Pralsetinib (1) – Gavreto®

• Clinical trials
  • To demonstrate the additional benefit of pralsetinib in the treatment of adults with Rearranged-during-Transfection (RET)-fusion-positive, advanced non-small cell lung cancer (NSCLC) who have not previously been treated with a RET inhibitor, the pharmaceutical manufacturer has submitted the results of the ARROW trial.
  • ARROW is an ongoing, international, multicentre, single-arm, open-label Phase I/II trial.
  • The IMpower132 trial is an international, multicentre, open-label Phase III trial in which adult patients with non-squamous cell NSCLC at stage IV and with an ECOG performance status of 0 or 1, who have not previously received any treatment for their metastatic disease.

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

• The additional benefit is not proven.
• The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The comparison presented is not suitable for drawing conclusions regarding additional benefit.
• Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.

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

• An additional benefit is not proven.
• The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The comparison presented is not suitable for drawing conclusions regarding additional benefit.
• Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.

c) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) following first-line treatment with a PD-1/PD-L1 antibody as monotherapy

• An additional benefit is not proven.
• The results of the submitted single-arm ARROW trial alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The comparison presented is not suitable for drawing conclusions regarding additional benefit.
• Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.

d) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) following first-line treatment with cytotoxic chemotherapy

• The additional benefit is not proven.
• The results of the single-arm ARROW study submitted are not, on their own, suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The comparison presented is not suitable for drawing conclusions regarding additional benefit.
• Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.

e) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC); 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

• An additional benefit is not proven.
• The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The comparison presented is not suitable for drawing conclusions regarding additional benefit.
• Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.