A CONSISTENT AND TOLERABLE

SAFETY PROFILE¹

MOST ADVERSE EVENTS in ALINA WERE MILD-TO-MODERATE (Grades 1–2)¹

ALINA: Adverse events occurring in ≥15% of patients²

ALINA: Adverse events occurring in ≥10% of patients in either trial group¹

Adverse event, n (%)^1,*  Safety evaluable cohort	ALECENSA (n=128)		Chemotherapy (n=120)
	Any Grade	Grade 3 or 4	Any Grade	Grade 3 or 4
Any adverse event	126 (98.4)	38 (29.7)	112 (93.3)	37 (30.08)
Nausea	10 (7.8)	0	87 (72.5)	5 (4.2)
Creatine kinase increased	55 (43.0)	8 (6.2)	1 (0.8)	1 (0.8)
Constipation	54 (42.2)	1 (0.8)	30 (25.0)	1 (0.8)
Aspartate aminotransferase increased	53 (41.4)	1 (0.8)	6 (5.0)	0
Alanine aminotransferase increased	43 (33.6)	2 (1.6)	11 (9.2)	0
Blood bilirubin increased	43 (33.6)	2 (1.6)	1 (0.8)	0
Decreased appetite	7 (5.5)	0	35 (29.2)	1 (0.8)
COVID-19	37 (28.9)	0	1 (0.8)	0
Myalgia	36 (28.1)	1 (0.8)	2 (1.7)	0
Anaemia	30 (23.4)	0	31 (25.8)	1 (0.8)
Vomiting	9 (7.0)	0	30 (25.0)	2 (1.7)
Alkaline phosphatase increased	32 (25.0)	0	4 (3.3)	0
White blood cell count decreased	2 (1.6)	0	23 (19.2)	4 (3.3)
Neutrophil count decreased	3 (2.3)	0	21 (17.5)	12 (10.0)
Asthenia	14 (10.9)	0	19 (15.8)	3 (2.5)
Neutropenia	2 (1.6)	0	19 (15.8)	10 (8.3)
Creatinine increased	19 (14.8)	1 (0.8)	6 (5.0)	0
Cough	19 (14.8)	1 (0.8)	4 (3.3)	0
Fatigue	18 (14.1)	1 (0.8)	16 (13.3)	2 (1.7)
Rash	18 (14.1)	1 (0.8)	7 (5.8)	0
Malaise	6 (4.7)	0	16 (13.3)	0
Weight increased	17 (13.3)	1 (0.8)	1 (0.8)	0
Diarrhoea	16 (12.5)	1 (0.8)	10 (8.3)	1 (0.8)
Headache	14 (10.9)	0	8 (6.7)	0
Dyspnoea	13 (10.2)	1 (0.8)	3 (2.5)	0
Dysgeusia	13 (10.2)	0	3 (2.5)	0
Oedema, peripheral	13 (10.2)	0	1 (0.8)	0

*Adverse event, n (%)1, Safety evaluable cohort**	ALECENSA (n=128)
	Any Grade	Grade 3 or 4
Any adverse event	126 (98.4)	38 (29.7)
Nausea	10 (7.8)	0
Creatine kinase increased	55 (43.0)	8 (6.2)
Constipation	54 (42.2)	1 (0.8)
Aspartate aminotransferase increased	53 (41.4)	1 (0.8)
Alanine aminotransferase increased	43 (33.6)	2 (1.6)
Blood bilirubin increased	43 (33.6)	2 (1.6)
Decreased appetite	7 (5.5)	0
COVID-19	37 (28.9)	0
Myalgia	36 (28.1)	1 (0.8)
Anaemia	30 (23.4)	0
Vomiting	9 (7.0)	0
Alkaline phosphatase increased	32 (25.0)	0
White blood cell count decreased	2 (1.6)	0
Neutrophil count decreased	3 (2.3)	0
Asthenia	14 (10.9)	0
Neutropenia	2 (1.6)	0
Creatinine increased	19 (14.8)	1 (0.8)
Cough	19 (14.8)	1 (0.8)
Fatigue	18 (14.1)	1 (0.8)
Rash	18 (14.1)	1 (0.8)
Malaise	6 (4.7)	0
Weight increased	17 (13.3)	1 (0.8)
Diarrhoea	16 (12.5)	1 (0.8)
Headache	14 (10.9)	0
Dyspnoea	13 (10.2)	1 (0.8)
Dysgeusia	13 (10.2)	0
Oedema, peripheral	13 (10.2)	0

