Triplet regimen works against triple-negative breast cancer

Treatment with a novel combination of famitinib, camrelizumab, and nab-paclitaxel appears safe and effective in patients with advanced immunomodulatory triple-negative breast cancer (TNBC), as shown in the results of the phase II FUTURE-C-Plus trial.

The open-label, single-arm FUTURE-C-Plus included 48 patients with previously untreated, advanced, immunomodulatory TNBC (CD8 antibody immunohistochemistry staining ≥10 percent). All patients were given 20 mg of oral famitinib on days 1 to 28; 200 mg of intravenous (IV) camrelizumab on days 1 and 15; and IV nab-paclitaxel 100 mg/m² on days 1, 8, and 15 in 4-week cycles.

After a median follow-up of 17.0 months, the primary endpoint of objective response rate (ORR; assessed per Response Evaluation Criteria in Solid Tumours 1.1) was 81.3 percent (95 percent confidence interval [CI], 70.2–92.3). Five patients achieved complete response, while 34 had partial responses.

With respect to key secondary endpoints, median progression-free survival was 13.6 months (95 percent CI, 8.4–18.8), while median duration of response was 14.9 months (95 percent CI, not estimable [NE]–NE). Median overall survival (OR) was not reached.

There were no treatment-related deaths recorded during the trial. Among 30 patients with IHC, 13 (43.3 percent) were programmed death-ligand 1 (PD-L1)–negative. Of note, PD-L1 correlated with a favourable response with the triplet regimen. PKD1 and KAT6A somatic mutations were associated with treatment response. KAT6A was positively associated with OR (p=0.044), whereas BRCA1 (p=0.055) and PKD1 (p=0.034) showed the reverse.

The findings underscore the potential of the triplet combination as a potential first-line treatment option for advanced immunomodulatory TNBC.