Clinical activity
tumor, death, Tumor, endometrial adenocarcinoma, PD, embolic stroke, bintrafusp
TUMOR, ORAL MUCOSITIS, TUMOR, METASTATIC ADENOCARCINOMA, ENDOMETRIAL ADENOCARCINOMA, BEST, EMBOLIC STROKE, EVENTS
Tumor response according to investigator assessment by RECIST v1.1 was evaluated in 19 of the 20 treated patients in the study (Supplementary Table Tumor Burden Change for Sum of Target Lesions Diameters (mm): Best Relative Change from Baseline (%). The best relative change from baseline (%) in tumor burden for the sum of target lesion diameters (mm) is shown for the 3 mg (red bars) and 5 mg (blue bars) dose cohorts, respectively. Sixteen patients were evaluable; 1 patient from the 3 mg dose cohort and 2 patients from the 5 mg dose cohort did not have post-baseline tumor scans before death. Notes: Data are presented for all patients with at least 1 post-baseline tumor measurement. Dashed lines indicate cutoff for PR (-30%) and PD (+ 20%). The label of x-axis tick is a combination of the best overall response of patient and the primary malignancy site. The 5 mg dose cohort is composed of 7 patients enrolled in the dose escalation cohort at the 5 mg dose and 6 patients enrolled in the dose expansion Cohort A. Of 2 patients with a confirmed PR, the first patient was a 64-year-old white male with metastatic adenocarcinoma of rectal origin who had received prior anticancer treatment with oxaliplatin, fluorouracil, bevacizumab, irinotecan, folinic acid, bintrafusp alfa, an investigational drug, and radiation. He was started on the 3 mg dose with a PR after C4 (confirmed after C6). His fruquintinib dose was increased to the RP2D of 5 mg during C13 given the observed benefit at the discretion of the investigator, and with sponsor approval the patient received fruquintinib for another 18 cycles. During this extended treatment period, SD was maintained, and a dose reduction to 4 mg occurred due to oral mucositis in C28. He discontinued study drug at C31 due to PD (i.e., 28.6 months after the first study drug administration). His DoR was 7.6 months The second patient was a 69-year-old white female with endometrial adenocarcinoma who received prior treatment with paclitaxel, carboplatin, docetaxel, and radiation. She received fruquintinib 5 mg for 8 cycles. She discontinued study drug due to an embolic stroke that the investigator attributed to fruquintinib in C8. She demonstrated a PR after C4 (confirmed after C6 and C7), and her response was ongoing when she started gemcitabine treatment 3.7 months after the first assessment of PR.Median follow up was 18.0 months (range: 0.6–28.7) in the 3 mg cohort and 11.1 months (range: 1.9–26.2) in the 5 mg dose cohort. In the 3 mg dose cohort, 6 (85.7%) patients had PFS events, and the median PFS was 6.90 months (95% CI: 0.56, not estimable) (Supplementary Fig. 