Roche announced that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI:1.02, 1.73], which was immature. The combination of tiragolumab plusecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumib plus Tecentriq and chemotherapy, and no new or unexpected findings were identified.

Based on these results, patients and investigators will be unblinded and intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting. Ongoing phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER -06.

Based on today's results, the company will evaluate any relevant changes needed to the ongoing tiragolumab programme. SKYSCRAPER the06 is a global phase II/III, randomised, placebo-controlled and double-blinded study evaluating tiragolumabplus Tecentriq®® (atezolIZumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumib and chemotherapy in 542 people with non-squamous non- small cell lung cancer. Primary endpoints are overall survival (OS) and progression-free survival (P FS).

TIGIT is an investigational novel immune checkpoint inhibitor with an intact Fc region. TIGIT selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq® ("atezolizumab).

The TIGIT pathway is distinct but complementary to thePD-L1/PD-1 pathway. Dual blockade with tiragolumab and chemotherapy may help overcome immune suppression and restore the immune response. Tecentriq (atezolizumib) is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer.

TIGIT was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer.