Biodesix, Boulder, Colo, has recently presented new data demonstrating that the company’s VeriStrat test is predictive of outcomes for patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors in the frontline setting, even when adjusted for PD-L1 status.1,2
The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood, serum, or plasma of patients with NSCLC. Test results assign a good or poor classification to patient samples. Multiple studies support the observation that patients with a good result have a better prognosis than patients with a poor result, independent of current clinical prognostic indicators and treatment choice. VeriStrat testing has been validated in more than 70 studies with more than 6,600 patients, and is covered by Medicare and most private health insurers.
The presented data were part of an interim analysis from a prospectively designed observational study, which is currently enrolling NSCLC patients at 33 sites in the United States and will follow patient outcomes for 18 months. The preplanned interim analysis was conducted with the first 1,000 patients enrolled with at least a 12-month follow-up.
Results for the subset of patients with advanced NSCLC treated with frontline immune checkpoint inhibitors, with or without chemotherapy (n = 85; all frontline therapies n = 419), suggest that incorporating the host immune response as part of the initial patient assessment provides clinically meaningful information when choosing a frontline therapy for NSCLC.
Immune checkpoint inhibitors have emerged as standard treatment for wild-type patients with NSCLC based on established superiority of efficacy over chemotherapy. However, it is known that not all patients testing positive for PD-L1 respond to immune checkpoint inhibitors.
“Additional studies are needed to establish the clinical utility of biomarker testing when choosing appropriate treatment regimens,” explains Patricia Rich, MD, medical oncologist and medical director for thoracic oncology at Cancer Treatment Centers of America. “Real-world data from this large registry observational study suggests that the overall survival for patients receiving a frontline immune checkpoint inhibitor added to chemotherapy, or alone, may not be significantly different from platinum-based chemotherapy. This is potentially good news for patients that are not eligible for immune checkpoint inhibitor therapy, cannot tolerate it, or simply cannot afford it.”
When patients were stratified by the VeriStrat blood-based host response proteomic test, the individuals identified as VeriStrat poor (~25%) had significantly lower overall survival with any immune checkpoint inhibitor-based regimen, as compared to individuals identified as VeriStrat good (~75%), even when adjusted for PD-L1 status in a multivariate analysis. Highlights of the interim analysis included:
- The VeriStrat test is predictive of outcomes for all treatment regimens and lines of therapy, including immunotherapy, even when adjusted for PD-L1 status.
- Patients with a VeriStrat good result had significantly higher median overall survival compared to VeriStrat poor patients on both immunomonotherapy and immunotherapy in combination with chemotherapy.
- Patients with a VeriStrat poor result did not benefit from treatment with immunotherapy or the addition of immunotherapy to platinum-based therapy.
“Immunotherapy has improved outcomes for many advanced-stage patients with NSCLC but is not beneficial for everyone,” says Linda Traylor, PhD, vice president for clinical development and medical affairs at Biodesix. “There is a clinical need for a test to predict outcomes, including overall survival and response, that helps guide physicians and patients to the right treatment strategy in order to save critical time, reduce unnecessary side effects, and minimize treatment cost for ineffective therapies.
“These data add to the already extensive and growing body of evidence supporting the VeriStrat test results as predictive of outcomes across treatment choices, now including immune checkpoint inhibitors,” says Traylor. “Biodesix is focused on supporting research that identifies effective therapies to treat the aggressive VeriStrat poor disease state.”
For further information, visit Biodesix.
- Rich P, Roder J, Dubay J, et al. Real-world performance of blood-based proteomic profiling in immunotherapy treatment in advanced stage NSCLC [abstract LBA1, online]. Poster presented at the 2019 Multidisciplinary Thoracic Cancers Symposium, San Diego, March 14–16, 2019. Int J Radiat Oncol Biol Phys. In press. Available at: www.thoracicsymposium.org/thoracicsymposium/media/thoracicsymposium/2019/pdfs/thoracicabstracts.pdf. Accessed April 4, 2019.
- Rich (Thompson) P, Roder J, Dubay J, et al. Real-world performance of blood-based proteomic profiling in immunotherapy treatment in advanced stage NSCLC [poster, online]. Poster presented at the 2019 Multidisciplinary Thoracic Cancers Symposium, San Diego, March 14–16, 2019. Available at: www.biodesix.com/wp-content/uploads/2019/03/insight-interim-astro-poster.pdf. Accessed April 4, 2019.