Selpercatinib (4) – Retsevmo®

• Clinical trials
  • The LIBRETTO-001 basket trial is an uncontrolled clinical study with a prospective design that has been ongoing since May 2017.
  • Cohort 2, which is relevant to the present therapeutic indication, included patients with advanced or metastatic solid tumours with RET fusion who had not previously received standard therapy.

a) Adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% of tumour cells; first-line treatment

• Pembrolizumab was identified as the appropriate comparator therapy.
• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adults with RET-fusion-positive advanced NSCLC with PD-L1 expression ≥ 50% of tumour cells in first-line treatment is not proven.
• Overall assessment
  • The results of the single-arm LIBRETTO-001 study alone are not suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
  • Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC in the first-line setting is not proven.

b) Adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% of tumour cells; first-line treatment

• The appropriate comparator therapy comprises platinum-based (cisplatin/carboplatin) chemotherapy, which may also be combined with an immune checkpoint inhibitor (pembrolizumab), with or without pemetrexed, paclitaxel or nab-paclitaxel.
• For adults with an ECOG performance status of 2, monochemotherapy may also be considered as an alternative.
• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adults with RET-fusion-positive advanced NSCLC with PD-L1 expression in < 50% of tumour cells in first-line treatment is not proven.
• Overall assessment
  • The results of the single-arm LIBRETTO-001 study presented here are not, on their own, suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
  • Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC in the first-line setting is not proven.

Courtesy translation only, please refer to the German original.