Reassuring

Experience

Efficacy that translates into sustained 

quality of life IMPROVEMENT IN ALK+ ADVANCED NSCLC1

The duration of clinically meaningful improvement in HRQoL was longer with ALECENSA compared with crizotinib1,*,†

ALEX Phase III clinical trial: clinically meaningful improvement in HRQoL (≥10 point increase)*

ALEX Phase Ill clinical trial: 5-year OS (ITT population)

5 months
extension

in HRQOL

improvement

vs crizotinib1

5 months
extension

in HRQOL

improvement

vs crizotinib1

Favourable safety and tolerability profile with
nearly 3x longer median treatment duration2

Alex Phase Ill: overview of adverse events2

5 years
no new

safety

SIGNALS

 ALECENSA
(n=152)		Crizotinib

(n=151)
Event
Any Grade (%)
Grade 3–5 (%)
Any Grade (%)
Grade 3–5 (%)
Adverse events
97
52
97
56
Serious adverse events
3939
Adverse events leading to treatment discontinuation
1515
Adverse events leading 
to dose reduction
2020
Adverse events leading 
to dose interruption
2627

5 years
no new

safety

SIGNALS

 Alecensa
(n=152)
Event
Any Grade
(%)
Grade 3–5
(%)
Adverse events
97
52
Serious adverse events
39
Adverse events leading to treatment discontinuation
15
Adverse events leading 
to dose reduction
20
Adverse events leading 
to dose interruption
26
 Crizotinib

(n=151)
Event
Any Grade
(%)
Grade 3–5
(%)
Adverse events
97
56
Serious adverse events
39
Adverse events leading to treatment discontinuation
15
Adverse events leading 
to dose reduction
20
Adverse events leading 
to dose interruption
27

Low treatment discontinuation or dose reduction rates2,‡

THE SAFETY PROFILE OF ALECENSA IN CLINICAL PRACTICE IS

CONSISTENT WITH THAT REPORTED IN A CLINICAL TRIAL

SETTING3,§

  • The real-world demographics and disease characteristics were in line with clinical trial experience3,‡‡
  • Median treatment duration on the study was 8.3 months (arm A) and 13.8 months (arm B); most patients were still receiving ALECENSA at the data cut-off date3
  • Serious AEs in arms A and B included pneumonia (1.6% and 1.4%, respectively), dyspnoea (1.2% and 0.4%, respectively) and pleural effusion (0% and 0.8%, respectively)3
  • TRAEs occurred in 26.3% of patients, and were mostly Grade 1–2 and non-serious3

Learn more

 

ABOUT ALECENSA 


DOSING AND ADMINISTRATION >

*Changes in HRQoL and functioning were assessed using the EORTC. †1 month equal to 4.3 weeks. ‡Due to AEs. §Data cut-off: 10 May 2023.3 Patients discontinue ALECENSA due to disease progression or other reasons and go onto next line of treatment.3 **This includes an expected ALECENSA treatment period of approximately three years (observation period) and then up to a maximum of one year on the next line of treatment (post-ALECENSA follow-up period).3 ††AEs were not collected prior to enrolment for patients in arm B.3 ‡‡AEs were not collected prior to enrolment for patients in arm B.3

 

1L: first line; AE: adverse event; ALK: anaplastic lymphoma kinase; EORTC: European Organisation for Research and Treatment of Cancer; HRQoL: health-related quality of life; NSCLC: non-small cell lung cancer; OS: overall survival; PFS: progression-free survival; RECIST: Response Evaluation Criteria in Solid Tumours; SmPC: Summary of Product Characteristics; TRAE: treatment-related adverse event.

 

1. Pérol M, et al. Lung Cancer 2019;138:79–87; 2. Mok T, et al. Ann Oncol 2020;31(8):1056–1064; 3. Bria E, et al. Presented at the European Lung Cancer Congress 2024, 20–23 March, Prague, Czech Republic.