EU green light for Takeda’s Alunbrig

The decision allows use of the once-daily drug in adults with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) who have previously been treated with Pfizer’s Xalkori (crizotinib).

Clearance was based on data from the global Phase II ALTA trial, in which patients were randomised to receive one of two dosing regimens of Alunbrig (brigatinib): 90mg once daily or the recommended dosing regimen of 180mg once daily with seven-day lead-in at 90mg once daily.

Of the patients who received the recommended dosing regimen 56% achieved an objective response rate (ORR), while the median duration of response (DOR) was 15.7 months, according to the firm.

Also, the drug demonstrated a median progression-free survival (PFS) of 16.7 months and overall survival of 34.1 months for this patient population.

"The introduction of targeted therapies has greatly improved the treatment of ALK+ NSCLC, yet for the approximately 70 percent of patients who progress on crizotinib with brain metastases, additional therapeutic options are needed," said Enriqueta Felip, head of the Thoracic Oncology Unit, Oncology Department at Vall d’Hebron University Hospital in Barcelona. "Alunbrig showed sustained systemic and intracranial efficacy results and a manageable safety profile, leading to the longest progression-free survival and overall survival reported in this setting."

"This is the first time a median progression-free survival of over 16 months as assessed by an independent review committee and median overall survival of 34 months have been reported in the post-crizotinib setting, which highlights the strength of the ALTA trial data," added Jesús Gómez-Navarro, head of Oncology Clinical Research and Development at Takeda.

However, access to the drug in the UK remains uncertain, given that the National Institute for Health and Care Excellence has turned down NHS funding for it in draft guidelines.

The Institute concluded that clinical evidence based on single-arm studies suggests that people having Alunbrig live longer than those having the standard of care after Xalkori, Novartis’ Zykadia (ceritinib), and that they live longer before their condition worsens.

However, the company’s results from its cost-effectiveness modelling "are optimistic" and its assumption about the length of treatment benefit of the drug "is clinically implausible", it said.

Also, the most plausible cost-effectiveness estimates for Alunbrig compared with ceritinib are more than £50,000 per QALY, and thus above what the Institute normally considers acceptable for an end-of-life treatment, and so it could not be recommended for routine use on the NHS.

Alunbrig was approved in the US in May 2017.

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