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Sang Won Shin
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MA26 - New Therapies and Emerging Data in ALK, EGFR and ROS1 (ID 930)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 201 BD
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MA26.09 - Lazertinib, a Third Generation EGFR-TKI, in Patients with EGFR-TKI-Resistant NSCLC: Updated Results of a Phase I/II Study (ID 12817)
14:30 - 14:35 | Author(s): Sang Won Shin
- Abstract
- Presentation
Background
Lazertinib (YH25448) is a highly mutant-selective, irreversible 3rd-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that can penetrate the blood-brain barrier, and targets the activating EGFR mutations Del19 and L858R, as well as the T790M mutation, while sparing wild type. We report the updated results from a Phase I/II study of lazertinib (NCT03046992)
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with advanced and metastatic NSCLC who had progressed after treatment with EGFR-TKIs with/without asymptomatic brain metastases (BM) were enrolled in an open-label, multicenter, phase I/II study with dose-escalation and expansion cohorts. Lazertinib was administered once daily at doses between 20 to 320 mg in a 21-day cycle. Patients were assessed for safety, tolerability, pharmacokinetics and efficacy. T790M status was confirmed in the dose-expansion cohorts.
4c3880bb027f159e801041b1021e88e8 Result
A total of 115 patients (median age 62 years, female 62%) were enrolled. The dose-escalation cohort included 38 patients administered with 20 to 320 mg across 7 dose levels, and 77 patients in the dose-expansion cohort were administered with 40 to 240 mg across 5 dose levels. No dose-limiting toxicities were observed in the dose-escalation cohort. Systemic exposure increased dose-dependently. Of the evaluable patients (n=110) at data cut-off, the objective response rate (ORR) was 65% (95% confidence interval [CI], 54.9 to 73.4). The ORR for 93 of the T790M+ patients was 69% (95% CI, 58.4 to 78.0). In patients with BM (n=12), the intracranial ORR was 50% (95% CI, 21.1 to 78.9). The most common treatment-emergent adverse events (TEAEs) were pruritus (19%), decreased appetite (17%), rash (14%), and constipation (12%). The most frequently reported TEAEs of grade ≥ 3 were hyponatraemia (2%), nausea (2%) and pneumonia (2%).
ORR in T790M+ patients Dose QD 20 mg 40 mg 80 mg 120 mg 160 mg 240 mg Evaluable patients*, n 2 25 18 22 18 8 ORR, n (%) 2 (100) 17 (68) 11 (61) 17 (77) 11 (61) 6 (75) * Patients were deemed evaluable for response if they underwent a post-baseline radiological assessment (RECIST 1.1) or were discontinued prior to the post-baseline assessment.
8eea62084ca7e541d918e823422bd82e Conclusion
Lazertinib was safe, well-tolerated and exhibited promising systemic and intracranial antitumor activity in EGFR T790M+ NSCLC patients. The dose-expansion cohort as the first and second-line setting has been initiated from April 2018.
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P3.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 983)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.17-04 - Dealing with the N2 Disesase in Non- Small Cell Lung Cancer- on the Edge. (ID 13071)
12:00 - 13:30 | Author(s): Sang Won Shin
- Abstract
Background
The current guidelines for the evaluation of mediastinal lymph nodes in the setting of lung cancer include EBUS with fine-needle aspiration and cytological evaluation to be enlarged on computed tomography (CT; short axis ≥1 cm). Optimal management of clinical stage IIIA (N2) NSCLC is controversial. This study is a systematic review and meta-analysis of published randomized control trials of multimodality management strategies for NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
We conducted a comprehensive literature search of the Pubmed databases for relevant studies comparing patients with stage IIIA (N2) NSCLC undergoing surgery alone, chemotherapy and/or radiotherapy alone, or surgical resection after neoadjuvant treatment with chemotherapy and/or radiotherapy. We estimated hazard ratios, odds ratios (ORs), and 95% confidence intervals (CIs) for survival data.
4c3880bb027f159e801041b1021e88e8 Result
Author treat No Median OS 3 ys surv p Median DFS p Albain et al S 202 23.6 37.9 0.24 12.8 0.017 CRT 194 22.2 33.9 10.5 Van Meerbeek et al S 167 16.4 24.9 0.596 17.2 0.605 CRT 165 17.5 27.8 15.8 Katakami et al CRT 29 39.6 51.7 >0.05 12.4 0.187 Cht 29 29.9 39.3 9.7 Girad et al CRT 32 - 51.8 - 17.2 - Cht 14 24.2 25.4 12.5 There was no significant difference in overall survival (OS) or progression-free survival (PFS) in stage IIIA (N2) NSCLC patients who received neoadjuvant chemotherapy or chemoradiotherapy prior to surgical resection compared to those who received neoadjuvant chemotherapy or chemoradiotherapy prior to radical radiotherapy. There was a significant increase in pathological complete remission in the mediastinal lymph nodes in stage IIIA (N2) NSCLC patients who received neoadjuvant chemoradiotherapy prior to surgical resection compared to those who received neoadjuvant chemotherapy.
8eea62084ca7e541d918e823422bd82e Conclusion
In general, North American surgeons are more likely to surgically stage the mediastinum before operation,
6f8b794f3246b0c1e1780bb4d4d5dc53
are less likely to offer surgical treatment when N2 disease is identified preoperatively and are more likely to use induction therapy
before resection. In contrast, European surgeons may offer operation as the initial treatment followed by adjuvant therapy in
selected cases of N2 disease, and they may perform a more aggressive intraoperative nodal dissection. Neoadjuvant chemotherapy and/or radiotherapy prior to surgical resection do not appear to be clinically superior to neoadjuvant chemotherapy and/or radiotherapy prior to definitive radiotherapy in IIIA (N2) NSCLC patients
