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Roche trial of NSCLC treatment fails to meet primary endpoints

Posted on by angelo

The overall safety profile of treatment in patients with NSCLC was consistent with those previously reported. Credit: crystal light / Shutterstock.

Roche announced that its Phase II/III SKYSCRAPER-06 clinical trial of tiragolumab in combination with Tecentriq (atezolizumab) and chemotherapy as first-line treatment for non-squamous non-small cell lung cancer (NSCLC) did not meet primary endpoints.

The international, placebo-controlled, randomized, double-blind trial enrolled 542 previously untreated patients with locally advanced unresectable or metastatic non-squamous NSCLC.

It evaluated tiragolumab plus Tecentriq and chemotherapy versus pembrolizumab and chemotherapy.

Overall survival (OS) and progression-free survival (PFS) were the primary endpoints of the trial.

According to the results, the trial failed to meet the primary endpoints of PFS and OS at the primary and interim analyses, respectively.

Additionally, the Tecentriq regimen was shown to reduce PFS and OS efficacy compared to the comparator group in the intention-to-treat population.

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The overall safety profile of treatment was consistent with those previously reported, with no new or unexpected findings detected.

Based on these data, the company will unblind patients and researchers from the trial, which will be discontinued.

Investigators will be updated on the latest developments and the results are expected to be shared with health agencies.

Various other ongoing Phase III studies are evaluating treatment parameters and indications distinct from the SKYSCRAPER-06 trial.

The Company plans to evaluate necessary changes to the ongoing tiragolumab program.

Levi Garraway, head of global product development and chief medical officer at Roche, said: “These results are disappointing as we had hoped that this combination might produce better outcomes for people with metastatic non-squamous lung cancer.

“We are grateful to all the patients and healthcare professionals involved in the study, and we will use the lessons learned to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”

Last month, the company released results from the Phase III STARGLO trial, in which Columvi treatment significantly extended survival in patients with relapsed or refractory diffuse large B-cell lymphoma.