OncoPrism-NSCLC Test Predicts Key Clinical Outcomes in Lung Cancer

OncoPrism-NSCLC was found to be a predictive biomarker of immune checkpoint inhibitor benefit vs a general prognostic tool in patients with NSCLC.

Results from the observational PREDAPT trial (NCT04510129) supported the utility of the OncoPrism-non–small cell lung cancer (NSCLC) test, a clinical tool to identify which patients with late-stage NSCLC are most likely to benefit from immune checkpoint inhibitor (ICI) therapy, according to a press release from the developer, Cofactor Genomics.1 A preprint of these results was published on MedRxiv.2

Among 195 patients with stage IIIB or IV NSCLC who were treated with an anti–PD-L1 ICI after 1 or 2 prior chemotherapy regimens in the phase 3 OAK trial (NCT02008227), those with a high OncoPrism measurement had a median progression-free survival (PFS) of 4.7 months, which was higher than the median PFS in both the OncoPrism medium and low groups, which were 2.8 months and 1.5 months, respectively (P <.001). Similarly, the median OS was 20.4 months in the OncoPrism high group, 10.5 months in the OncoPrism medium group, and 12.7 months in the OncoPrism low group (P = .043).

In the PD-1 inhibitor group, which included 89 samples and data generated from the PREDAPT trial, the overall response rate (ORR) trended upwards from the low to medium to high OncoPrism groups (P = .0083), with respective ORRs of 36%, 36%, and 71%. The median PFS was 7.0 months, 5.5 months, and 18.6 months in the OncoPrism low, medium, and high groups, respectively (P = .0038). The median OS was 13.0 months, 9.2 months, and 22.9 months, respectively (P = .011).

The performance of OncoPrism-NSCLC was compared with the performance of PD-L1 in PREDAPT, and results from the eligible 83 patients were utilized. The OncoPrism-NSCLC test achieved numerically higher accuracy, sensitivity, specificity, positive predictive power, and negative predictive power vs PD-L1 tumor proportion score (TPS). Notably, there was a significant association between OncoPrism group and response (P = .008), and there was a significant but modest association between OncoPrism-NSCLC and PD-L1 TPS (P = .006). PD-L1 TPS was associated with treatment type, as more monotherapy was observed among patients with a TPS of 50 or higher (P <.001). OncoPrism groups were also associated with disease histology, as those in the high group had fewer squamous cancers (P = .028).

Additionally, an analysis was run to evaluate OncoPrism in patients who were not treated with an ICI. OncoPrism did not predict PFS or OS in patients treated with docetaxel (n = 193), nor was it predictive of OS in the Cancer Genome Atlas (TCGA) Program data set, which was composed of 1010 patients treated with a variety of non-ICI therapies.

“For more than a decade, clinicians have lacked a reliable test that predicts which [patients with] lung cancer will benefit from immunotherapy—leaving physicians and patients to make high-stakes decisions with limited information,” stated Jarret Glasscock, PhD, chief technology officer of Cofactor Genomics and senior author on the publication, in the press release.1 “This study, drawing on nearly 1500 [patient with] NSCLC samples from 4 independent cohorts, finally delivers what the field has been asking for: a powerful immunotherapy predictive diagnostic, rather than a prognostic marker with limited clinical utility. OncoPrism-NSCLC brings precision medicine to immunotherapy.”

Four datasets were included in the study. The first included patients in the TCGA dataset, which was filtered for primary tumor samples (n = 1010); the second included patients from the OAK trial who were treated with docetaxel (n = 193); the third included patients treated with atezolizumab (Tecentriq) in the OAK trial (n = 195); and the fourth included samples from the anti–PD-1 PREDAPT ICI cohort (n = 89).

Eligible patients in the trial had stage IV NSCLC at diagnosis, receipt of at least 2 doses of anti–PD-1 immunotherapy as first-line single-agent treatment or in combination with chemotherapy, and an ECOG performance status of 0 to 2 prior to initiation of anti–PD-1 therapy.

In the press release, the investigators noted that these results provide a “clinically actionable alternative to PD-L1 TPS” to oncologists treating patients with NSCLC.

References

1. Cofactor Genomics advances predictive cancer diagnostics with landmark OncoPrism-NSCLC study. News release. Cofactor Genomics. December 17, 2025. Accessed December 19, 2025. https://tinyurl.com/jj8bvwbn
2. Flanagan KC, Earls J, Hiken J, et al. Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study. MedRxiv. Published online on December 15, 2025. doi:10.64898/2025.12.12.25342169