Ad Hoc Announcement Pursuant to Art. 53 Lr Roche Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-stage Small Cell Lung Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq^® (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. 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. Data will be presented at an upcoming medical meeting.

“Today’s outcome is disappointing as we had hoped to continue building on the advances of Tecentriq in extensive stage small-cell lung cancer, which remains difficult to treat. We are thankful to all the patients and healthcare professionals involved in the study,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We look forward to seeing additional data from the upcoming phase III trial in PD-L1-high non-small cell lung cancer based on the encouraging results from the CITYSCAPE study.”

SCLC is the most aggressive form of any lung cancer and is characterised by rapid progression and poor survival.^1,2 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.³ More options are needed, particularly for hard-to-treat cancers like SCLC, and Roche is committed to exploring innovative medicines to improve outcomes for people with lung cancer.

The tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need. 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.^4,6 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 (SKYSCRAPER-01, SKYSCRAPER-03), ES- SCLC (SKYSCRAPER-02), oesophageal cancers (SKYSCRAPER-07, SKYSCRAPER-08), and multiple early trials in various tumour types.⁵