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NICE issues final decision on brigatinib after crizotinib for NSCLC

NICE has approved brigatinib for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib.

There are no studies or clinical trials directly comparing brigatinib with ceritinib. Hence, the decision is based on clinical evidence from 2 single-arm studies: the phase II ALTA study (n=110 in the treatment arm) and Study‑101, a phase I and II study including 25 people in the relevant subgroup.

The median follow-up in ALTA was 24.3 months and median overall survival was 34.1 months. Objective response rate was 56% in ALTA and 76% in Study‑101. Median progression-free survival was 16 months in ALTA and Study‑101. Median duration of response was 14 months in ALTA and 26 months in Study‑101. Of the ALTA cohort, 74% had previously had chemotherapy and 67% had brain metastases at baseline.

Data from the ASCEND‑2 and ASCEND‑5 trials was used for indirect comparison with ceritinib. ASCEND‑2 was a single-arm phase II study including 140 people. ASCEND‑5 was a randomised controlled phase III trial including 231 people in the ceritinib arm.

Meta-analysis of the data suggested brigatinib improved overall survival by 16-19 months and improved progression-free survival by 9-10 months compared with ceritinib.

Because of uncertainty regarding long-term effects with brigatinib, cost-effectiveness estimates are uncertain. The most plausible estimates for brigatinib compared with ceritinib are around the higher end of what NICE normally considers acceptable for an end-of-life treatment. However, the population eligible for brigatinib is small and will decrease because crizotinib is no longer considered first-line treatment for ALK-positive NSCLC. Future treatments will be limited for those who have crizotinib.

Taking these exceptional circumstances into account, NICE recommends brigatinib for ALK-positive advanced NSCLC in adults who have had crizotinib.


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