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Daniel S. W. Tan



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    OA01 - Precision Medicine and Personalized Therapy for Lung Cancer (ID 1)

    • Event: NACLC 2019
    • Type: Oral Abstract Session
    • Track:
    • Presentations: 1
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      OA01.07 - Capmatinib (INC280) in METΔex14-mutated Advanced NSCLC: Efficacy Data from the Phase 2 GEOMETRY Mono-1 Study (ID 54)

      14:00 - 15:40  |  Author(s): Daniel S. W. Tan

      • Abstract
      • Slides

      Background:
      Capmatinib is a highly potent, selective MET-inhibitor known to cross the BBB, and intracranial activity with capmatinib has been previously reported. Updated results for overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and brain metastases (BM) activity from the GEOMETRY mono-1 study are presented here.


      Method:
      GEOMETRY mono-1 is a phase 2, multi-cohort, multicenter study evaluating capmatinib in MET?ex14-mutated or MET-amplified NSCLC patients. Patients (?18 years) with ECOG PS 0–1, ALK-/EGFR-wt, and stage IIIB/IV NSCLC were eligible. Patients with asymptomatic BM were allowed. MET?ex14-mutated patients were assigned to Cohorts 4 (1-2 prior lines of treatment) and 5b (treatment-naive) and received capmatinib 400mg BID. Endpoints by BIRC: ORR (primary, RECIST v1.1), DOR, and PFS. Ad hoc BIRC neuro-radiologic assessments of all Cohort 4 and 5b patients with baseline BM were performed.


      Results:
      As of April 15, 2019, 97 patients (Cohort 4: 69 patients; Cohort 5b: 28 patients) were evaluable for efficacy. BIRC assessments: ORR (95% CI): 40.6% (28.9-53.1) in Cohort 4; 67.9% (47.6-84.1) in Cohort 5b. Median DOR (95% CI): 9.7 (5.55-12.98) and 11.1 (5.55-NE) months and median PFS (95% CI): 5.4 (4.17-6.97) and 9.7 (5.52-13.86) months for Cohorts 4 and 5b, respectively. Of 13 evaluable patients with BM at baseline, 7 (54%) had intracranial response by BIRC, including 4 patients with complete resolution of brain lesions, and 12/13 had intracranial disease control. Responses in the brain were as fast as systemic responses. Most common treatment-related AEs (?15%, all grades) across all cohorts (N=334): peripheral edema (41.6%), nausea (33.2%), increased blood creatinine (19.5%), and vomiting (18.9%); most AEs were grade 1/2.


      Conclusion:
      These data confirm capmatinib to be a promising new treatment option for patients with MET?ex14-mutated advanced NSCLC regardless of line of therapy, with deep and durable responses including in patients with brain metastases, and a manageable toxicity profile.

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    PD01 - Poster Discussion Session (ID 4)

    • Event: NACLC 2019
    • Type: Poster Discussion Session
    • Track:
    • Presentations: 1
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      PD01.05 - CANOPY-1: Phase 3 Study of Canakinumab/Placebo+Pembrolizumab+Platinum-chemotherapy in Untreated Stage IIIB-IV NSCLC Patients (ID 70)

      15:45 - 16:45  |  Author(s): Daniel S. W. Tan

      • Abstract

      Background:
      Interleukin-1? (IL-1?) inhibition with canakinumab reduced the incidence of and mortality due to lung cancer among patients with atherosclerosis in CANTOS trial. Inhibition of IL-1? driven inflammation may lead to a tumor microenvironment more susceptible to anti-PD-(L)1 therapies. Recent studies have shown that low levels of C-reactive protein (CRP) at baseline or decreased levels over time correlated with improved responses to anti-PD-(L)1 agents, providing rationale for combination of canakinumab and Pembrolizumab (PEM).


      Method:
      CANOPY-1 (NCT03631199) is a double-blind, randomized, placebo (Pb)-controlled, phase III trial to determine efficacy and safety of PEM + platinum-based chemotherapy (Ctx) ± canakinumab in untreated stage IIIB/IIIC-IV squamous and non-squamous NSCLC patients (pts). It is a 2 part study- In Part 1 [open-label safety run-in with 3 cohorts of ~9 pts each to confirm recommended phase 3 canakinumab regimen], pts will receive canakinumab 200 mg s.c (Q3W) + PEM 200 mg i.v (Q3W) + platinum-based Ctx [Cohort A (non-squamous), carboplatin (CBCDA) + pemetrexed (PTX); Cohort B (non-squamous), cisplatin + PTX; Cohort C (squamous or non-squamous), CBCDA + paclitaxel]. In Part 2 [with ~600 pts) to evaluate efficacy and safety of canakinumab combination], pts will be randomized to receive canakinumab/Pb + PEM + platinum-based Ctx (non-squamous, CBCDA or cisplatin + PTX; squamous, CBCDA + paclitaxel or nab-paclitaxel). PEM and platinum-based Ctx will be administered at their approved doses. Randomization (1:1) will be stratified by PD-L1 status, region and histology. In both parts, pts will receive 4 cycles of induction therapy (canakinumab/Pb + PEM + Ctx) followed by maintenance therapy (PEM + canakinumab/Pb +/- PTX) until progressive disease. Primary objectives: confirm recommended phase 3 regimen for canakinumab combination (Part 1), compare PFS and OS between treatment arms (Part 2). Secondary objectives (Part 1 and 2): ORR, DCR, safety, PK and DOR.


      Results:
      Not applicable.


      Conclusion:
      Not applicable.