Selpercatinib (1) – Retsevmo®

• Clinical trials
  • The LIBRETTO-001 basket trial is an uncontrolled clinical study with a prospective design that has been ongoing since May 2017.
  • In the Phase 1 study, which has already been completed, the maximum tolerated dose was determined. In the ongoing Phase 2 study, the determined dose was administered.

a) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with a PD-1/PD-L1 antibody as monotherapy

• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC, in whom systemic therapy is indicated following first-line treatment with a PD-1/PD-L1 antibody, is not proven.
• Selpercatinib may represent a relevant treatment option in individual cases within this therapeutic indication.

b) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with cytotoxic chemotherapy

• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, there is no evidence of additional benefit from selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC, in whom systemic therapy is indicated following first-line treatment with cytotoxic chemotherapy, is not proven.
• Selpercatinib may represent a relevant treatment option in individual cases within the indicated therapeutic indication.

c) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential treatment with a PD-1/PD-L1 antibody and platinum-based chemotherapy

• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, there is no additional benefit of selpercatinib as monotherapy in adult patients with RET-fusion-positive advanced NSCLC, for whom systemic therapy is indicated following first-line 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, is not proven.
• Selpercatinib may represent a relevant treatment option in individual cases within this therapeutic indication.

Courtesy translation only, please refer to the German original.