Table 4 Summary of clinical efficacy in evaluable analysis set

From: First-in-human phase Ia study of the PI3Kα inhibitor CYH33 in patients with solid tumors

Clinical efficacya

DL1–4 CYH33, 1–20 mg QD n = 10

DL5 CYH33, 30 mg QD n = 9

DL6 CYH33, 40 mg QD n = 19

All patients CYH33, 1–60 mg QD n = 42

CR, n (%)

0

0

1 (5.3)

1 (2.4)

PR, n (%)

1 (10.0)

1 (11.1)

2 (10.5)

4 (9.5)

SD, n (%)

2 (20.0)

6 (66.7)

9 (47.4)

18 (42.9)

Confirmed ORRb, n (%)[95% CI]

1 (10.0)

1 (11.1)

3 (15.8)

5 (11.9)

[0.25, 44.5]

[0.28, 48.25]

[3.38, 39.58]

[3.98, 25.63]

DCR (CR + PR + SDc), n (%)

3 (30.0)

1 (11.1)

10 (52.6)

15 (35.7)

CBR, n (%)

2 (20.0)

1 (11.1)

3 (15.8)

6 (14.3)

mPFSd, days [95% CI]

47

79

121

79

[36.00,86.00]

[25.00, 97.00]

[42.00, 197.00]

[42.00, 116.00]

mDoRd, days

77

80

152

80

[95% CI]

[NE, NE]

[NE, NE]

[64.00, NE]

[64.00, NE]

  1. DL dose level, QD once daily, CR complete response, PR partial response, SD stable disease, ORR objective response rate, DCR disease control rate, CBR clinical benefit rate, mPFS median progression-free survival, mDoR median duration of response, CI confidence interval, NE not evaluated.
  2. aResponse assessed using RECIST 1.1.
  3. bDefined as confirmed CR + PR, excluding two patients without confirmed responses.
  4. cDefined as SD lasting ≥ 6 weeks, excluding eight patients whose SD lasted <6 weeks.
  5. dPFS and DoR were evaluated using the Kaplan–Meier estimates.
Back to article page