Table 1 MORPHEUS-CRC Treatment Efficacy.

From: Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer

 

Atezolizumab + isatuximab

Regorafenib

 

(n = 15)

(n = 13)

Confirmed ORR, No. (%)

0 (0.0)

0 (0.0)

% [95% CI]a

[0, 21.8]

[0, 24.7]

SD, No. (%)

3 (20.0)

8 (61.5)

% [95% CI]b

[4.3, 48.1]

[31.6, 86.1]

PD, No. (%)

10 (66.7)

3 (23.1)

% [95% CI]b,c

[38.4, 88.2]

[5.0, 53.8]

DCR, No. (%)

2 (13.3)

2 (15.4)

% [95% CI]d

[1.7, 40.0]

[1.9, 45.5]

PFS, median survival (months, 95% CI)a

1.4 (1.4–1.8)

2.8 (1.6–3.1)

OS, median survival (months, 95% CI)a

5.1 (3.1–7.8)

10.2 (4.8-NE)

  1. Clinical cutoff: 3 March 2020. No. number of patients, DCR disease control rate, NE not estimable, ORR objective response rate, OS overall survival, PD progressive disease, PFS progression-free survival, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease, CI confidence interval.
  2. aPer INV RECIST 1.1.
  3. bPatients were classified as achieving stable disease or progressive disease if assessment was at least 6 weeks from randomization.
  4. cOne patient treated with atezolizumab + isatuximab beyond progression had prolonged disease stabilization.
  5. dCriteria for disease control is either response and/or stable disease for at least 12 weeks.
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