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Yukihiro Yano
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FP02 - Health Services Research/Health Economics (ID 120)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP02.04 - NSCLC with TPS>90% could have Higher Possibility of Causing Severe irAE; Retrospective Investigation in one Institution (ID 869)
00:00 - 00:00 | Author(s): Yukihiro Yano
- Abstract
Introduction
Recently, immune checkpoint inhibitors (ICI) have been introduced into clinical treatment strategy for advanced or recurrent NSCLC. However, little is known about the relation between the risk of irAE and patients’ clinical backgrounds. In this research, we attempted to reveal which types of clinical backgrounds are likely associated with the development of severe irAE when they were treated with ICI.
Methods
We have treated over 300 advanced or recurrent NSCLC with ICI in our institute since January 2016, and the results of TPS were obtained in 240 patients. We retrospectively analyzed the relationship between patients’ clinical backgrounds and severe irAE which caused discontinuation of treatment.
We excluded patients who were treated with durvalmab because it has different treatment strategy from other ICIs.
Results
Patients' background is shown below. We defined TPS>90% as ultra-high TPS, because those patients are shown to have preferable response to ICI. All the patients with EGFR mutation received EGFR-TKI before ICI.
first-line group second or later-line group 95 145 charasteristic Age, years median 71.9 70.2 range (95% C.I.) 70.2-73.6 68.9-71.6 Sex female 18 ( 18.9%) 56 ( 38.6%) male 77 ( 81.1%) 89 ( 61.4%) Histologic diagnosis adenocarcinoma 48 ( 50.5%) 89 ( 61.4%) squamouscarcinoma 38 ( 40.0%) 37 ( 25.5%) others 9 ( 9.5%) 19 ( 13.1%) ECOG performance status good (0 or 1) 80 ( 84.2%) 96 ( 76.8%) poor (2 -4) 15 ( 15.9%) 29 ( 23.2%) TPS high expression (>50%) 67 (70.5%) 40 (27.6%) low expression (1-49%) 22 (23.2%) 56 (38.6%) negative (<1%) 6 ( 6.3%) 49 (33.8%) ultra-high expression (>90%) 32 ( 33.7%) 19 ( 13.1%) Driver mutation no 92 ( 96.8%) 105 ( 72.4%) yes 3 ( 3.2%) 40 ( 27.6%) EGFR / KRAS / HER2 / others 0 / 2 / 1 / 0 36 / 1 / 2 / 1 ICI pembrolizumab 84 ( 88.4%) 57 ( 39.3%) nivolumab 0 ( 0%) 62 ( 42.8%) atezolizumab 11 ( 11.6%) 26 ( 17.9%) Forty-six had severe irAE of any grade of ILD or >Grade3 AE, and most of them were treated with steroids. Nineteen of them received ICI subsequently.
Univariate analysis indicated that TPS>50%, first-line treatment and administration of pembrolizumab showed significantly higher possibility of severe irAE (p<0.05, p<0.001, p<0.05, respectively). Furthermore, patients with ultra-high TPS was likely to experience severe irAE compared to other groups (p<0.01). When we examine the patients in first-line treatment, only ultra-high TPS showed statistically higher tendency of irAE (p<0.05). However, in second or later-line patients, no clinical backgrounds indicated the higher risk of irAE.
No difference was observed in response rate between ultra-high and other group in first-line treatment (71.9%, 61.9% respectively, p=1.0). In later-line, ultra-high group showed better response rate than others (52.6%, 19.8% respectively, p=0.032). However, no differences were observed in time to treatment failure and OS between ultra-high and others.
In 1st-line patients, TTF of ultra-high and others was 207days and 175days (p=0.306), OS was 727days and 742days, respectively (p=0.74). In later-line, TTF was 107days and 70days(p=0.109),and OS was 511days and 308days (p=0.448).
Conclusion
Patients with ultra-high TPS had higher possibility of irAE especially when they received ICI for first-line. However, no difference was observed in OS between two groups. In our investigation, survival was not translated from better response in ultra-high group.
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FP14 - Targeted Therapy - Clinically Focused (ID 252)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP14.16 - Phase 2 Trial of the Alternating Therapy with Osimertinib and Afatinib for Treatment-Naive Patients with EGFR-Mutated Advanced Non–Small Cell Lung Cancer (WJOG10818L/Alt Trial) (ID 3084)
00:00 - 00:00 | Author(s): Yukihiro Yano
- Abstract
- Presentation
Introduction
First-line therapy with an EGFR tyrosine kinase inhibitor (TKI) is standard of care for patients with EGFR-mutated NSCLC. Whereas osimertinib is sensitive to the acquired mutation T790M in 1st/2nd generation EGFR-TKI resistant patient, afatinib overcomes the resistance of osimertinib due to highly express HER2/HER3 or C797S mutations. Osimertinib and afatinib may deliver drug efficacy in a complement manner, therefore, we conducted the phase II clinical trial to evaluate the efficacy of alternative treatment strategy of osimertinib and afatinib.
Methods
Patients with treatment-naive stage IV EGFR-mutated (L858R or del19) NSCLC were enrolled. Orally osimertinib 80 mg once a day for 8 weeks, followed by afatinib 20 mg once a day for 8 weeks, which was repeated alternately. Primary endpoint was one-year PFS rate evaluated by investigators based on RECIST 1.1. A minimum of 36 evaluable patients were required for the lower limit of 60% confidence interval for 1 year PFS rate to be more than the threshold of 64% with power of 80%, where the expected was assumed to be 77%.
Results
From Nov 2018 to Feb 2019, 46 pts were enrolled and treated with study therapy. One-year PFS rate was 70.18% (60% CI: 63.9%-75.59%, 95% CI: 54.22%-81.48%), which didn’t meet primary endpoint. Thus, the actual 60% CI lower limit is 63.9% thus very close to the threshold. The ORR and one-year survival rate were 69.6% (95% CI: 54.2%-82.3%) and 93.48% (95% CI: 81.13%-97.85%), respectively. The most common treatment-related adverse effects (TRAEs) (% any grade, % grade 3) were diarrhea (73.9%, 4.3%), rash acneiform (63.0%, 2.2%) and paronychia (52.2%, 0%). Pneumonitis was observed in 5 patients, all of whom were being treated with osimertinib. Baseline heregulin level was not correlated with the efficacy. Plasma EGFR determined by digital PCR is under evaluation.
Conclusion
Although current study didn’t meet the primary endpoint of one-year PFS rate, alteration therapy with osimertinib and afatinib demonstrated promising efficacy and tolerability for first-line treatment of EGFR-mutated NSCLC. Clinical trial information: jRCTs051180009
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