Mirati's SAPPHIRE trial in NSCLC terminated, results posted on ClinicalTrials.gov

The sitravatinib-nivolumab combination missed its goal against docetaxel, with overall survival data posted for the terminated phase 3 study.

The SAPPHIRE study, a phase 3 trial comparing sitravatinib plus nivolumab against docetaxel in advanced non-squamous non-small cell lung cancer, was stopped early. The registry lists the overall status as terminated, with the reason given as inability to meet protocol objectives.¹ The lead sponsor is Mirati Therapeutics Inc., with Bristol-Myers Squibb as a collaborator.

The study had started on 2019-07-15, reached primary completion on 2023-03-20, and completion on 2025-09-30.¹ Results were first posted to the registry on 2024-06-25, and the record was last updated on 2026-09-30, according to the listing.

In the trial design, enrollment reached 577 participants.¹ Patients received either sitravatinib combined with nivolumab or docetaxel, in patients with advanced non-squamous NSCLC who had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.¹

Because the study completion date listed is later than the date results were first posted, it is not clear from the registry whether this posted dataset represents the complete, final analysis of the trial.

Fact check notes

ImpreciseMedian overall survival was 12.22 months for nivolumab+sitravatinib vs 10.58 months for docetaxelSource lists OS values but does not explicitly label them as 'median'; the entry adds this characterization without confirmation.
ImpreciseBecause study completion date is later than results posting date, it's unclear if posted dataset is final analysisThis is a reasonable inference from the dates but is not explicitly stated in the source; treated as interpretive speculation rather than a direct fact.
Checker's noteThe entry characterizes the OS figures as 'median' values, a specific statistical descriptor not explicitly stated in the source data.
Checker's noteThe closing statement about data completeness is an inference not directly supported by source text, though it follows logically from the listed dates.
Sentence removedFor the primary endpoint of overall survival, the posted data show a median of 12.22 months in the nivolumab and sitravatinib arm compared with 10.58 months for docetaxel, with a log-rank analysis p=0.144.a figure with no citation
Sentence removedSerious adverse events were reported in 128 of 281 patients on the combination arm and 102 of 273 patients on docetaxel, per the posted results.a figure with no citation

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.