Roche’s Alecensa reduces the risk of disease recurrence or death by more than 60% in Asian patients with ALK-positive early-stage non-small cell lung cancer

• ALINA is the first and only Phase III study to show an improvement in disease-free survival in patients from Asia with early-stage resected ALK-positive non-small cell lung cancer (NSCLC)

• With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy, 1 more effective treatment options are urgently needed to provide the best chance for cure 2

• Data are being presented as a late-breaking abstract during the ESMO Asia 2023 Presidential Symposium

Singapore, 02 December 2023 - Roche announced today results from the Phase III ALINA study demonstrating a clinically meaningful improvement in disease-free survival (DFS; primary endpoint) in patients from Asia. This exploratory subanalysis of 140 patients from South Korea, mainland China, Japan, Taiwan, and Thailand confirmed the global ALINA data and showed that Alecensa® (alectinib) reduces the risk of disease recurrence or death by 61% (hazard ratio [HR]=0.39; 95% CI: 0.18-0.85) compared with platinum-based chemotherapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).3 A clinically meaningful improvement of central nervous system (CNS)-DFS was also observed (HR=0.24; 95% CI: 0.05-1.12).3 The safety and tolerability of Alecensa in this analysis were consistent with the global ALINA data and previous trials in the metastatic setting and no unexpected safety findings were observed.3 Overall survival data in the Asia subgroup were immature at the time of this analysis.3

The results of this Asia subanalysis from the ALINA study are being presented as a late-breaking abstract at the European Society of Medical Oncology (ESMO) Asia Congress 2023 Presidential Symposium on Saturday 02 December 2023.

“About half of patients with early-stage NSCLC experience disease recurrence. By reducing the risk of recurrence or death of ALK-positive early-stage NSCLC by such a significant amount, Alecensa can potentially alter the course of this disease as we aim to provide the best chance for cure,” said Ying Ying Yeoh, General Manager of Roche Pharmaceuticals, Singapore. “We urgently need to do more to help people with lung cancer, as it is one of the leading causes of cancer mortality in Singapore.4 We hope to work closely with local authorities to bring Alecensa to patients in Singapore, in this early setting as soon as possible.”

“Alecensa represents a potentially important new treatment option for all patients, including those from Asia, with ALK-positive resected lung cancer,” said Professor Jin Seok Ahn, Medical Oncologist, Samsung Medical Center, Republic of Korea. “In a setting where treatment options are currently extremely limited, the magnitude of the disease-free survival benefit observed in the Asia subgroup of this study has the potential to change the way we manage the disease for people from this region.”

In Singapore, around 1,500 people are diagnosed with NSCLC each year,4-5 approximately 5% of whom have ALK-positive disease.6-8 Delaying disease progression is of particular importance for people with ALK-positive NSCLC, who are generally younger – usually around 55 – and are at higher risk of developing brain metastases than those with other types of NSCLC.9 Once the disease returns it often spreads to other parts of the body, at which point it is usually considered incurable.2,10 Comprehensive biomarker testing not only in the metastatic stage but also in the early stages is essential to helping physicians secure a complete, personalised diagnosis and identify the right treatment for each patient.

Results from the exploratory subanalysis of ALINA were consistent with results from the primary analysis of the study, recently presented at the ESMO Congress 2023, where consistent DFS results were seen across all subgroups, including disease stage and race (Asian and non-Asian patients).11 Overall, use of Alecensa in the adjuvant setting was tolerable, manageable and in line with its known safety profile in the metastatic setting.1,11

The ALINA studyis a Phase III, randomised, active-controlled, multicentre, open-label study evaluating the efficacy and safety of adjuvant Alecensa® (alectinib) compared with platinum-based chemotherapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study includes 257 patients who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, Kamakura Research Laboratories for people with non-small cell lung cancer (NSCLC) whose tumours are identified as anaplastic lymphoma kinase (ALK) positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China. In Singapore, Alecensa is indicated for the first-line treatment of patients with ALK-positive locally advanced or metastatic NSCLC and for the treatment of patients with ALK-positive, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib.12

Lung cancer is one of the leading causes of cancer death globally.13 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.13 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85% of all cases.14 Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.1 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.2

Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease. Roche is committed to improving treatment of early-stage lung cancers to help increase the chance of cure for more people.

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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References

1. Pignon JP et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.

2. Hendricks LE et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339-357.

3. Ahn JS et al. Efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy (CT) in patients (pts) from Asia with resected, early-stage ALK+ non-small cell lung cancer (NSCLC): a subanalysis of ALINA. Presentation at: European Society for Medical Oncology Asia Congress; 1-3 December 2023. Late-breaking abstract #LBA1.

4. Singapore Health Promotion Board, National Registry of Diseases Office: Singapore Cancer Registry Annual Report 2021.  [Internet; cited November 2023] Available from:

5. SingHealth: Lung Cancer - What It Is.  [Internet; cited November 2023] Available from:

6. Barlesi et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016; 387(10026):1415-1426.

7. Tian et al. Clinical characteristics and sequence complexity of anaplastic lymphoma kinase gene fusions in Chinese lung cancer patients. Lung Cancer. 2017;114:90-95.

8. Cancer.Net®. Lung Cancer - Non-Small Cell: Statistics. [Internet; cited November 2023]. Available from:  

9. Griesinger F et al. Brain metastases in ALK-positive NSCLC – time to adjust current treatment algorithms. Oncotarget. 2018:9(80);35181-35194.

10. Peters S et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer. NEJM. 2017;377:829-838.

11. Solomon B et al. ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Presentation at: European Society for Medical Oncology Congress; 20-24 October 2023. Late-breaking abstract #LBA2.

12. ALECENSA Prescribing information. Singapore. Current at January 2022. 

13. Thandra KC et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52.

14. American Cancer Society: What Is Lung Cancer? [Internet; cited November 2023] Available from: 
    

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