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Treatment Naive
Previously Treated
Post Hoc Analysis: Brain Mets

Powerful and sustained responses in treatment-naive patients (n=60)2,3

68% overall response rate and 16.6 months median duration of response in treatment-naive patients

In the GEOMETRY mono-1 pivotal trial, TABRECTA® (capmatinib) tablets delivered an overall response rate (ORR) of 68% and a median duration of response (mDOR) of over 1 year (16.6 months) in treatment-naive patients (n=60). 


CR, complete response; PR, partial response. 
 

Highlights of Important Safety Information

TABRECTA has Warnings and Precautions for interstitial lung disease (ILD/pneumonitis), hepatotoxicity, pancreatic toxicity, hypersensitivity reactions, risk of photosensitivity, and embryo-fetal toxicity.

The most common adverse reactions (≥20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.


Please see additional Important Safety Information below.

 


Other efficacy outcomes3

  • The majority of patients taking TABRECTA® (capmatinib) tablets responded within ~7 weeks


98.3% DCR

(95% CI, 91.1-100.0) 
 

Disease control rate (DCR) was an exploratory efficacy outcome that accounted for CR + PR + SD + non-CR/non-PD, which may reflect the natural history of disease in an individual patient rather than the therapeutic effect of the treatment.


Noncomparative analysis of median PFS and OS

Due to the nonrandomized, noncomparative nature of the study, progression-free survival (PFS) and overall survival (OS) results are difficult to interpret. No statistical tests were made for PFS and OS, as there was no comparator arm. PFS and OS results are based on an interim analysis; results are subject to change pending longer trial follow-up.

12.45-month median PFS
25.49-month median OS

(95% CI, 8.31-17.97; 37 of 60 [61.7%] event rate)

(95% CI, 15.24-NE; 30 of 60 [50.0%] event rate)

NE, not estimable; PD, progressive disease; SD, stable disease.

 Start strong with TABRECTA® (capmatinib) tablets 

Starting strong with TABRECTA in previously treated patients (n=100)2,3

  • 44% ORR (95% CI, 34-54; CR, 0; PR, 44 [44%])

  • 9.7-month mDOR (95% CI, 5.6-13.0; n=44)

    • Percentage of patients with responses at ≥12 months was 36%

2L therapy 
(Cohort 6, n=31)*
51.6% overall response rate and 9.05 months median duration of response in 2L patients
2L/3L therapy 
(Cohort 4, n=69)†
40.6% overall response rate and 9.72 months median duration of response in 2L/3L patients

In the GEOMETRY mono-1 pivotal trial, TABRECTA® (capmatinib) tablets delivered an overall response rate (ORR) of 51.6% and a median duration of response (mDOR) of 9.05 months in patients treated with 1 prior line of therapy (n=31).*

In patients treated with 1 or 2 prior lines of therapy (n=69)†, TABRECTA delivered an ORR of 40.6% and an mDOR of 9.72 months.

2L, second-line; 3L, third-line. 
*One patient in Cohort 6 received 3 prior lines of systemic therapy. 
†2 patients in Cohort 4 received 3 prior lines of systemic therapy.

Highlights of Important Safety Information

TABRECTA has Warnings and Precautions for interstitial lung disease (ILD/pneumonitis), hepatotoxicity, pancreatic toxicity, hypersensitivity reactions, risk of photosensitivity, and embryo-fetal toxicity.

The most common adverse reactions (≥20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.

Please see additional Important Safety Information below.

 


Other efficacy outcomes3

2L

2L/3L

90.3% DCR
78.3% DCR

(95% CI, 74.2-98.0)

(95% CI, 66.7-87.3)

Disease control rate (DCR) was an exploratory efficacy outcome that accounted for CR + PR + SD + non-CR/non-PD, which may reflect the natural history of disease in an individual patient rather than the therapeutic effect of the treatment. 

 

Noncomparative analysis of median PFS and OS

Due to the nonrandomized, noncomparative nature of the study, progression-free survival (PFS) and overall survival (OS) results are difficult to interpret. No statistical tests were made for PFS and OS, as there was no comparator arm. PFS and OS results are based on an interim analysis; results are subject to change pending longer trial follow-up.

2L

2L/3L

6.93-month median PFS
5.42-month median PFS

(95% CI, 4.17-13.34; 23 of 31 [74.2%] event rate)

(95% CI, 4.17-6.97; 60 of 69 [87.0%] event rate)

2L

2L/3L

24.28-month median OS
13.57-month median OS

(95% CI, 13.54-NE; 17 of 31 [54.8%] event rate)

(95% CI, 8.61-22.24; 53 of 69 [76.8%] event rate)

Post hoc analysis

 

In a post hoc analysis, intracranial responses were observed in patients with brain lesions at baseline (n=13)


Thirteen evaluable patients in the cohorts with METex14 (n=97) had brain metastases at baseline, as assessed by a BIRC5

  • Seven of 13 patients (54%) had not received prior brain radiotherapy6


Intracranial response with TABRECTA® (capmatinib) tablets: 54% (n=7 of 13)5

  • Complete resolution: 31% (n=4 of 13)

  • Partial resolution: 23% (n=3 of 13)


Intracranial disease control rate: 92% (n=12 of 13)5

Intracranial disease control rate was an exploratory efficacy outcome that accounted for CR + PR + SD + non-CR/non-PD, and may reflect the natural history of disease in an individual patient rather than the therapeutic effect of the treatment.


This analysis of overall intracranial response rate included patients with measurable brain disease at baseline and at least one postbaseline assessment but omits brain imaging in patients with premature discontinuations, which may lead to bias favoring a treatment effect.

If brain lesions were documented at baseline, computed tomography with intravenous contrast or a magnetic resonance imaging scan was mandated every 6 weeks, or otherwise, only if clinically indicated.4

Results are based on a noncomparative post hoc analysis and are observational in nature; as such, they should be interpreted with caution.

Study design

GEOMETRY mono-1: a multicohort, nonrandomized, open-label Phase II trial2-4
Study design

The efficacy population included 60 treatment-naive patients (28 patients in Cohort 5b and 32 patients in Cohort 7) and 100 previously treated patients (69 patients in Cohort 4 and 31 patients in Cohort 6). To be eligible for Cohort 4, patients must have failed 1 or 2 prior lines of systemic therapy. To be eligible for Cohort 6, patients must have failed 1 prior line of systemic therapy. Among previously treated patients, 81% received 1, 16% received 2, and 3% received 3 prior lines of systemic therapy, and 86% received prior platinum-based chemotherapy. Evaluable patients were defined as those who completed at least 6 cycles of treatment (18 weeks) or discontinued treatment earlier. Patients with symptomatic CNS metastases, clinically significant uncontrolled cardiac disease, or who received treatment with any MET or HGF inhibitor were not eligible for the study.

  • Major efficacy outcome: Overall response rate*
  • Additional efficacy outcome: Duration of response*
  • Other outcomes: Time to response, disease control rate, progression-free survival, overall survival, safety 


ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; HGF, hepatocyte growth factor; MET, mesenchymal-epithelial transition; METex14, MET exon 14 skipping; NSCLC, non-small cell lung cancer; RECIST, Response Evaluation Criteria in Solid Tumors. 
*As determined by a blinded independent review committee (BIRC) according to RECIST 1.1.