FAILED TRIAL: Ph 3 SKYSCRAPER-01 study of tiragolumab + Tecentriq in patients with PD-L1-high 1L mNSCLC did not reach the primary endpoint of OS
“SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000