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Alecensa for patients with previously treated ALK-positive non-small cell lung cancer, CHMP positive opinion


The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the use of Alecensa ( Alectinib ) for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer ( NSCLC ) whose disease has progressed following treatment with Crizotinib ( Xalkori ).

ALK-positive NSCLC occurs in approximately 5% of people with advanced NSCLC, translating to about 75,000 people globally being diagnosed with the disease per year.
ALK-positive disease is more common in light or non-smokers.

Most people living with ALK-positive NSCLC develop resistance to the current standard of care, and nearly half see their tumours spread to the central nervous system within one year of treatment.

The EMA’s recommendation is based primarily on data from the pivotal studies NP28673 and NP28761. The studies showed that Alecensa shrank tumours in people with advanced ALK-positive NSCLC whose disease had progressed following treatment with Crizotinib, overall response rate; ORR: 50.8%, ( 95% CI: 41.6%, 59.9% ) and 52.2% ( 95% CI 39.7%, 64.6% ) in NP28673 and NP28761, respectively.
Alectinib extended the time that people lived without their disease worsening or death ( progression-free survival, PFS ) by 8.9 months, [ 5.6, 12.8 ] in the NP28673 study and 8.2 months, [ 6.3, 12.6 ] in the NP28761 study.

In a pooled analysis of Central Nervous System ( CNS ) endpoints from studies NP28673 and NP28761 Alectinib shrank CNS tumours that were measurable in 64.0% of people [ 95% CI: 49.2%, 77.1% ].
In addition, the people whose CNS tumours shrank in response to Alectinib continued to respond for a median of 11.1 months, CNS duration of response ( DOR ) [ 95% CI: 7.6, NE ].
Twenty two percent ( n=11 ) of people achieved a complete response of their measurable CNS tumours.

Alecensa as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase ( ALK ) positive advanced non-small cell lung cancer ( NSCLC ) previously treated with Crizotinib.

In addition, Alecensa is being explored as a first-line treatment option with the phase III ALEX and J-ALEX studies comparing Alecensa to Crizotinib, the current standard of care.
Results from the J-ALEX study were presented at the 2016 American Society of Clinical Oncology ( ASCO ) Annual Meeting and showed that Alectinib reduced the risk of disease worsening or death ( progression-free survival by 66% ( hazard ratio [ HR ]=0.34, 99% CI: 0.17-0.70, p less than 0.0001 ) compared to Crizotinib in this specific form of lung cancer.

NP28673 study

NP28673 is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alectinib in 138 people with ALK-positive NSCLC whose disease progressed on Crizotinib.
The study showed by assessment of an independent review committee ( IRC ) an ORR of 50.8% ( 95% CI: 41.6%, 60.0% ), as measured by RECIST criteria.
An investigator assessment also showed tumours shrank in 51.4% of people who received Alectinib.
In addition, the people whose tumours shrank in response to Alectinib continued to respond for a median of 15.2 months ( 95% CI: 11.2, 24.9 ) ( duration of response; DOR ).
The median progression-free survival for people who received Alectinib was 8.9 months ( 95% CI: 5.6, 12.8 ).
Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common ( occurring in at least 2% of people ) grade 3 or higher adverse event was shortness of breath ( dyspnoea; 4% ).

NP28761 study

NP28761 is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alectinib in 87 people with ALK-positive NSCLC whose disease progressed on Crizotinib.
The study showed by assessment of an independent review committee ( IRC ) an ORR of 52.2% ( 95% CI: 39.7%, 64.6% ) as measured by RECIST criteria.
An investigator assessment showed tumours shrank in 52.9% of people who received Alectinib ( 95% CI: 41.9%, 63.7% ).
In addition, the people whose tumours shrank in response to Alectinib continued to respond for a median of 14.9 months ( 95% CI: 6.9, NE ) ( DOR ).
The median progression-free survival for people who received Alectinib was 8.2 months ( 95% CI: 6.3, 12.6 ).
Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common ( occurring in at least 2% of people ) grade 3 or higher adverse events were an increase in muscle enzymes ( increased blood levels of creatine phosphokinase; 8% ), increased liver enzymes ( alanine aminotransferase; 6%, and aspartate aminotransferase; 5% ) and shortness of breath ( dyspnoea; 3% ), elevated levels of triglyceride ( hypertriglyceridaemia ), increased potassium level ( hypokalaemia ) and low levels of phosphate in the blood ( hypophosphatemia; 3% ). Partial blood thickening ( thromboplastin; 2% ) time prolonged. ( Xagena )

Source: Roche, 2016

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