See why ALECENSA is prescribed more than any other 1L treatment for ALK+ mNSCLC¹

ALECENSA achieved mPFS >2 years at primary analysis and ~3 years at exploratory follow-up analysis^2,15a

^aThe exploratory follow-up, conducted 10 months later, was assessed by investigators, and no formal treatment comparisons were performed.^4,15

While median OS was not reached at primary data cutoff, 60% of patients who started on ALECENSA are still alive at 5 years in a post-hoc analysis^4,20b

^bThis post-hoc OS analysis, conducted at ~5 years after randomization of the last patient, was exploratory in nature, and was not powered to show statistical significance.^4,20

See why ALECENSA is prescribed more than any other 1L treatment for ALK+ mNSCLC¹

ALECENSA achieved mPFS >2 years at primary analysis and ~3 years at exploratory follow-up analysis^2,15a

^aThe exploratory follow-up, conducted 10 months later, was assessed by investigators, and no formal treatment comparisons were performed.^4,15

While median OS was not reached at primary data cutoff, 60% of patients who started on ALECENSA are still alive at 5 years in a post-hoc analysis^4,20b

^bThis post-hoc OS analysis, conducted at ~5 years after randomization of the last patient, was exploratory in nature, and was not powered to show statistical significance.^4,20

The efficacy and safety of ALECENSA were established in the head-to-head, global, open-label, Phase 3 ALEX trial that randomized 303 first-line patients with stage IIIB/IV ALK+ mNSCLC to receive ALECENSA 600 mg orally twice daily or crizotinib 250 mg orally twice daily. Treatment in both arms continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was PFS as determined by Investigator (HR=0.48 [95% CI: 0.35, 0.66]; P<0.0001) based on RECIST v1.1. Additional efficacy endpoints included PFS (based on RECIST v1.1), ORR, DOR, and time to cause-specific CNS progression as determined by IRC. An additional secondary endpoint of ALEX was to evaluate and compare OS as determined by Investigator, and defined as the time from randomization to death from any cause.^2,3

#1 MOST PRESCRIBED 1L TREATMENT FOR ALK+ mNSCLC PATIENTS^1c

^cAccording to IQVIA Claims from January 2021-December 2022, which included 1L ALK+ mNSCLC patients identified through their first use of an ALK product.¹

CATEGORY 1, PREFERRED

NCCN

RECOMMENDATION

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommend alectinib (ALECENSA) as a first-line treatment option for ALK+ metastatic NSCLC (Category 1, Preferred)^5de

^d When an ALK rearrangement is discovered prior to first-line systemic therapy.⁵

^e NCCN makes no representations or warranties of any kind regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

1L=first-line; ALK=anaplastic lymphoma kinase; CI=confidence interval; CNS=central nervous system; DOR=duration of response; HR=hazard ratio; IRC=Independent Review Committee; mNSCLC=metastatic non-small cell lung cancer; mPFS=median progression-free survival; NCCN=National Comprehensive Cancer Network^® (NCCN^®); ORR=objective response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

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Indication

ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA-approved test.

Warnings and Precautions

Hepatotoxicity

Of 405 patients, elevations of AST >5X the upper limit of normal (ULN) occurred in 4.6% of patients, and elevations of ALT >5X the ULN occurred in 5.3% of patients. Elevations of bilirubin >3X the ULN occurred in 3.7% of patients. The majority (69% of the patients with hepatic transaminase elevations and 68% of the patients with bilirubin elevations) of these events occurred during the first 3 months of treatment. Six patients discontinued ALECENSA for Grades 3-4 AST and/or ALT elevations, and 4 patients discontinued ALECENSA for Grade 3 bilirubin elevations. Concurrent elevations in ALT or AST ≥3X the ULN and total bilirubin ≥2X the ULN, with normal alkaline phosphatase, occurred in <1% of patients treated with ALECENSA across clinical trials. Three patients with Grades 3-4 AST/ALT elevations had drug-induced liver injury (2 documented by liver biopsy)
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 3 (0.7%) patients treated with ALECENSA. One (0.2%) of these events was severe (Grade 3)
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 8% of patients. The incidence of Grade ≥3 renal impairment was 1.7%, of which 0.5% were fatal events
Dose modifications for renal impairment were required in 3.2% of patients. Median time to Grade ≥3 renal impairment was 3.7 months (range 0.5 to 14.7 months)
Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold ALECENSA for Grade 3 renal toxicity until recovery to ≤1.5X ULN, then resume at reduced dose

Bradycardia

Symptomatic bradycardia can occur with ALECENSA. Cases of bradycardia (8.6%) have been reported in patients treated with ALECENSA. Eighteen percent of 365 patients treated with ALECENSA for whom serial ECGs were available had heart rates of <50 beats per minute (bpm)
Monitor heart rate and blood pressure regularly. Dose modification is not required in cases of asymptomatic bradycardia. In cases of symptomatic bradycardia that are not life-threatening, withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If 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 case of recurrence. Permanently discontinue ALECENSA in cases of life-threatening bradycardia if no contributing concomitant medication is identified

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation

Myalgia or musculoskeletal pain occurred in 26% of patients. The incidence of Grade 3 myalgia/musculoskeletal pain was 0.7%. Dose modifications for myalgia/musculoskeletal pain were required in 0.5% of patients
Elevations of CPK occurred in 41% of 347 patients with CPK laboratory data. The incidence of Grade 3 elevations of CPK was 4.0%. Median time to Grade 3 CPK elevation was 14 days (interquartile range 13-28 days). Dose modifications for elevation of CPK occurred in 3.2% of patients
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 has been reported with ALECENSA, including cases associated with a negative direct antiglobulin test (DAT) result. 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

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to pregnant women. Administration of ALECENSA to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7X those observed in humans with ALECENSA 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 1 week following the final dose

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), edema (22%), myalgia (23%), and anemia (20%)

Use in Specific Populations

Pregnancy

Based on animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman. There are no available data on ALECENSA use in pregnant women
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

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 final dose

Females and Males of Reproductive Potential

ALECENSA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week after the final dose
Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose

Hepatic Impairment

Increased exposure of alectinib occurred in patients with severe hepatic impairment (Child-Pugh C). The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily

Patient Counseling Information

Photosensitivity

Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure while taking ALECENSA and for at least 7 days after discontinuation and to use proper protection from the sun. Advise patients to use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥50) to help protect against potential sunburn

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.

- IQVIA US Claims, January 2021-December 2022.
  
  IQVIA US Claims, January 2021-December 2022.
- ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.
  
  ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.
- Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.
  
  Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.
- Data on file. Genentech, Inc.
  
  Data on file. Genentech, Inc.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
  
  Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
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  Carnio S, Novello S, Mele T, Levra MG, Scagliotti GV. Extending survival of stage IV non-small cell lung cancer. Semin Oncol. 2014;41:69-92.
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- Silvestri GA, Gould MK, Margolis ML, et al. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl):178S-201S.
  
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  Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study [published online March 19, 2019]. J Thorac Oncol. doi:10.1016/j.jtho.2019.03.007.
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  Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(suppl):1-14.
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  Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. Abstract no. 9043. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL.
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