Roche Announces Phase III SKYSCRAPER-01 Trial Failure of PD-L1 + TIGIT Combination in First-Line NSCLC

▎Armstrong

On November 26, 2024, Roche announced that the Phase III clinical trial SKYSCRAPER-01 of PD-L1 antibody + TIGIT antibody combination therapy for locally recurrent or metastatic non-small cell lung cancer did not meet the primary endpoint of OS in the final analysis.

In July this year, Roche updated the latest adjustments to its R&D pipeline in the interim financial report for the first half of the year, which included the termination of four Phase III clinical trials. These comprised two Phase III clinical trials of the TIGIT antibody Tiragolumab for the treatment of NSCLC: one being the first-line treatment of NSCLC with PD-L1+TIGIT+chemotherapy, and the other being adjuvant treatment with PD-L1+TIGIT following surgery for NSCLC.

At that time, Roche's TIGIT antibody had only five Phase III clinical trials ongoing: two focused on NSCLC, two on esophageal cancer, and one on liver cancer.

The remaining two Phase III clinical trials around NSCLC, SKYSCRAPER-01 is for PD-L1+TIGIT first-line treatment of PD-L1 high-expression NSCLC.In 2022, it was announced that the study did not meet the primary endpoint of PFS, and this time it was announced that the OS endpoint was not met.SKYSCRAPER-03: First-line treatment with PD-L1+TIGIT for Stage III inoperable NSCLC completed enrollment in Q2 2023.

Summary

Roche stated that it will continue to evaluate the study to determine whether adjustments to the ongoing research are necessary. ThroughoutTIGIT Antibody Track: Clinical Exploration Faces Repeated Setbacks, but Several Companies with TIGIT Antibody Layouts Continue Clinical Exploration; Roche, Merck, BeiGene, Gilead, and GlaxoSmithKline Are All in Phase III Clinical Trials.