SKYSCRAPER-06: tiragolumab combo vs pembrolizumab comboPrimary endpoint, investigator-assessed PFS, full analysis set (n=542). Deaths also higher in the tiragolumab arm (54.3% vs 42.9%). Posted results, ClinicalTrials.gov NCT04619797.
Posted results for Roche’s Phase II/III SKYSCRAPER-06 trial mark one of the harder failures for the investigational anti-TIGIT class. In previously untreated advanced non-squamous non-small-cell lung cancer, the experimental antibody tiragolumab — added to atezolizumab (Tecentriq) and platinum chemotherapy — did not merely fail to beat the standard of care. It performed measurably worse than pembrolizumab (Keytruda) plus the same chemotherapy backbone, and more patients in the tiragolumab arm died. Tiragolumab is not an approved treatment; it is an experimental agent being tested in this trial.
The randomized, double-blind trial (NCT04619797) enrolled 542 patients, randomized 1:1 to tiragolumab plus atezolizumab plus pemetrexed (Alimta) and carboplatin or cisplatin (269 patients) versus placebo plus pembrolizumab plus the same chemotherapy (273 patients). Eligibility was restricted to non-squamous NSCLC and excluded tumors with EGFR mutations or ALK fusions, as well as ROS1 or BRAF V600E alterations, so the result speaks to a specific lung-cancer subtype, not lung cancer broadly. Both primary endpoints were analyzed in the full analysis set of all randomized patients, not a PD-L1-selected subgroup.
A head-to-head trial that adds an antibody to first-line lung-cancer treatment did not beat the regimen it was meant to improve — and the safety signal deserves attention.
The investigational B-cell-modulating antibody cut the flare rate by more than half without depleting B cells — but it is not approved for any use, and a company-reported U.S. filing, unconfirmed by the FDA, only begins regulatory review.
Dr. Lena Fischer, Research & Preprints Desk · 2 min
Public HealthCDC alerts US clinicians to person-to-person Andes hantavirus cluster aboard Antarctic cruiseA federal Health Alert flagged eight cases and three deaths tied to a Southern Atlantic expedition cruise — a count since revised up to 13 by the ECDC, with no new deaths — and warns that Andes virus is the only hantavirus documented to spread person-to-person, though rarely and typically only with close, prolonged contact.
Digital Health & AIArtera sells a metastatic prostate-cancer mortality estimate on a validation it has not disclosedThe company says ArteraAI Prostate gauges 5-year prostate cancer-specific mortality in ADT-plus-ARPI-treated metastatic disease, citing a validation it does not name, size, or quantify — while the one peer-reviewed validation measured overall survival in a docetaxel trial with no ARPI arm.