Table 2 Efficacy summary in the R/R LBCL overall population (that is, all patients with R/R LBCL in the dose-escalation and dose-expansion cohorts; n = 117) and the dose-expansion cohort (R/R LBCL; efficacy-evaluable population; n = 98)

From: Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial

 

Overall population, n = 117a

Dose-expansion cohort, n = 98

INV

INV

IRC

Best ORR, n (%) [95% CI]

73 (62.4) [53.0–71.2]

62 (63.3) [52.9–72.8]

58 (59.2) [48.8–69.0]

Best complete response rate, n (%) [95% CI]

59 (50.4) [41.0–59.8]

50 (51.0) [40.7–61.3]

45 (45.9) [35.8–56.3]

ORR at time of PRA, n (%) [95% CI]b

 

46 (46.9) [36.8–57.3]

45 (46.0) [35.8–56.3]

Complete response rate at time of PRA, n (%) [95% CI]b

 

42 (42.9) [32.9–53.3]

42 (42.9) [32.9–53.3]

Median time to first response (range), months

2.7 (2.0–6.0)

2.7 (2.0–6.0)

2.6 (1.0–6.0)

Median DoR (95% CI), months

20.8 (14.8–NE)

20.5 (14.0–NE)

20.8 (14.2–NE)

 Event-free rate (95% CI), %

  12 months

65.5 (53.9–77.0)

64.1 (51.3–76.8)

68.5 (55.6–81.4)

  24 months

49.6 (36.0–63.2)

46.7 (31.5–61.9)

49.7 (34.3–65.2)

Median time to first complete response, months (range)

2.8 (2.0–8.0)

2.8 (2.0–8.0)

2.7 (2.0–6.0)

Median DoCR (95% CI), months

NE (16.2–NE)

NE (16.1–NE)

NE (20.5–NE)

 Event-free rate (95% CI), %

  12 months

75.2 (63.4–87.0)

73.4 (60.4–86.4)

82.1 (70.0–94.2)

  24 months

57.6 (42.2–73.0)

51.9 (34.5–69.2)

60.8 (43.2–78.4)

Median PFS (95% CI), months

9.4 (5.6–16.9)

9.4 (5.6–16.9)

11.4 (6.2–18.7)

 Event-free rate (95% CI), %

  12 months

45.8 (36.4–55.2)

45.2 (35.0–55.4)

48.2 (37.3–59.0)

  24 months

31.6 (21.9–41.3)

29.4 (18.8–39.9)

31.3 (20.1–42.6)

Median EFS, monthsb

 

6.0 (5.4–11.9)

6.9 (5.4–14.0)

 Event-free rate (95% CI), %

  12 months

 

39.3 (29.4–49.2)

42.1 (31.9–52.3)

  24 months

 

28.1 (18.2–37.9)

28.4 (18.4–38.4)

Median overall survival (95% CI), months

27.7 (15.2–NE)

23.3 (14.8–NE)

 Event-free rate (95% CI), %

  12 months

65.7 (56.9–74.6)

64.9 (55.2–74.5)

  24 months

51.3 (41.6–61.0)

48.6 (37.9–59.3)

  1. Note: In the 62 patients with INV-assessed response, the median DoR and the median DoCR were calculated from 61 patients, as one patient had partial response and progressive disease at the same assessment.
  2. aThree patients with histologically confirmed grade 1–3a FL were excluded from the efficacy analysis.
  3. bSecondary endpoint for the dose-expansion cohort only.
  4. EFS, event-free survival.
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