ALECENSA (alectinib)

ALECENSA as monotherapy is indicated as adjuvant treatment for adult patients with Stage IB to IIIA* ALK+ NSCLC following complete tumour resection.

ALECENSA as monotherapy is indicated for the first-line treatment of adult patients with ALK+ advanced NSCLC.¹

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Prescribing information

ALECENSA in ALK+ resected early-stage NSCLC

Watch Dr Tom Newsom-Davis as he describes the ALINA study and what adjuvant ALECENSA being available in the UK could mean for eligible patients.

Hear from our expert panel as they share their thoughts on how to identify, diagnose, and manage patients with ALK+ resectable early-stage NSCLC.

Explore the ALINA trial

ALINA (NCT03456076) is a global, Phase III, open-label, randomised clinical trial assessing the efficacy and safety of adjuvant ALECENSA compared with platinum-based chemotherapy in patients with completely resected stage IB (tumour ⩾4 cm) to IIIA (UICC/AJCC 7th edition) ALK+ NSCLC.

Baseline characteristics were overall well balanced between the ALECENSA and chemotherapy treatment arms, except for sex (female: 58% vs 47%, respectively) and smoking history (never smoked: 65% vs 55%, respectively).^¶,4

ALECENSA significantly reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy (HR=0.24 [95% CI: 0.13, 0.43]).⁴

Adapted from Wu Y-L, et al.⁴
This data is from the primary analysis. Clinical cut-off date: June 2023.

Primary endpoint: At the time of primary DFS analysis, in the ITT population^§, median DFS was not reached (95% CI: NE, NE) for ALECENSA and was 41.3 months (95% CI: 28.5, NE) for chemotherapy (HR=0.24 [95% CI: 0.13, 0.43], p<0.001)⁴
The median duration of follow-up for survival was 27.8 months for ALECENSA and 28.4 months for chemotherapy⁴
Subgroup analysis: ALECENSA provided consistent DFS benefit across Stage IB through to Stage IIIA, at the time of primary DFS analysis⁴
Secondary endpoint: At the data cut-off date, OS data were immature with only 2.3% OS events (deaths) reported (two events in the ALECENSA arm, four events in the chemotherapy arm)⁴

This data should be interpreted with caution.

ALECENSA provided a 78% reduction in risk of CNS recurrence or death compared with platinum-based chemotherapy (HR=0.22 [95% CI: 0.08, 0.58])⁴

Data from exploratory endpoints are descriptive and no confirmatory clinical conclusions can be drawn.

Patients with ALK+ NSCLC are at high risk for brain metastases, which are associated with poor prognosis and have a severe impact on health-related quality of life^4–6

Adapted from Wu Y-L, et al.⁴

This data is from the primary analysis. Clinical cut-off date: June 2023.

In the ALINA study, fewer patients had recurrence in the brain in the ALECENSA arm (3.1%) compared with the chemotherapy arm (11%), consistent with data in ALK+ advanced-stage NSCLC^1,4

The safety profile of ALECENSA in ALK+ resected early-stage NSCLC was consistent with the established ALECENSA safety profile^1,4,7–10

Most adverse events in ALINA were mild-to-moderate (Grades 1–2). No Grade 5 adverse events were reported^#,4
All serious adverse events that were considered to be related to treatment with ALECENSA were resolved⁴
The most commonly reported adverse events were increased creatine kinase levels (43.0%) and constipation (42.2%) in the ALECENSA group, and nausea (72.5%) and decreased appetite (29.2%) in the chemotherapy group⁴

For full prescribing and safety information please refer to ALECENSA summary of product characteristics.

To contact Roche, use: medinfo@roche.com.

^*Stage IB (tumours ≥4 cm), II or IIIA NSCLC classified according to the 7th edition of the UICC/AJCC.⁴

^†Cisplatin + pemetrexed, cisplatin + vinorelbine, or cisplatin + gemcitabine; cisplatin could be switched to carboplatin in case of intolerability.

^‡DFS defined as the time from randomisation to the first documented recurrence of disease or new primary NSCLC as determined by the investigator, or death of any cause.⁴

^§Defined as the time from randomisation to the first documented recurrence of disease in the CNS, or death by any cause; this endpoint was exploratory.⁴

^¶Clinical cut-off date: June 2023.

^#The safety-evaluable population included 128 patients who received ALECENSA and 120 patients who received chemotherapy. The median duration of treatment for the safety-evaluable population was 23.9 months with ALECENSA and 2.1 months with chemotherapy. Multiple occurrences of the same adverse event in an individual patient are counted only once.

Abbreviations

AE, adverse event; ALK+, anaplastic lymphoma kinase positive; BID, twice a day; CI, confidence interval; CNS, central nervous system; CNS-DFS, central nervous system disease-free survival; DFS, disease-free survival; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; ITT, intent-to-treat; NE, not evaluable; NICE, National Institute for Health and Care Excellence; NSCLC, non-small cell lung cancer; OS, overall survival; Q3W, once every three weeks; TRAE, treatment-related adverse event; UICC/AJCC, Union for International Cancer Control/American Joint Committee on Cancer.

References

Roche. ALECENSA (alectinib) Summary of Product Characteristics. 2024.
European Medicines Agency. Alecensa EU Risk Management Plan 2024. Available at: https://www.ema.europa.eu/en/documents/rmp/alecensa-epar-risk-management-plan_en.pdf. Accessed: January 2025.
National Institute for Health and Care Excellence. Alectinib for resected ALK-positive non-small cell lung cancer [TA1014]. Available at: https://www.nice.org.uk/guidance/TA1014. Accessed: January 2025.
Wu Y-L, et al. N Engl J Med 2024;390(14):1265–1276.
Roy Castle Lung Cancer Foundation. "Brain Metastases" Roy Castle Lung Cancer Foundation. Available at: https://roycastle.org/about-lung-cancer/advanced-lung-cancer/brain-metastases. Accessed: January 2025.
Guérin A, et al. J Med Econ 2015;18(4):312–322.
Solomon BJ, et al. Presented at the European Society for Medical Oncology Congress, 20–24 October 2023, Madrid, Spain.
Hida T, et al. Lancet 2017;390(10098):29–39.
Peters S, et al. N Engl J Med 2017;377(90):829–838.
Zhou C, et al. Lancet Respir Med 2019: 2019;7(5):437–446.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. You can also report via the free Yellow Card app available from the Apple App Store or Google Play Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.

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