Study Design

ORR and CNS ORR

Adverse Reactions

ALECENSA® (alectinib) Was Studied in Multiple Clinical Trials

Study NP28761—North American Trial Design 1,3

  • Single-arm, North American, multicenter study 1

  • Median duration of follow up: 4.8 months (IRC, INV) 1

  • Patients may have received prior chemotherapy 1

Study—NP28673 International Trial Design 1,3 

  • Single-arm, international, multicenter study 1

  • Median duration of follow-up: 10.9 months (IRC); 7.0 months (INV) 1

  • Patients may have received prior chemotherapy 1

Patients in both studies were required to have documented ALK+ NSCLC based on an FDA-approved test and ECOG PS of 0-2. 1

aAssessed according to RECIST v1.1. 1

Patient Characteristics in Two Phase 2 Clinical Trials

Baseline Characteristics 1,3

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ALECENSA Demonstrated Meaningful and Durable Objective Responses

ORR in the North American and International Studies 1

  • The major efficacy outcome measure in both studies was ORR according to RECIST v1.1 as evaluated per IRC 1

  • 18 patients in the North American study and 16 patients in the International study did not have measurable disease at baseline per IRC assessment and were classified as non-responders in the IRC analysis 1

  • All responses were partial responses 1

Median DOR 1

  • The median duration of follow-up for the North American study was 4.8 months for both IRC and Investigator assessments and for the International study, 10.9 months for IRC assessment and 7.0 months for Investigator assessment 1

ALECENSA Delivered Robust and Sustained CNS Responses

CNS ORR in Patients With Measurable Lesions | IRC 

  • The ORR in CNS metastases in the subgroup of 51 patients with measurable lesions in the CNS at baseline was assessed by IRC and determined by RECIST v1.1 in both studies 1

  • 35 (69%) patients with measurable CNS lesions received prior brain radiation, including 25 (49%) who completed radiation treatment at least 6 months before starting treatment with ALECENSA 1

CNS responses were observed irrespective of prior brain radiation status. 1

Median CNS DOR in the North American & International Studies 1 | IRC

  • The DOR in CNS metastases in the subgroup of 51 patients with measurable lesions in the CNS at baseline was assessed by IRC and determined by RECIST v1.1 in both studies 1

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Adverse Reactions Post-Crizotinib Treatment

Adverse reactions from clinical trial experience 1

  • Serious adverse reactions occurred in 19% of patients, and the most frequently reported serious adverse reactions were pulmonary embolism (1.2%), dyspnea (1.2%), and hyperbilirubinemia (1.2%) 1

  • Fatal adverse reactions occurred in 2.8% of patients, and included hemorrhage (0.8%), intestinal perforation (0.4%), dyspnea (0.4%), pulmonary embolism (0.4%), and endocarditis (0.4%) 1

Adverse Reactions in ≥10% (All Grades) or ≥2% (Grade 3-4) of Patients in the North American & International Studies 1

bPer CTCAE version 4.0.
cIncludes fatigue and asthenia.
dIncludes peripheral edema, edema, generalized edema, eyelid edema, and periorbital edema.
eIncludes myalgia and musculoskeletal pain.
fIncludes rash, maculopapular rash, acneiform dermatitis, erythema, generalized rash, papular rash, pruritic rash, and macular rash.
gIncludes 1 Grade 5 event.
hIncludes blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, and diplopia. 

Incidence of photosensitivity in clinical trials 1

  • Photosensitivity occurred in 9.9% of patients exposed to ALECENSA in both studies

  • Patients were advised to avoid sun exposure and to use broad-spectrum sunscreen

  • The incidence of Grade 2 photosensitivity was 0.4% and the remaining events were Grade 1 in severity

23% of patients initiating treatment at the recommended dose required at least 1 dose reduction 1

6% of patients treated with ALECENSA in clinical trials permanently discontinued treatment due to adverse reactions 1

Dose modifications due to adverse reactions in clinical trials 1

  • The most frequent adverse reactions that led to permanent discontinuation were hyperbilirubinemia (1.6%), increased ALT levels (1.6%), and increased AST levels (1.2%) 

  • The most frequent adverse reactions that led to dose reductions or interruptions were elevations in bilirubin (6%), CPK (4.3%), ALT (4%), AST (2.8%), and vomiting (2.8%)

  • The median time to first dose reduction was 48 days

Laboratory Abnormalities Occurring in >20% of Patients in Both Studies 1

iPer CTCAE version 4.0.
jn=218 for CPK (with baseline values missing for 91 of these patients).
kn=152 for fasting blood glucose (with baseline values missing for 5 of these patients).
lOnly patients with creatinine increases based on ULN definition.
mn=217 for lymphocytes (with baseline values missing for 5 of these patients).

1L=first-line; ALT=alanine transaminase; AST=aspartate transaminase; CI=confidence interval; CNS=central nervous system; CPK=creatine phosphokinase; CR=complete response; CTCAE=common terminology criteria for adverse events; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; INV=Investigator; IRC=Independent Review Committee; NE=not estimable; ORR=objective response rate; PFS=progression-free survival; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; ULN=upper limit of normal.

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1L PFS Results

View PFS results vs crizotinib from the head-to-head ALEX trial.

CNS Efficacy in 1L ALK+ mNSCLC

Learn more about CNS efficacy with ALECENSA.

Financial Support for Patients

Learn more about ALECENSA patient and practice resources.