The two procedures relate to Pharma Mar's Zepzelca (lurbinectedin) and Amgen's Imdylltra (tarlatamab), both for the treatment of extensive-stage small cell lung cancer (ES-SCLC), for which randomised controlled trials had been conducted.
LURBINECTEDIN
Lurbinectedin in combination with atezolizumab is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide. The JCA had only one patient group and one PICO. The JCA highlights a number of uncertainties, including the fact that the study population in the RCT did not cover the entire population for the fully claimed indication.
Joint Clinical Assessment report on lurbinectedin (Zepzelca) - Public Health
TARLATAMAB
The stated indication for tarlatamab is monotherapy for the treatment of adult patients with ES-SCLC who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy. The JCA had four patient groups and seven PICOs.
Amgen submitted evidence for all PICOs. For PICOs 1, 4 and 6, the company provided a direct comparison of tarlatamab with topotecan. PICOs 3 and 5 were supported by a network meta-analysis. For PICO 2, a matching-adjusted indirect comparison (MAIC) was carried out. In PICO 7, the company provided an indirect treatment comparison for only one outcome. The reviewers found low certainty for the PICOs based on older comparators for which head-to-head data are lacking.
Joint Clinical Assessment report on tarlatamab (Imdylltra) - Public Health