Roche has reported that its Phase II/III SKYSCRAPER-06 clinical trial of tiragolumab along with Tecentriq (atezolizumab) and chemotherapy as first-line treatment for non-squamous non-small cell lung cancer (NSCLC) failed to meet primary endpoints.
The international, placebo-controlled, randomised, double-blinded trial enrolled 542 priorly untreated patients with locally advanced unresectable or metastatic non-squamous NSCLC.
It assessed tiragolumab plus Tecentriq and chemotherapy as against pembrolizumab and chemotherapy.
Overall survival (OS) and progression-free survival (PFS) were the trial's primary endpoints.
According to the findings, the trial failed to meet the primary endpoints of PFS and OS at primary and first interim analyses, respectively.
Furthermore, the Tecentriq regimen was demonstrated to reduce PFS and OS efficacy versus the comparator arm in the intent-to-treat population.
The treatment’s overall safety profile was in line with those reported previously without any new or unexpected findings detected.
Based on this data, the company will unblind the patients and investigators in the trial, which will be halted.
Investigators will be alerted on the latest developments, with the results anticipated to be shared with health agencies.
Various other Phase III studies underway are assessing treatment settings and indications distinct from the SKYSCRAPER-06 trial.
The company plans to assess any needed changes to the ongoing tiragolumab programme.
Roche Global Product Development head and chief medical officer Levi Garraway said: “These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer.
“We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”
Last month, the company reported findings from the Phase III STARGLO trial where the Columvi regimen significantly extended survival in patients with relapsed or refractory diffuse large B-cell lymphoma.
