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Roche cheers latest data from phase 3 'Alecensa' study

By Josh White

Date: Friday 29 May 2020

Roche cheers latest data from phase 3 'Alecensa' study

(Sharecast News) - Roche presented updated data from the pivotal phase 3 'ALEX' study on Friday, showing an increased five-year survival rate with 'Alecensa', or alectinib, compared with crizotinib, in people living with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).
The Swiss drugmaker said the data confirmed the longer-term efficacy of Alecensa, already demonstrated across three phase 3 clinical trials.

It said the updated results from the ALEX study showed a five-year survival rate of 62.5% in the Alecensa treatment group, compared to 45.5% with crizotinib.

Despite longer median treatment duration, the safety profile of Alecensa remained favourable and consistent with previous data, with no new safety signals identified.

The company said the overall survival data, which was not yet mature, showed a benefit in patients with CNS metastases at baseline of a 42% reduction in the risk of death compared to crizotinib, as well as in those without central nervous system (CNS) metastases at baseline of a 24% reduction in the risk of death versus crizotinib.

Roche said that data followed on from the final, mature progression-free survival data from the ALEX study, presented at the European Society for Medical Oncology congress in September, which demonstrated a reduced risk of disease worsening or death by 57% with Alecensa, versus crizotinib, in ALK-positive NSCLC.

The updated data confirmed the superior efficacy and tolerability of Alecensa in comparison to crizotinib, it said.

About 85% of lung cancer cases were NSCLC and, of those patients, about 5% were ALK-positive.

ALK-positive NSCLC is caused by a gene fusion or rearrangement that overactivates the ALK protein, driving cancer cell growth and survival.

The disease often affects those who least expect it, with 50% of patients younger than 50 and around 70% never having smoked.

"These data further support Alecensa as the standard of care for people with metastatic ALK-positive NSCLC," said chief medical officer and head of global product development Levi Garraway.

"Importantly, these data show clinically meaningful benefit in people with or without central nervous system metastases.

"These data, and our work in lung cancer more broadly, demonstrate our continued commitment to improving outcomes for people with this disease."


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