Ceritinib (3) – Zykadia®

• Clinical trials
  • The ASCEND-4 trial is the registration trial for ceritinib in this therapeutic indication. It is the only randomised, actively controlled, open-label trial (RCT) with ceritinib in this therapeutic indication.
  • The ASCEND-4 trial enrolled previously untreated adult patients with ALK-positive NSCLC at a locally advanced or metastatic stage (stage IIIB or IV). Patients received either treatment with ceritinib or with platinum-based combination chemotherapy comprising cisplatin in combination with pemetrexed or carboplatin in combination with pemetrexed.
  • With regard to crizotinib in comparison with this bridging comparator, the pharmaceutical manufacturer identifies the two studies PROFILE 1014 and PROFILE 1029.
  • These studies were all randomised, actively controlled, open-label trials. The studies included previously untreated adult patients with ALK-positive NSCLC at a locally advanced or metastatic stage.

a) Adult patients for first-line treatment of advanced, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC)

• For first-line treatment of patients with advanced, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), an additional benefit over the appropriate comparator therapy is not proven.
• In the absence of available RCTs, the pharmaceutical manufacturer identified three studies relevant to an indirect comparison of ceritinib and crizotinib.
• The studies identified by the pharmaceutical manufacturer – ASCEND-4, PROFILE 1014 and PROFILE 1029, identified by the pharmaceutical company, are not suitable for an indirect comparison due to the lack of comparability of the bridging comparator, and therefore cannot be used to draw conclusions regarding the additional benefit of ceritinib compared with the appropriate comparator therapy.
• As there are no relevant data available overall for assessing the additional benefit of ceritinib, the additional benefit is not proven.
• Overall assessment / Conclusion
  • Due to differences in the bridging comparator, the studies ASCEND-4, PROFILE 1014 and PROFILE 1029 identified by the pharmaceutical manufacturer are not suitable for an indirect comparison.
  • As there are no relevant data available overall to assess the additional benefit of ceritinib, the additional benefit is not proven.

Courtesy translation only, please refer to the German original.