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)*

5 months
extension
in HRQOL
improvement
vs crizotinib1
ALEX Phase Ill clinical trial: 5-year OS (ITT population)

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
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 |
39 | 39 | ||
Adverse events leading to treatment discontinuation |
15 | 15 | ||
Adverse events leading
to dose reduction |
20 | 20 | ||
Adverse events leading
to dose interruption |
26 | 27 |
No filter results
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 |
No filter results
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 |
No filter results
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

- 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
*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.