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Tae Min Kim
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OA04 - New Data from Rare EGFR Alterations (ID 223)
- Event: WCLC 2020
- Type: Oral
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 11:45 - 12:45, Scientific Program Auditorium
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OA04.03 - Mobocertinib in NSCLC With EGFR Exon 20 Insertions: Results From EXCLAIM and Pooled Platinum-Pretreated Patient Populations (ID 3186)
11:45 - 12:45 | Author(s): Tae Min Kim
- Abstract
- Presentation
Introduction
Mobocertinib is a potent first-in-class tyrosine kinase inhibitor (TKI) designed to target EGFR exon 20 insertion (EGFRex20ins) mutations. We report first results from the EXCLAIM extension cohort of a phase 1/2 study (NCT02716116) and results in patients with EGFRex20ins-mutant NSCLC who received prior platinum-based therapy from the dose-escalation/expansion parts of the study and the EXCLAIM extension cohort.
Methods
This 3-part, open-label, multicenter study included dose-escalation/expansion cohorts and the EXCLAIM extension cohort. Data are presented for all patients treated in EXCLAIM (N=96) and for platinum-pretreated patients from the dose-escalation/expansion cohorts (n=28) and from EXCLAIM (n=86); all received mobocertinib 160 mg orally QD. Enrolled patients had locally advanced/metastatic EGFRex20ins NSCLC, ECOG performance status 0–1, and ≥1 prior line of therapy for locally advanced/metastatic disease. The primary endpoint is confirmed ORR assessed by IRC per RECIST v1.1.
Results
In EXCLAIM, 96 patients were enrolled and treated; median age, 59 years [range: 27–80]; female, 65%; Asian, 69%; ≥2 prior systemic anticancer lines, 49% (range: 1–4). Median time on treatment was 6.5 months (range: 0–14). Confirmed ORR was 23% (22/96; 95% CI: 15%–33%) per IRC and 32% (95% CI: 23%–43%) per investigator; median DoR (Kaplan-Meier estimates) was not mature; median PFS was 7.3 months. See Table. In the analysis of platinum-pretreated patients (n=114), median age, 60 years [range: 27–84]; female, 66%; Asian, 60%; ≥2 prior systemic anticancer lines, 59% (range: 1–7). Median time on treatment was 7 months (range: 0–31); 38 patients (33%) remained on treatment as of 29-May-2020. Confirmed ORR was 26% (30/114; 95% CI: 19%–35%) per IRC and 35% (40/114; 26%–45%) per investigator. Median PFS was 7.3 months: 12-month PFS rate was 33% (95% CI: 21%–47%). Responses were observed among all prespecified subgroups, including Asian/non-Asian patients and those with/without baseline stable brain metastases. The most common treatment-related adverse events (TRAEs; ≥30%): diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%), and vomiting (30%); grade ≥3 TRAEs (≥5%): diarrhea (22%), anemia (5%), and dyspnea (5%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile observed in EXCLAIM was largely consistent with that observed in the platinum-pretreated population.
Conclusion
Mobocertinib demonstrated clinically meaningful benefit in previously treated patients with NSCLC and EGFRex20ins mutations, with a manageable safety profile.
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P85 - Targeted Therapy - Clinically Focused - MET (ID 262)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P85.04 - Capmatinib in Patients with METex14-Mutated Non-Small Cell Lung Cancer: GEOMETRY Mono-1 Asian Subgroup Analysis (ID 3101)
00:00 - 00:00 | Author(s): Tae Min Kim
- Abstract
Introduction
Capmatinib was approved for the treatment of adult patients with MET exon 14 skipping (METex14)-mutated, advanced non-small cell lung cancer (NSCLC) based on results from the global phase 2 GEOMETRY mono-1 study (NCT02414139). This sub-analysis compares the efficacy and safety of capmatinib in Asian and non-Asian patients.
Methods
Patients (≥18 years) with ECOG PS 0–1, ALK-/EGFR-wt, and stage IIIB (non-amenable to radical therapy)/stage IV NSCLC were eligible. Patients were assigned to cohorts according to MET status and number of prior lines of therapy and received capmatinib 400 mg twice daily. Efficacy results for Asian and non-Asian patients with METex14-mutated NSCLC assigned to cohorts 4 (1-2 prior lines of treatment) and 5b (treatment-naive) were compared. Safety results from all cohorts were reported. The Asian subgroup included patients enrolled in Japan, South Korea, Singapore, and Taiwan.
Results
At the time of data cut-off (April 15, 2019), 76 patients were included in the Asian subgroup (20 patients with METex14-mutated NSCLC [cohort 4, n=17; cohort 5b, n=3]) and 258 patients were included in the non-Asian subgroup (77 patients with METex14-mutated NSCLC [cohort 4, n=52; cohort 5b, n=25]). 38.2% of patients in the Asian subgroup and 29.1% in the non-Asian subgroup were non-smokers. Median duration of treatment exposure (range) was 11.9 weeks (0.7−124.6) in the Asian subgroup (15.4 weeks [1.4−83.9] for patients with METex14-mutated NSCLC) and 16.1 weeks (0.4−177) in the non-Asian subgroup (34.4 weeks [0.4−108.1] for patients with METex14-mutated NSCLC). Overall response rate among patients with METex14-mutated NSCLC regardless of line of therapy in Asian and non-Asian subgroup was 45% (95% CI: 23.1, 68.5) and 49.4% (95% CI: 37.8, 61.0), respectively. In the Asian subgroup, 2/3 patients from treatment-naive cohort 5b had partial response and 1 patient had stable disease (Table). Capmatinib was found to be safe in both subgroups. The most common treatment-related adverse events (≥20% in the Asian subgroup; any grade) reported in the Asian (n=76) versus non-Asian (n=258) subgroup were increased blood creatinine (36.8% versus 14.3%), nausea (31.6% versus 33.7%), peripheral edema (28.9% versus 45.3%), vomiting (22.4% versus 17.8%), and decreased appetite (21.1% versus 10.1%). Treatment-related adverse events leading to discontinuation were reported in 18.4% of patients in the Asian subgroup and 8.9% of patients in the non-Asian subgroup.
Table: Efficacy as per BIRC assessment
Asian
Non-Asian
Cohort 4
(2/3L)
N=17
Cohort 5b
(1L)
N=3
Cohort 4
(2/3L)
N=52
Cohort 5b
(1L)
N=25
Best overall response, n (%)
Complete response (CR)
Partial response (PR)
Stable disease (SD)
Progressive disease (PD)
Non-CR/Non-PD (NCRNPD)
Not evaluable
0
7 (41.2)
5 (29.4)
2 (11.8)
0
3 (17.6)
0
2 (66.7)
1 (33.3)
0
0
0
0
21 (40.4)
20 (38.5)
4 (7.7)
1 (1.9)
6 (11.5)
1 (4.0)
16 (64.0)
7 (28.0)
1(4.0)
0
0
Overall response rate (CR+PR), % (95% CI)
41.2 (18.4, 67.1)
66.7 (9.4, 99.2)
40.4 (27.0, 54.9)
68.0 (46.5, 85.1)
Disease control rate (CR+PR+SD+NCRNPD), % (95% CI)
70.6 (44.0, 89.7)
100 (29.2, 100)
80.8 (67.5, 90.4)
96.0 (79.6, 99.9)
Conclusion
Capmatinib demonstrated clinically meaningful efficacy and manageable safety profile in Asian patients with METex14-mutated NSCLC, consistent with the results of the overall population in GEOMETRY mono-1 study.
