Table 2 Secondary endpoints as per RANO-BM for intracranial lesions and as per RECIST version 1.1 for extracranial and overall lesions

From: Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial

Endpoint

RANO-BM

(intracranial lesions; n = 18)*

RECIST version 1.1

(extracranial lesions; n = 13)*

RECIST version 1.1

(overall lesions; n = 19)*

ORR;

% (95% CI); events

11.1 (1.4–34.7); 2/18

30.8 (9.1–61.4); 4/13

26.3 (9.2–51.2); 5/19

CBR;

% (95% CI); events

50.0 (26.0–74.0); 9/18

38.5 (13.9–68.4); 5/13

47.4 (24.5–71.1); 9/19

DCR;

% (95% CI); events

61.1 (35.8–82.7); 11/18

69.2 (38.6–90.9); 9/13

68.4 (43.5–87.4); 13/19

TTR; months (95% CI)

1.8 (1.6–1.9)

2.0 (1.9–2.1)

2.0 (1.7–2.1)

DoR; months (95% CI); events

NA (NA–NA); 0/1

4.8 (3.9–NA); 2/4

4.8 (4.6–NA); 3/5

PFS; months (95% CI); events

9.9 (1.6–NA); 9/20

6.8 (2.1–NA); 10/20

6.2 (3.0–NA); 12/20

  1. *Two patients did not have intracranial lesions at baseline; seven patients did not have extracranial lesions at baseline; and one patient did not have any lesions at baseline. CBR, clinical benefit rate; CI, confidence interval; DCR, disease control rate; DoR, duration of response; NA, not achieved; ORR, overall response rate; PFS, progression-free survival; RANO-BM, response assessment in neuro-oncology for brain metastases; RECIST, response evaluation criteria in solid tumors; TTR, time to response.
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