For Patients and Caregivers

Survival results for ALECENSA

PFS OS

In ALK+ mNSCLC (primary analysis):

ALECENSA delivered superior mPFS vs crizotinib1 

Primary analysis

  • PFS by IRC: In the ITT population, mPFS was 25.7 months for ALECENSA (95% CI: 19.9, NE) compared with 10.4 months with crizotinib (95% CI: 7.7, 14.6); (HR=0.53 [95% CI: 0.38, 0.73]; P<0.0001)1ab 
    • Patients with event: 41% with ALECENSA (n=63/152); 61% with crizotinib (n=92/151) 
  • Median duration of follow-up: ALECENSA 18.6 months (range: 0.5-29.0 months); crizotinib 17.6 months (range: 0.3-27.0 months)5

aStratified by race (Asian vs non-Asian) and CNS metastases at baseline (yes vs no) for Cox model, log-rank test, and Cochran-Mantel-Haenszel test, respectively.

bResults for PFS as determined by INV assessment (HR=0.48; 95% CI: 0.35-0.66; P<0.0001) were similar to that observed by IRC.

Follow-up analysis

PFS by INV | 10 months later18

  • Median duration of follow-up: ALECENSA 27.8 months (range: 0.5-38.7 months); crizotinib 22.8 months (range: 0.3-36.7 months)18

The follow-up analysis was performed when approximately 50% of patients in the ALECENSA arm experienced a PFS event and was conducted for the purpose of obtaining a median estimate of PFS. No formal treatment comparisons were performed for the follow-up analysis.2

Observed in prespecified exploratory analyses:

Consistent PFS benefit with ALECENSA across a variety of patient types5

Exploratory subgroup analysis (INV) | primary analysis

Adapted from The New England Journal of Medicine, Peters S, Camidge DR, Shaw AT, et al, Alectinib versus crizotinib in untreated ALK-positive non–small-cell lung cancer, Vol 377, 829-838. Copyright© 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms. Hazard ratios were estimated from unstratified analyses.19

ALK=anaplastic lymphoma kinase; CI=confidence interval; CNS=central nervous system; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; INV=investigator; IRC=independent review committee; ITT=intent-to-treat; mNSCLC=metastatic non-small cell lung cancer; mPFS=median progression-free survival; NE=not estimable.

ALECENSA is the only TKI for ALK+ mNSCLC with 5-year exploratory OS data2

OS data observed in an exploratory analysis; data were not mature at primary cutoff and the median has still not been reached.1-3

Exploratory analysis

This post-hoc OS analysis, conducted ~5 years after randomization of the last patient, was exploratory in nature, and was not powered to show statistical significance.2,3

  • The exploratory landmark analysis included subgroups of patients with brain metastases (HR=0.62 [95% CI: 0.36, 1.05]) and without brain metastases at baseline (HR=0.79 [95% CI: 0.48, 1.3])2,3

ALK=anaplastic lymphoma kinase; CI=confidence interval; CNS=central nervous system; HR=hazard ratio; mNSCLC=metastatic non-small cell lung cancer; OS=overall survival; TKI=tyrosine kinase inhibitor.

For more information

View safety profile
View response rates & CNS results

Indications & Important Safety Information

Indications

ALECENSA is a kinase inhibitor indicated for:

  • treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test
  • adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥4 cm or node positive), as detected by an FDA-approved test

Warnings and Precautions

Hepatotoxicity

  • Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with ALECENSA. Hepatotoxicity occurred in 41% of 533 patients treated with ALECENSA and the incidence of Grade ≥3 hepatotoxicity was 8%. In the ALINA study, hepatotoxicity occurred in 61% of patients treated with ALECENSA and the incidence of Grade ≥3 hepatotoxicity was 4.7%. The majority (72% of 136 patients) of elevated transaminases occurred during the first 3 months of treatment. Treatment discontinuation due to hepatotoxicity occurred in 3.6% of patients who received ALECENSA in the pooled safety population and 1.6% of patients treated in the ALINA study
  • Concurrent elevations in alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 3 times the ULN and total bilirubin greater than or equal to 2 times the ULN, with normal alkaline phosphatase, occurred in less than 1% of patients treated with ALECENSA. Three patients with Grades 3-4 AST/ALT elevations had drug-induced liver injury (documented by liver biopsy in 2 cases)
  • Monitor liver function tests including ALT, AST, and total bilirubin every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse drug reaction, withhold ALECENSA and resume at a reduced dose, or permanently discontinue ALECENSA

