Roche announced that the Phase 3 SKYSCRAPER-01 study of its investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) did not meet the co-primary endpoint of progression-free survival (PFS).
The Phase 3 trial evaluated the tiragolumab plus Tecentriq in 534 patients with first-line PD-L1-high metastatic non-small cell lung cancer (NSCLC), compared to Tecentriq alone.
In the study, patients were randomised to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity.
The initial analysis showed that the other co-primary endpoint of overall survival (OS) was immature, and a numerical improvement observed in both co-primary endpoints.
According to the study data, tiragolumab plus Tecentriq was well-tolerated, with no new safety signals identified during the use of tiragolumab.
Roche intends to continue the study until the next planned analysis, and carry out tiragolumab programme to further explore the treatment in clinical trials.
Roche global product development head and chief medical officer Levi Garraway said: “While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps.
“We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge.”
Tecentriq is a monoclonal antibody designed to inhibit PD-L1, a protein expressed on tumour cells and tumour-infiltrating immune cells, to enable the activation of T-cells.
The drug was previously approved in the US, EU and other countries worldwide, as a combination or standalone therapy for various cancer types.
Tiragolumab is an experimental novel immune checkpoint inhibitor with an intact Fc region that selectively binds to TIGIT to suppress the immune response to cancer.
The combination has previously failed to meet the coprimary endpoint in the SKYSCRAPER-02 study in patients with extensive-stage small-cell lung cancer (ES-SCLC).
Furthermore, the combination received the US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) to treat metastatic NSCLC with high PD-L1 expression.
