death-ligand 1 (PD-L1) expression and blood-based tumor mutational burden (bTMB) level. Overall survival (OS) was longer in Asians compared with Whites before (median OS: 18.7 vs. 11.1 mo; P = 0.005) and after (median OS: 20.9 vs. 12.6 mo; P = 0.005) propensity score matching (PSM). Race was an independent prognostic factor for OS (Asian vs White: HR 0.647, 95% CI 0.447-0.936, P = 0.021) in addition to performance status (PS), histology, BLSLD, and number of metastatic sites. The objective response rate (ORR) for Asians and Whites was 8.2% and 17.1%, respectively and disease control rate (DCR) was 51.2% and 47.7%, respectively. The blood-based mutational landscape differentiated between Asians and Whites. In the overall population, mutations of STK11, EGFR, KEAP1, POLE, GRM3, ATM and STAG2 were associated with treatment response while mutations of TP53, KEAP1, APC, RB1, CREBBP, EPHA5 and STAG2 were associated with OS. Comparing the frequency of efficacy- or prognosis- related mutations, Asians had more EGFR mutations and less TP53 and STK11 mutations than Whites.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Asians and Whites differed in the clinicopathological features and mutational landscape which may explain the superior efficacy of atezolizumab in Asiatic patients with NSCLC. This study conveys implications for further studies on racial disparity in the treatment of immunotherapy.
b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study
The authors.
213f68309caaa4ccc14d5f99789640ad Funding
Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Support (No. 20161434).
682889d0a1d3b50267a69346a750433d Disclosure
All authors have declared no conflicts of interest.
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