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M. Thomas
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P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.04-005 - GEOMETRY Mono-1: Phase II, Multicenter Study of MET Inhibitor Capmatinib (INC280) in EGFR Wt, MET-Dysregulated Advanced NSCLC (ID 8961)
09:30 - 09:30 | Author(s): M. Thomas
- Abstract
Background:
Amplification of MET leading to oncogenic signaling occurs in 3‒5% of newly diagnosed EGFR wild type (wt) non-small cell lung cancer (NSCLC) cases with decreasing incidence at higher levels of amplification. Mutations in MET leading to exon 14 deletion (METΔ[ex14]) also occur in 2–4% of adenocarcinoma and 1–2% of other NSCLC subsets. Capmatinib (INC280) is a potent and selective MET inhibitor that has shown strong evidence of antitumor activity in a phase I study in patients with EGFR wt advanced NSCLC harboring MET amplification and METΔ[ex14].
Method:
This phase II, multicenter study (NCT02414139) was designed to confirm the clinical activity of capmatinib in patients with advanced NSCLC by MET amplification and METΔ[ex14] status. Eligible patients (≥18 years of age, Eastern Cooperative Oncology Group Performance Status 0–1) must have ALK-negative, EGFR wt, stage IIIB/IV NSCLC (any histology). Centrally assessed MET amplification (gene copy number [GCN]) and mutation status is used to assign patients to one of the below cohorts: Pretreated with 1–2 prior systemic lines of therapy for advanced setting (cohorts 1–4): 1a: MET amplification GCN ≥10 (n=69) 1b: MET amplification GCN ≥6 and <10 (n=69) 2: MET amplification GCN ≥4 and <6 (n=69) 3: MET amplification GCN <4 (n=69) 4: METΔ[ex14] mutation regardless of MET GCN (n=69) Treatment naïve (cohorts 5a and 5b): 5a: MET amplification GCN ≥10 and no METΔ[ex14] mutation (n=27) 5b: METΔ[ex14] mutation regardless of MET GCN (n=27) Capmatinib 400 mg tablets are orally administered twice daily on a continuous dosing schedule 12 hours apart. Primary and key secondary endpoints are overall response rate (ORR) and duration of response (DOR), respectively (blinded independent review assessment). Other secondary endpoints include investigator-assessed ORR, DOR, time to response, disease control rate, progression-free survival (independent and investigator assessment), safety, and pharmacokinetics. Enrollment is ongoing in 25 countries. Cohorts 1b, 2, and 3 are now closed to enrollment; cohorts 1a and 4 continue to enroll patients who have received 1–2 prior lines of therapy in the advanced setting, and cohorts 5a and 5b are open for enrollment of treatment-naïve patients. Responses have been seen in both MET-amplified and MET-mutated patients irrespective of the line of therapy.
Result:
Section not applicable
Conclusion:
Section not applicable
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-088 - Molecular Testing and First-Line Treatment of Patients with NSCLC. First Results from the German CRISP Study (AIO-TRK-0315) (ID 9960)
09:30 - 09:30 | Author(s): M. Thomas
- Abstract
Background:
Treatment of non-small cell lung cancer (NSCLC) is quickly evolving. New biomarkers and targeted agents have been approved at a rapid pace. It is of high interest to patients, physicians and reimbursement institutions to investigate molecular testing and subsequent treatment decisions in routine practice.
Method:
The prospective, national clinical research platform CRISP recruits patients in up to 150 cancer centres in all therapeutic sectors in Germany. Patients will be followed until death or for a maximum of 3 years. Raw data from 717 patients recruited by 78 centers by April 03[rd] was analysed regarding molecular testing and 1[st]-line treatment.
Result:
Data on histology was available for 635 patients, 71% non-squamous carcinoma (nsqc), 18% squamous carcinoma (sqc). Median age was 67 years and 61% of patients were male. 11% of patients were never smokers. In patients with nsqc (n=507) molecular test rates for EGFR, ALK, ROS-1 and PD-L1 were 69%, 65%, 51% and 26%, respectively. The overall PD-L1 test rate (nsqc & sqc) was 21% in 2016 and has been 27% so far in 2017. Of patients for whom test results were available at time of analysis 58% (n=87) were PD-L1 positive (nsqc 60%, n=76 and sqc 46%, n=11). An EGFR alteration was detected in 16% (n=57), an ALK alteration in 8% (n=25), and a ROS-1 alteration in 4% (n=9) of nsqc patients. Overall, 53% of patients received a carboplatin-based, 22% a cisplatin-based, and 7% a platin-free chemotherapy, while 14% received targeted and 4% other (experimental) therapies. Patients with EGFR alterations (n=57) were most frequently treated with 1[st]-line afatinib (33%), erlotinib (12%), or gefitinib (11%). Patients with ALK alterations (n=25) were most frequently treated with 1[st]-line crizotinib (48%). Patients with PD-L1 positive tumours were most frequently treated with platinum based doublet therapies (carboplatin combined with gemcitabine/taxane/pemetrexed or cisplatin combined with pemetrexed) or with pembrolizumab. The use of 1[st]-line pembrolizumab increased from 7% to 16% from 2016 to 2017. An update with data collected until October 2017 (>1,100 patients expected) will be presented.
Conclusion:
For the first time, CRISP presents real life data from all therapeutic sectors in Germany. Patients are frequently tested for molecular alterations and more than half of the patients with molecular alterations can start 1[st]-line treatment with a targeted therapy. Supported by AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer and Roche.
