Roche’s phase II/III SKYSCRAPER-06 study of tiragolumab plus Tecentriq & chemotherapy in metastatic non-squamous NSCLC fails to meet primary endpoints
Overview
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.
Combo of Tiragolumab Plus Tecentriq
- The combination of tiragolumab plus Tecentriq 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 tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified.
- Based on these results, patients and investigators will be unblinded and we 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.
From the CMO: Roche
- These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development.
- We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.
Phase III studies
- Ongoing phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER-06.
- Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab programme.
SKYSCRAPER-06
- SKYSCRAPER-06 is a global phase II/III, randomised, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non- small cell lung cancer.
- Primary endpoints are overall survival (OS) and progression-free survival (PFS).
About Tiragolumab
- Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region.
- Tiragolumab 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 the PD-L1/PD-1 pathway.
- Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.
Tecentriq Approvals
- Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer.
- Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).
- Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).
About Tecentriq
- Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
- By inhibiting PD-L1, Tecentriq may enable the activation of T-cells.
- Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers.
In addition to intravenous infusion, Tecentriq has been approved as a subcutaneous formulation in over 40 countries. The approved indications for Tecentriq SC mirror those of Tecentriq IV.