*Adverse event, n (%)1, Safety evaluable cohort**	Chemotherapy (n=120)
	Any Grade	Grade 3 or 4
Any adverse event	112 (93.3)	37 (30.08)
Nausea	87 (72.5)	5 (4.2)
Creatine kinase increased	1 (0.8)	1 (0.8)
Constipation	30 (25.0)	1 (0.8)
Aspartate aminotransferase increased	6 (5.0)	0
Alanine aminotransferase increased	11 (9.2)	0
Blood bilirubin increased	1 (0.8)	0
Decreased appetite	35 (29.2)	1 (0.8)
COVID-19	1 (0.8)	0
Myalgia	2 (1.7)	0
Anaemia	31 (25.8)	1 (0.8)
Vomiting	30 (25.0)	2 (1.7)
Alkaline phosphatase increased	4 (3.3)	0
White blood cell count decreased	23 (19.2)	4 (3.3)
Neutrophil count decreased	21 (17.5)	12 (10.0)
Asthenia	19 (15.8)	3 (2.5)
Neutropenia	19 (15.8)	10 (8.3)
Creatinine increased	6 (5.0)	0
Cough	4 (3.3)	0
Fatigue	16 (13.3)	2 (1.7)
Rash	7 (5.8)	0
Malaise	16 (13.3)	0
Weight increased	1 (0.8)	0
Diarrhoea	10 (8.3)	1 (0.8)
Headache	8 (6.7)	0
Dyspnoea	3 (2.5)	0
Dysgeusia	3 (2.5)	0
Oedema, peripheral	1 (0.8)	0

No unexpected safety findings were observed; no Grade 5 (fatal) adverse events were reported¹
Median treatment duration was 23.9 months for ALECENSA and 2.1 months for chemotherapy¹

The safety profile of ALECENSA in resected ALK+ NSCLC was consistent with the established ALECENSA safety profile^1,3–5

Treatment withdrawal due to adverse events occurred in 5.5% of patients on ALECENSA vs 12.5% of patients on chemotherapy¹

*The safety-evaluable population included patients who underwent randomisation and received any amount of ALECENSA or platinum-based chemotherapy. AEs are listed according to Medical Dictionary for Regulatory Activities preferred term.1 Multiple occurrences of the same AE in an individual patient are counted only once.1

AE: adverse event; ALK: anaplastic lymphoma kinase; COVID-19: coronavirus disease 2019; NSCLC: non-small cell lung cancer; SmPC: Summary of Product Characteristics.

1. Wu Y-L, et al. N Engl J Med 2024;390(14):1265–1276; 2. Solomon BJ, et al. Presented at the European Society for Medical Oncology Congress, 20–24 October 2023, Madrid, Spain; 3. Hida T, et al. Lancet 2017;390(10089):29–39; 4. Peters S, et al. N Engl J Med 2017;377(9):829–838; 5. Zhou C, et al. Lancet Respir Med 2019;7(5):437–446.

M-XX-00018707; Date of preparation: August 2024
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A CONSISTENT AND TOLERABLE

SAFETY PROFILE¹

MOST ADVERSE EVENTS in ALINA WERE MILD-TO-MODERATE (Grades 1–2)¹

ALINA: Adverse events occurring in ≥15% of patients²

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FOR HEALTHCARE PROFESSIONALS

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A CONSISTENT AND TOLERABLE

SAFETY PROFILE1

MOST ADVERSE EVENTS in ALINA WERE MILD-TO-MODERATE (Grades 1–2)1

ALINA: Adverse events occurring in ≥15% of patients2

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Explore

SAFETY PROFILE¹

MOST ADVERSE EVENTS in ALINA WERE MILD-TO-MODERATE (Grades 1–2)¹

ALINA: Adverse events occurring in ≥15% of patients²