Trastuzumab deruxtecan (5) – Enhertu®

• Clinical trials
  • The DESTINY-Lung02 trial is an ongoing, randomised, two-arm, double-blind, multicentre Phase II trial investigating the efficacy and safety of two different doses of trastuzumab deruxtecan (6.4 mg/kg vs. 5.4 mg/kg, once every three weeks) in adults with metastatic HER2-mutated NSCLC.

a) Adults with advanced non-small cell lung cancer (NSCLC) whose tumours harbour an activating HER2 (ERBB2) mutation, following prior treatment with platinum-based chemotherapy without immunotherapy

• An additional benefit is not proven.
• In the absence of direct comparative studies of trastuzumab deruxtecan against the appropriate comparator therapy, the pharmaceutical manufacturer cites the randomised, uncontrolled clinical study DESTINY-Lung02 as evidence of additional benefit.
• Due to its single-arm design, the DESTINY-Lung02 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of trastuzumab deruxtecan compared with the appropriate comparator therapy.

b) Adults with advanced non-small cell lung cancer (NSCLC) whose tumours harbour an activating HER2 (ERBB2) mutation, following prior treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential therapy with a PD-1/PD-L1 antibody and platinum-based chemotherapy

• The additional benefit is not proven.
• In the absence of direct comparative studies of trastuzumab deruxtecan against the appropriate comparator therapy, the pharmaceutical manufacturer cites the randomised, uncontrolled clinical study DESTINY-Lung02 as evidence of additional benefit.
• The data submitted are not suitable for a comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.