Interstitial Lung Disease (ILD)/Pneumonitis

  • ILD/pneumonitis occurred in 1.3% of 533 patients treated with ALECENSA with 0.4% of patients experiencing Grade 3 ILD/pneumonitis. Five patients (0.9%) discontinued ALECENSA due to ILD/pneumonitis. The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 2.1 months (range: 0.6 months to 3.6 months)
  • Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever)
  • Immediately withhold ALECENSA treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified

Renal Impairment

  • Renal impairment occurred in 12% of 533 patients treated with ALECENSA, including Grade ≥3 in 1.7% of patients, of which 0.4% were fatal events
  • The median time to Grade ≥3 renal impairment was 3.7 months (range 0.5 to 31.8 months). Dosage modifications for renal impairment were required in 2.4% of patients
  • Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold ALECENSA for Grade 3 renal toxicity until recovery to less than or equal to 1.5 times ULN, then resume at reduced dose

Bradycardia

  • Symptomatic bradycardia occurred in patients treated with ALECENSA. Bradycardia occurred in 11% of 533 patients treated with ALECENSA. Twenty percent of 521 patients for whom serial electrocardiograms (ECGs) were available had post-dose heart rates of less than 50 beats per minute (bpm)
  • Monitor heart rate and blood pressure regularly. For asymptomatic bradycardia, dose modification is not required. For symptomatic bradycardia that is not life-threatening, withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate ≥60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If bradycardia is attributable to a concomitant medication, resume ALECENSA at a reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated
  • Permanently discontinue ALECENSA in cases of life-threatening bradycardia if no contributing concomitant medication is identified or for recurrence of life-threatening bradycardia

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation

  • Severe myalgia and creatine phosphokinase (CPK) elevation occurred in patients treated with ALECENSA. Myalgia (including muscle- and musculoskeletal-related reactions) occurred in 31% of 533 patients treated with ALECENSA, including Grade ≥3 in 0.8% of patients. Dosage modifications for myalgia events were required in 2.1% of patients
  • Of the 491 with CPK laboratory data available, elevated CPK occurred in 56% of patients, including 6% Grade ≥3. The median time to Grade ≥3 CPK elevation was 15 days (interquartile range 15-337 days). Dosage modifications for elevation of CPK occurred in 5% of patients. In the ALINA study, elevated CPK occurred in 77% of 128 patients with CPK laboratory data, including 6% Grade ≥3 elevations
  • Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold ALECENSA, then resume or reduce dose

Hemolytic Anemia

  • Hemolytic anemia occurred in patients treated with ALECENSA. Hemolytic anemia was initially reported with ALECENSA in the postmarketing setting, including cases associated with a negative direct antiglobulin test (DAT) result. Assessments for the determination of hemolytic anemia were subsequently collected in the ALINA study, where hemolytic anemia was observed in 3.1% of patients treated with ALECENSA
  • If hemolytic anemia is suspected, withhold ALECENSA and initiate appropriate laboratory testing. If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue ALECENSA

Embryo-Fetal Toxicity

  • ALECENSA can cause fetal harm when administered to pregnant women. Administration of alectinib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans with alectinib 600 mg twice daily. Advise pregnant women of the potential risk to a fetus
  • Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 5 weeks following the last dose
  • Advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the last dose

Most Common Adverse Reactions

  • The most common adverse reactions (≥20%) were hepatotoxicity (41%), constipation (39%), fatigue (36%), myalgia (31%), edema (29%), rash (23%), and cough (21%)

Use in Specific Populations

Lactation

  • Because of the potential for serious adverse reactions in breastfed infants from ALECENSA, advise a lactating woman not to breastfeed during treatment with ALECENSA and for 1 week after the last dose

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see additional Important Safety Information in full Prescribing Information.

    • ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc. 2024.

      ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc. 2024.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

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      Mok T, Camidge DR, Gadgeel SM, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31(8):1056-1064. doi:10.1016/j.annonc.2020.04.478

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.4.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 29, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines® for detailed recommendations.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.4.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 29, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines® for detailed recommendations.

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