Treatment with ZYKADIA may cause GI Adverse Reactions, Hepatic and Embryo-fetal Toxicities, Interstitial Lung Disease/Pneumonitis, QTc Interval Prolongation, Hyperglycemia, Bradycardia, Pancreatiti...
LET THE ALK INHIBITOR ZYKADIA BE YOUR FIRST-LINE CHOICE
EFFICACY AND SAFETY OF ZYKADIA® (ceritinib) IN PATIENTS WITH PREVIOUSLY UNTREATED ALK+ METASTATIC NSCLC ESTABLISHED IN AN OPEN-LABEL, RANDOMIZED, ACTIVE-CONTROLLED, MULTICENTER STUDY (ASCEND-4)1,2
In a dose optimization study (ASCEND-8), ZYKADIA 450 mg once daily with food was compared with 750 mg once daily under fasted conditions in both previously treated and untreated patients with ALK+ metastatic NSCLC. There was no clinically meaningful difference in the systemic steady-state exposure of ZYKADIA for the 450-mg once-daily with food arm compared with the 750-mg once-daily fasted arm.1
The recommended dose of 450 mg once daily with food was established as the safe and efficacious recommended dose of ZYKADIA.1
For more information on ASCEND-8, please click here.
AUC, area under the curve; BIRC, blinded independent review committee; DOIR, duration of intracranial response; DOR, duration of response; OIRR, overall intracranial response rate; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PROs, patient-reported outcomes; WHO, World Health Organization.
aExcept neoadjuvant or adjuvant systemic therapy (if relapse had occurred >12 months from the end of therapy).
bPemetrexed 500 mg/m2 + cisplatin 75 mg/m2 or pemetrexed 500 mg/m2 + carboplatin AUC 5-6 mg•min/mL; 1 cycle=21 days.
cOnly patients without progressive disease continued to maintenance treatment.
*As determined by BIRC.
†As determined by BIRC neuroradiologist.
‡Safety analyses were done in patients who received at least 1 dose of study drug (safety set).
APPROVED FOR FIRST-LINE USE IN PATIENTS WITH ALK+ METASTATIC NSCLC
PATIENT CHARACTERISTICS IN THE PREVIOUSLY UNTREATED CLINICAL STUDY1
START WITH POWERFUL FIRST-LINE EFFICACY
PFS IN OVERALL PATIENT POPULATION, WITH AND WITHOUT BRAIN METASTASES1
BIRC, blinded independent review committee; HR, hazard ratio; PFS, progression-free survival.
*As determined by BIRC.
ADDITIONAL SECONDARY OUTCOME MEASURES, INCLUDING OVERALL SURVIVAL, TUMOR RESPONSE, AND PATIENT-REPORTED OUTCOMES†
DOR, duration of response; NE, not estimable; ORR, overall response rate; OS, overall survival.
†The key secondary end point was OS. Other secondary end points included ORR, DOR determined by BIRC, and patient-reported outcomes.1,2
ZYKADIA SHOWED ANTITUMOR ACTIVITY IN THE BRAIN IN A SUBGROUP ANALYSIS OF PATIENTS WITH BRAIN METASTASES
MORE THAN DOUBLE THE OIRR WITH ZYKADIA IN PATIENTS WITH MEASURABLE BRAIN METASTASES1
BIRC, blinded independent review committee; CR, complete response; OIRR, overall intracranial response rate; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumors.
CNS RESPONSE IN PREVIOUSLY UNTREATED PATIENTS WITH BRAIN METASTASES (SUBGROUP ANALYSIS)
DOIR IN PATIENTS WITH BRAIN METASTASES (BIRC ASSESSED)1
CNS, central nervous system; DOIR, duration of intracranial response; NE, not estimable.
IMPORTANT SAFETY INFORMATION
EFFICACY AND SAFETY IN PREVIOUSLY TREATED PATIENTS WITH ALK+ METASTATIC NSCLC ESTABLISHED IN ASCEND-1 REGISTRATION STUDY1,3
The efficacy and safety of ZYKADIA in previously treated patients was established in a multicenter, single-arm, open-label phase 1 clinical trial:
In a dose optimization study (ASCEND-8), ZYKADIA 450 mg once daily with food was compared with 750 mg once daily under fasted conditions in both previously treated and untreated patients with ALK+ metastatic NSCLC. There was no clinically meaningful difference in the systemic steady-state exposure of ZYKADIA for the 450-mg once-daily with food arm compared with the 750-mg once-daily fasted arm.1
The recommended dose of 450 mg once daily with food was established as the safe and efficacious recommended dose of ZYKADIA.1
For more information on ASCEND-8, please click here.
BIRC, blinded independent review committee; DOR, duration of response; ORR, overall response rate; RECIST, Response Evaluation Criteria In Solid Tumors.
aMajor efficacy outcome measure was ORR according to RECIST v1.0 as evaluated by both investigators and a BIRC.
bAdditional outcome measure was DOR according to RECIST v1.0 as evaluated by both investigators and a BIRC.
ZYKADIA DELIVERED CLINICAL RESPONSE IN 55% OF PATIENTS AFTER PROGRESSION OR INTOLERANCE ON CRIZOTINIB BASED ON INVESTIGATOR ASSESSMENT1
CLINICAL RESPONSE WITH ZYKADIA1,a
ZYKADIA DELIVERED A MEDIAN DURATION OF RESPONSE OF 7.4 MONTHS BASED ON INVESTIGATOR ASSESSMENT1
CLINICAL RESPONSE WITH ZYKADIA1,3,b
BIRC, blinded independent review committee; CR, complete response; DOR, duration of response; NE, not estimable; ORR, overall response rate; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumors.
aClinical efficacy was evaluated in 163 patients after progression on crizotinib.
bORR and DOR were determined by RECIST v1.0.
cDOR, which applies only to patients who achieved CR or PR, is the time from first documented response (CR or PR) to the date of first documented progression or death due to any cause.
References: 1. Zykadia [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017. 2. Soria J-C, Tan DSW, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017;389(10072):917-929. 3. Data on file. Novartis Pharmaceuticals Corp; 2011.
INDICATION
ZYKADIA® (ceritinib) capsules is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION for ZYKADIA® (ceritinib) capsules
Gastrointestinal Adverse Reactions
Hepatotoxicity
Interstitial Lung Disease/Pneumonitis
QTc Interval Prolongation
Hyperglycemia
Bradycardia
Pancreatitis
Embryo-fetal Toxicity
Lactation
Adverse Reactions
Drug Interactions
Effect of Other Drugs on Ceritinib
Effect of Ceritinib on Other Drugs
Drug-Food/Drink Interactions
Please see full Prescribing Information for ZYKADIA® (ceritinib) capsules.