Real-world clinical outcomes of trifluridine-tipiracil monotherapy (FTD-TPI) and FTD-TPI + bevacizumab combination therapy (FTD-TPI+bev) in 639 black patients (pts) with metastatic colorectal cancer (mCRC).

81 Background: In the phase 3 SUNLIGHT trial, FTD-TPI+bev improved overall survival (OS) as compared to FTD-TPI in treatment-refractory mCRC. Out of 492 pts in the study, only 7 (1.4%) pts self-identified as Black; therefore, the potential benefit of FTD-TPI+bev in this pt population was not well-examined. We present the largest analysis to date of real-world clinical outcomes of FTD-TPI and FTD-TPI+bev in Black pts with mCRC. Methods: We retrospectively identified Black adult pts with a documented exposure to FTD-TPI and diagnosis of mCRC at or prior to the initiation of FTD-TPI using United States-based electronic medical records and claims in the ConcertAI RWD360 dataset. Pts were categorized as having received FTD-TPI or FTD-TPI+bev. Kaplan-Meier analyses were used to compare the real-world overall survival (rwOS) and time to discontinuation (rwTTD) from the date of first exposure to FTD-TPI (index). Multivariate Cox regression analyses were used to control for pt characteristics including demographics, ECOG performance status (PS), comorbidities, metastatic sites, time from mCRC diagnosis to index, lab results, and prior receipt of regorafenib. Results: Out of 639 Black pts included in our study, 551 received FTD-TPI and 88 received FTD-TPI+bev. Index years were 2021-2023 for 26% and 92% pts receiving FTD-TPI and FTD-TPI+bev, respectively. Pts receiving FTD-TPI had median age 61 years; male 51.2%; any comorbidities 43.9%; ECOG PS 0-1 36.7%; median time from mCRC diagnosis to index 632 days. Pts receiving FTD-TPI+bev had median age 59 years; male 50.0%; any comorbidities 42.0%; ECOG PS 0-1 60.3 %; median time from mCRC diagnosis to index 579.5 days. The rwOS was significantly improved with FTD-TPI+bev as compared with FTD-TPI (10.8 vs 6.2 months, respectively; p=0.0001), similar to the SUNLIGHT study (Table). In the adjusted model, pts who received FTD-TPI+bev had a significantly lower risk of death as compared to pts who received FTD-TPI (hazard ratio [HR]=0.45; p<0.0001). The rwTTD was also significantly prolonged with FTD-TPI+bev as compared with FTD-TPI (3.8 vs 2.4 months, respectively; p<0.0001). In the adjusted model, pts who received FTD-TPI+bev had about half the risk of discontinuation as compared with pts who received FTD-TPI (HR=0.51; p<0.0001). Conclusions: This is the first study to compare the clinical outcomes with FTD-TPI vs. FTD-TPI+bev in Black pts with mCRC in the real-world setting. Our study confirmed OS improvement with FTD-TPI+bev as compared to FTD-TPI in Black pts with mCRC, as seen in the overall population of the SUNLIGHT trial. Current Study SUNLIGHT Black n rwOS months (95% CI) Black n OS months (95% CI) FTD-TPI 551 6.2 (5.7-6.9) 3 7.5 (6.3-8.6) FTD-TPI+bev 88 10.8 (7.8-16.0) 4 10.8 (9.4-11.8) HR 0.45 (95% CI 0.33-0.63; p<0.0001) HR 0.61 (95% CI 0.49-0.77; p<0.001)