Roche: Phase III SKYSCRAPER-02 Study In ES-SCLC Fails To Meet Co-primary Endpoint

Swiss drug major Roche Holding AG (RHHBY) announced Wednesday that the phase III SKYSCRAPER-02 study in extensive-stage small cell lung cancer or ES-SCLC did not meet its co-primary endpoint of progression-free survival.

The trial evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial or first-line treatment for people with ES-SCLC.

The company noted that the co-primary endpoint of overall survival was not met at its interim analysis and is unlikely to reach statistical significance at the planned final analysis. Data suggest tiragolumab plus Tecentriq and chemotherapy was well-tolerated and no new safety signals were identified when adding tiragolumab.

The company will present the trial data at an upcoming medical meeting.

ES-SCLC is a hard-to-treat disease and Tecentriq plus chemotherapy remains a standard of care. Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC (phase III IMpower133 study), and was the first approved treatment option in 20 years.

Tiragolumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in 2021 for the initial treatment of PD-L1-high metastatic non-small cell lung cancer, based on the results of the phase II CITYSCAPE study – representing the only investigational anti-TIGIT therapy to be granted this designation.

The phase III SKYSCRAPER-01 trial is currently ongoing to confirm the CITYSCAPE results.

Since 2020, Roche has initiated five phase III trials, including NSCLC, ES- SCLC, oesophageal cancers, and multiple early trials in various tumour types.

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