Tiragolumab Plus Atezolizumab/Chemo Fails to Enhance Survival in Metastatic Nonsquamous NSCLC
Tiragolumab (MTIG7192A) plus atezolizumab (Tecentriq) and chemotherapy didn’t enhance progression-free survival (PFS) and total survival (OS) vs pembrolizumab (Keytruda) plus chemotherapy within the first-line remedy of domestically superior, unresectable or metastatic nonsquamous non–small cell lung most cancers (NSCLC), lacking the first finish factors of the section 2/3 SKYSCRAPER-06 trial (NCT04619797).1
Within the intention-to-treat inhabitants, which consisted of sufferers handled in section 2 and three cohorts, the tiragolumab-based mixture led to lowered efficacy by way of PFS on the research’s major evaluation (HR, 1.27; 95% CI, 1.02-1.57) and OS on the first interim evaluation (HR, 1.33; 95% CI, 1.02-1.73). Notably, OS knowledge had been immature on the time of the evaluation.
Following the analyses, the research can be unblinded to sufferers and investigators, and Roche introduced that the corporate intends to cease the research. Findings can be shared with well being authorities and introduced at an upcoming medical assembly.
“These outcomes are disappointing because it was our hope that this mix would possibly yield improved outcomes for folks dwelling with metastatic nonsquamous lung most cancers,” Levi Garraway, MD, PhD, chief medical officer and head of International Product Growth at Roche, said in a information launch. “We’re grateful to the entire sufferers and healthcare professionals concerned within the research, and we are going to leverage the learnings to tell our scientific understanding of the anti-TIGIT pathway and new avenues in most cancers analysis.”
Tiragolumab is an investigational novel immune checkpoint inhibitor that options an intact Fc area and is designed to selectively bind to TIGIT. The worldwide, randomized, placebo-controlled, double-blinded SKYSCRAPER-06 research evaluated tiragolumab plus atezolizumab and chemotherapy vs pembrolizumab and chemotherapy as first-line remedy for 542 sufferers with nonsquamous NSCLC.
Sufferers had been required to be at the very least 18 years of age with histologically or cytologically documented domestically superior, unresectable or metastatic nonsquamous illness that was not eligible for healing surgical procedure and/or definitive chemoradiotherapy. Key inclusion standards included no prior systemic remedy for metastatic nonsquamous NSCLC; recognized tumor PD-L1 standing; measurable illness per RECIST 1.1 standards; a life expectancy of at the very least 12 weeks; and ample hematologic and end-organ operate.2
Sufferers had been excluded in the event that they harbored EGFR or ALK alterations; had a pulmonary lymphoepithelioma–like carcinoma subtype of NSCLC; had symptomatic, untreated, or actively progressing central nervous system metastases; had lively or a historical past of autoimmune illness or immune deficiency; or had a historical past of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or proof of lively pneumonitis.
Investigators randomly assigned sufferers in a 1:1 style to obtain 600 mg of tiragolumab plus 1200 mg of atezolizumab and chemotherapy as soon as each 3 weeks; or placebo plus 200 mg of pembrolizumab and chemotherapy as soon as each 3 weeks. The chemotherapy routine in every arm consisted of 500 mg/m2 of pemetrexed plus 75 mg/m2 of cisplatin or carboplatin at space below the curve 5 as soon as each 3 weeks.
Investigator-assessed PFS and OS served because the trial’s major finish factors throughout phases 2 and three. Total response fee (ORR) was a major finish level throughout section 2. Key secondary finish factors included OS (section 2); unbiased evaluation facility–assessed PFS (section 3); investigator-assessed PFS based mostly on PD-L1 standing (section 3); OS based mostly on PD-L1 standing; investigator-assessed ORR (section 3); period of response (phases 2 and three); and security.
Relating to security, findings for the mix of tiragolumab plus atezolizumab and chemotherapy had been in step with beforehand reported knowledge. No new or surprising security findings had been reported.1
References
- Roche gives replace on section II/III SKYSCRAPER-06 research in metastatic non-squamous non-small cell lung most cancers. Information launch. Roche. July 4, 2024. Accessed July 8, 2024. https://www.roche.com/media/releases/med-cor-2024-07-04
- A research of tiragolumab together with atezolizumab plus pemetrexed and carboplatin/cisplatin versus pembrolizumab plus pemetrexed and carboplatin/cisplatin in individuals with beforehand untreated superior non-squamous non-small cell lung most cancers (SKYSCRAPER-06). ClinicalTrials.gov. Up to date June 21, 2024. Accessed July 8, 2024. https://www.clinicaltrials.gov/research/NCT04619797
