Roche Malaysia launches Alecensa, a new oral monotherapy for lung cancer

ROCHE MALAYSIA LAUNCHES ALECENSA, A NEW ORAL MONOTHERAPY FOR LUNG CANCER

FEB 27, 2019 @2.53PM

A new oral monotherapy for advanced ALK+ NSCLC. (Left to right) Dr Tho and Dr Adlinda at the official launch of Roche’s Alecensa.

Roche (Malaysia) Sdn Bhd today announced the approval of Alecensa (alectinib), a monotherapy oral treatment as a first line treatment in Malaysia, for people with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer-related deaths worldwide, and kills more people than the other three leading cancers combined (breast, prostate and colorectal)1. NSCLC is the most common type of cancer and accounts for more than 85% of lung cancers. ALK is one of the known mutations that occurs in NSCLC and is also known for its aggressive behaviour. Every year, an estimated 75,000 people are diagnosed with ALK+ NSCLC worldwide.

Data from the Malaysian Study on Cancer Survival (MySCan) recorded that lung cancer is the most “worrying” cancer among Malaysians. The average survival rate is only 11%, the lowest among patients suffering various types of cancer. It also occurs mostly in men, accounting for 69%, and in women, 31% (MySCan).

“Unlike other forms of lung cancer, ALK+ NSCLC is most commonly diagnosed in people with a light or non-smoking history. Women are also more likely to be diagnosed with this form of the disease than men and the patients also tend to be younger than most other NSCLC patients, with a median age of approximately 52,” said Dr Adlinda Alip, a Consultant Oncologist.

Alecensa
Alecensa is indicated for treatment of patients when the disease is advanced and has not been treated before or has been treated with the current standard of care. It specifically blocks the abnormal ALK protein that is responsible for the growth and spread of ALK+ NSCLC to other parts of the body and prevents the cancer from worsening.

“Drug resistance is a common occurrence for ALK+ NSCLC patients due to several reasons, including mutations in ALK. Patients develop resistance to the current standard of care (the reduction in effectiveness of a medication in treating a disease or condition), and nearly half see their tumours spread to the central nervous system (CNS) within one year of treatment. The recent clinical trials with data that point to the delay in the growth, spread and mutations of ALK+ NSCLC offers promising news to physicians and patients too,” said Dr Tho Lye Mun, a Consultant Oncologist.

A head-to-head study between Alecensa and the current standard of care (crizotinib) involving 303 people across 161 sites in 31 countries was conducted and in summary, the Phase III ALEX study showed that Alecensa, when given as initial (first-line) treatment, helped ALK+ NSCLC patients live significantly longer without their disease progressing. This is because the drug was found to effectively treat the growth of ALK+ NSCLC tumours that spread to other parts of the body including the brain and the central nervous system.

The data was recently presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting showed that Alecensa demonstrated sustained benefit in the reduction of the risk of disease progression or death by 57% after two years of follow-up in people living with ALK+ NSCLC11. The median PFS for people who received Alecensa more than tripled at 34.8 months.

Alecensa also demonstrated better efficacy where median PFS for people without CNS metastases was 34.8 months while median PFS for people with CNS metastases was 27.7 months. In terms of its safety profile, Alecensa maintained a favourable tolerability where adverse events were found to be less frequent in the arm at 44.7%. The robust data presents that the duration of response for people who received Alecensa was 33.3 months.

“Roche’s goal is to transform the standard of care with the next generation inhibitors and today’s announcement offers great news for both physicians and patients living with ALK+ NSCLC. We are really excited by the clinical studies which demonstrate Alecensa's efficacy in extending patients’ lives without their cancer worsening. It has also reduced the risk of their cancer spreading to the brain. This data certainly supports the use of Alecensa as a first line treatment for people who are newly diagnosed with this form of lung cancer and as a second line treatment for those who have not benefited from the current standard of care,” shared Lance Duan, Managing Director, Roche (Malaysia) Sdn Bhd.

Alecensa has also been included in Roche’s Patient Assistance Program which is committed to helping eligible patients access the Roche medicines they are prescribed. Under the programme, the subsidised medications will benefit the patients in supporting their overall treatment cost.

Alecensa is now approved in more than 57 countries as an initial (first-line) treatment for ALK+ advanced NSCLC, including in the United States, Europe, Japan and China.

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