Powerful and sustained responses in treatment-naive patients (n=60)2,3
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
12.45-month median PFS
25.49-month median OS
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)*
2L/3L therapy (Cohort 4, n=69)†
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
90.3% DCR
(95% CI, 74.2-98.0)
2L/3L
78.3% DCR
(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
6.93-month median PFS
(95% CI, 4.17-13.34; 23 of 31 [74.2%] event rate)
2L/3L
5.42-month median PFS
(95% CI, 4.17-6.97; 60 of 69 [87.0%] event rate)
2L
24.28-month median OS
(95% CI, 13.54-NE; 17 of 31 [54.8%] event rate)
2L/3L
13.57-month median OS
(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
INDICATION
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.9% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.
Indication
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.9% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.
Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/ pneumonitis are identified.
Hepatotoxicity. Hepatotoxicity occurred in patients treated with TABRECTA. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 15% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 7% of patients. Three patients (0.8%) discontinued TABRECTA due to increased ALT/AST.
Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA.
Pancreatic Toxicity. Elevations in amylase and lipase levels have occurred in patients treated with TABRECTA. Increased amylase/lipase occurred in 14% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased amylase/lipase occurred in 7% and 1.9% of patients, respectively. Three patients (0.8%) discontinued TABRECTA due to increased amylase/lipase. Pancreatitis (grade 3) occurred in 1 patient (0.3%); TABRECTA was permanently discontinued for this event.
Monitor amylase and lipase at baseline and regularly during treatment with TABRECTA. Based on the severity of the adverse reaction, temporarily withhold, dose reduce, or permanently discontinue TABRECTA.
Hypersensitivity Reactions. Serious hypersensitivity reactions occurred in patients treated with TABRECTA in clinical trials other than GEOMETRY mono-1. Signs and symptoms of hypersensitivity included pyrexia, chills, pruritus, rash, decreased blood pressure, nausea, and vomiting. Based on the severity of the adverse reaction, temporarily withhold or permanently discontinue TABRECTA.
Risk of Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure, such as use of sunscreen or protective clothing, during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA.
Embryo-Fetal Toxicity. Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose.
Most Common Adverse Reactions. The most common adverse reactions (≥20%) were edema (59%), nausea (46%), musculoskeletal pain (40%), fatigue (34%), vomiting (28%), dyspnea (25%), cough (21%), and decreased appetite (21%). The most common grade 3 adverse reactions (≥2%) were edema (13%), fatigue (8%), dyspnea (7%), pneumonia (6%), musculoskeletal pain (4.3%), nausea (2.4%), and vomiting (2.4%). Grade 4 dyspnea and pneumonia were reported in 0.5% of patients.
Clinically Relevant Adverse Reactions. Clinically relevant adverse reactions observed in <10% of patients were pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.
Laboratory Abnormalities. Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA were decreased albumin (72%), increased creatinine (65%), decreased lymphocytes (45%), increased ALT (39%), increased amylase (34%), increased alkaline phosphatase (32%), increased gamma-glutamyltransferase (30%), increased lipase (29%), increased AST (28%), decreased phosphate (26%), decreased leukocytes (25%), increased potassium (25%), decreased hemoglobin (24%), decreased sodium (24%), and decreased glucose (23%).
Please see full Prescribing Information for TABRECTA.
