Roche's Accidental Lung Cancer Trial Data Leak: Shows Encouraging Early Data From Combination Therapy Study

Roche Holdings AG RHHBY announced that it had been made aware of inadvertent disclosure of the second interim analysis of Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).

SKYSCRAPER-01 is ongoing, and the study remains blinded to patients and investigators. Roche will continue the study until the final analysis for overall survival. 

Last year, the drug's efficacy was doubted when study data showed that tiragolumab did not slow disease progression, one of the co-primary endpoints.

All other studies in the tiragolumab program will continue as planned.

Citing Roche spokesperson Reuters noted that researchers would continue to gather trial data, with more solid survival results due to be published in Q1 of 2024.

The interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis, with median overall survival estimates of 22.9 months in the tiragolumab plus Tecentriq arm and 16.7 months in the Tecentriq monotherapy arm.

This second interim analysis occurred in February 2023 and was based on a data cut-off in November 2022, with a median follow-up of 15.5 months. 

The data showed that tiragolumab plus Tecentriq was well-tolerated, and no new safety signals were identified when adding tiragolumab to Tecentriq.

Price Action: RHHBY shares closed at $35.75 on Tuesday.