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Futoshi Kurimoto
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-39 - Clinical Characteristics of Long-Term Survivors with Nivolumab in Previously Treated Advanced NSCLC from Real World Data (Now Available) (ID 518)
10:15 - 18:15 | Author(s): Futoshi Kurimoto
- Abstract
Background
Nivolumab, a programmed death-1 immune checkpoint inhibitor antibody, has become one of the new standard therapies for previously treated advanced non-small cell lung cancer (NSCLC). However, there is limited information about the long-term survival of real-world patients treated with nivolumab in Japan.
Method
We performed a retrospective study of previously treated patients with advanced NSCLC who received nivolumab at 3 mg/kg every 2 weeks outside clinical trials from our institution in Saitama (Japan) between January 2016 and February 2017. We used real-world data (RWD) to analyze the clinical characteristics of patients who were alive 2 years after initiating nivolumab treatment.
Result
A total of 129 patients fulfilled the inclusion criteria. Thirty-eight patients (30%) were alive 2 years after receiving the first dose of nivolumab. The median age at initial nivolumab treatment was 65 years (38–79). Twenty-nine (76%) patients were male, 12 (32%) were never-smokers, 37 (97%) had performance status (PS) 0 and 1, and 30 (79%) had adenocarcinoma histology. Twenty-five (66%) patients received nivolumab as second-line therapy, and 9 (24%) had genetic abnormalities including 7 with epidermal growth factor receptor (EGFR) mutations. Thirty-four cases of programmed death-ligand 1 expression in tumor samples were not quantifiable. The best responses to nivolumab per the Response Evaluation Criteria in Solid Tumors version 1.1 included 12 partial responses (32%) and 6 complete responses (16%). Eleven 2-year survivors (29%) received nivolumab for more than two years, three (8%) discontinued nivolumab because of immune-related adverse effects, and four (11%) were retreated. Fourteen 2-year survivors (37%) received only nivolumab without subsequent therapy and did not display evidence of progressive disease at the last follow-up. These survivors exhibited significantly good PS, were male, had a history of smoking, and did not harbour somatic genetic abnormalities. Multivariate analysis identified only good PS as an independent positive predictor of survival of two years or more.
Conclusion
In our RWD experience, nivolumab resulted in a 2-year survival rate of 30% in previously treated patients with advanced NSCLC. The 2-year survival rate in a real-world clinical setting was slightly lower than that in a Japanese phase II study (ONO4538-05/06 study). Clinical characteristics associated with a positive treatment response were comparable to those observed in previous studies.
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.14-52 - The Results from Plasma EGFR Mutation Analysis in NEJ026 Study (ID 602)
10:15 - 18:15 | Author(s): Futoshi Kurimoto
- Abstract
Background
EGFR mutation analysis of plasma circulating tumor DNA (ctDNA) has been reported to be useful to detect resistant mutations and to predict the efficacy of treatment. In NEJ026 study, we demonstrated the PFS of erlotinib plus bevacizumab (BE) treatment was significantly superior to the erlotinib alone (E) in NSCLC patients harboring EGFR mutation. Evaluation of plasma EGFR mutations included in NEJ026 study as preplanned analysis.
Method
At the time points of pretreated (P0), 6 weeks after study treatment started (P1), and confirmed progressive disease (P2), the plasma samples were collected from the patients enrolled to NEJ026 study. The number of enrolled patients were 112 in BE and 114 in E. Plasma ctDNA analysis for detection of the activating EGFR mutation and T790M mutation were performed by modified PNA-LNA PCR clamp method.
Result
The total numbers of collected plasma samples in BE and E were 108 (96.4%) and 107 (95.5%) at P0, 95 (84.8%) and 97 (86.6%) at P1, and 42 (37.5%) and 53 (47.3%) at P2, respectively. In eligible patients having EGFR activating mutation detected by cytohistological specimens, detection rate of plasma EGFR mutation at P0 was 68% (147/215). The detection ratio of T790M mutation at P2 were similar in both arms: 8 (19.0%) in BE and 11 (20.8%) in E. By detection pattern of activating EGFR mutation, PFS was evaluated among three groups: type A (P0 (-),P1 (-)), type B (P0 (+), P1(-)), and type C (P0 (+), P1(+)). Type A achieved the best response to both TKI [Type A BE: 18.1 M (n = 32, 95% CI, 11.5 to upper limit not reached(NR)), E: 16.7 M (n = 26, 95% CI, 11.2 to NR )]. Type B also had better PFS to TKI and BE is more favorable effect than E compared to other types [type B BE: 15.5 M (n = 48, 95% CI, 12.4 to 23.3), E: 11.1 M (n = 57, 95% CI, 8.5 to 13.7)]. Type C showed worse response to both treatment [type C BE: 6.0M. (n = 12, 95% CI 2.6 to NR), E: 4.3 M (n = 10, 95% CI, 2.8 to 20.2)]. BE had better PFS in all types.
Conclusion
Frequency of T790M in P2 was similar among BE and E. When patients still had detectable activating EGFR mutation in plasma ctDNA after treatment for 6 weeks, you should consider that they might have poor response to both BE and E.
