Table 2

Efficacy data summary

Primary endpointACC
n=45
Non-ACC
n=50
NPR6m33.3% (one-sided 95% CI 21.8 to NE)14.0% (one-sided 95% CI 6.8 to NE)
Pts alive without progression at 6 monthsn=15/45 (1 NE)n=7/50 (2 NE)
Secondary endpointsACC
n=46
Non-ACC
n=52
Median PFS (in months)43 PFS events
5.3 (95% CI 3.2 to 5.6)
51 PFS events
1.8 (95% CI 1.7 to 3.5)
Median OS (in months)26 OS events
17.2 (95% CI 12.5 to NE)
32 OS events
11.5 (95% CI 7.5 to 14.8)
Overall response rate (at best overall response)8.7% (95% CI 2.4 to 20.8)3.8% (95% CI 0.5 to 13.2)
 CR0 (0%)0 (0%)
 PR4 (8.7%)*2 (3.8%)†
 SD26 (56.5%)22 (42.3%)
 PD16 (34.8%)28 (53.8%)
  • *The histological types of the four ACC responders were soft pelate, larynx, paranasal sinuses and submandibular. Duration of best overall response was 3.2, 20.7, 9.7 and 5.9 months.

  • †The histological types of the two non-ACC responders were epidermoid and adenocarcinoma.

  • ACC, adenoid cystic carcinoma; CR, complete response; NPR6m, non-progression rate at 6 months; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.