TABLE 3

18F-FDG PET Response at Recommended Phase II Dose for RO4987655 and RO5126766 on Cycle 1, Day 15

ResponseRO4987655 (8.5 mg twice daily)nRO5126766 (2.7 mg 4/3*)nP
SUVpeak reduction
 All tumors−47%8−16%4†0.052‡
  Mean–55%−13%
  Range−90% to 29%−48% to 11%
 Melanoma tumors−63%5−28%20.152‡
  Mean−61%−28%
  Range−90% to −36%−48% to −8%
Metabolic response
 All tumors75% PMR825% PMR4Not significant (P > 0.3)§
 Melanoma tumors83% PMR550% PMR2Not significant (P > 0.8)§

  • ↵* 4/3 = 4 days on treatment, 3 d off.

  • ↵† One patient escalated from 2.25 to 2.7 mg after single run-in dose.

  • ↵‡ One-sided t test.

  • ↵§ χ2 independence test.