On October 20, 2023 Foundation Medicine Inc. and Roche reported that they will present the results from a randomized, global precision oncology study designed to prospectively assess the efficacy and safety of molecularly-guided therapy for patients with unfavorable subset cancer of unknown primary (CUP) (Press release, Foundation Medicine, OCT 20, 2023, View Source [SID1234636198]). The results will be presented as a late breaking abstract on Saturday, October 21 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Madrid, Spain.
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People with CUP typically have a group of heterogeneous tumors. These patients have a high unmet medical need due to the lack of a definitive diagnosis of a primary tumor site. Because the cancer’s tumor of origin is unknown, targeted treatment has historically been challenging. As a result, there has been little progress in improving the poor outcomes for patients with CUP. The CUPISCO study investigated how comprehensive genomic profiling (CGP), using Foundation Medicine’s U.S. Food and Drug Administration (FDA)-approved and CE-marked FoundationOneCDx and FoundationOneLiquid CDx diagnostic tests, could impact progression-free and overall survival in patients with CUP.
"Patients with CUP do not have many treatment options, so we set out to investigate how implementing comprehensive genomic profiling could impact outcomes," said Dr. Jeffrey Ross, Medical Director at Foundation Medicine. "The increases we saw in progression-free survival are promising, and we look forward to conducting continued research to reinforce the value of genomic profiling for patients with CUP."
The global multicenter CUPISCO trial spanned 159 sites in 34 countries and included over 400 patients with CUP who were not amenable to resection and/or radiation with curative intent. During induction therapy, patients received three cycles of standard platinum-based chemotherapy. Patients achieving disease control were randomized 3:1 to targeted therapy informed by comprehensive genomic profiling versus chemotherapy continuation for at least three further cycles. The median progression-free survival in the patients who received molecularly guided therapy was 6.1 months (95% confidence interval [CI] 4.7–6.5) versus 4.4 months (4.1–5.6) for chemotherapy (hazard ratio [HR] 0.72; 95% CI 0.56–0.92; p=0.0079). The median overall survival was 14.7 months (95% CI 13.3–17.3) versus 11.0 months (9.7–15.4), respectively (HR 0.82; 95% CI 0.62–1.09; p=0.1779), though overall survival data were immature at cutoff.
"Collaborative research is core to our work at Foundation Medicine and is a pivotal element of making continued progress for cancer patients," said Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. "Our high-quality tests played an important role in demonstrating the value of molecularly guided therapy for this patient population and we hope that these findings will lead to increased treatment options for their care."