Table 2.
Preliminary Efficacy Parameters by IRC and Investigator per RANO
| Outcome (N = 35) | By IRC | By Investigator |
|---|---|---|
| BOR, n (%) | ||
| CR | 0 | 0 |
| PR | 2 (5.7) | 1 (2.9) |
| SDa | 4 (11.4) | 8 (22.9) |
| Non-CR/Non-PD | 2 (5.7) | 0 |
| PD | 25 (71.4) | 22 (62.9) |
| NE | 2 (5.7)b | 4 (11.4)c |
| DCR, n (%) [95% CI] | ||
| All | 8 (22.9) [10.4–40.1] | 9 (25.7) [12.5–43.3] |
| PD-L1 positive (≥1% tumor cells) | 4/24 (16.7) [4.7–37.4] | 4/24 (16.7) [4.7–37.4] |
| PD-L1 negative (<1% tumor cells) | 4/11 (36.4) [10.9–69.2] | 5/11 (45.5) [16.7–76.6] |
| IDH mutant | 4/6 (66.7) [22.3–95.7] | 4/6 (66.7) [22.3–95.7] |
| IDH wild-type | 4/29 (13.8) [3.9–31.7] | 5/29 (17.2) [5.9–35.8] |
| Median PFS, months (95% CI) | ||
| All | 1.4 (1.2–1.6) | 1.4 (1.2–1.6) |
| PD-L1 positive (≥1% tumor cells) | 1.3 (1.2–1.6) | 1.3 (1.2–1.5) |
| PD-L1 negative (<1% tumor cells) | 1.4 (1.2–19.3) | 1.4 (1.2–5.4) |
| IDH mutant | 13.0 (1.3-NR) | 11.3 (1.3-NR) |
| IDH wild-type | 1.3 (1.2–1.4) | 1.3 (1.2–1.4) |
| Median OS, months (95% CI) | ||
| All | 5.3 (2.6–9.4) | |
| IDH mutant | NR (7.2-NR) | |
| IDH wild-type | 3.7 (2.4–6.7) |
BOR, best overall response; CR, complete response; DCR, disease control rate; IDH, isocitrate dehydrogenase; IRC, independent review committee; NE, not evaluable; NR, not reached; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RANO, Response Assessment in Neuro-Oncology; SD, stable disease.
aDefined as a minimum duration of 6 weeks from baseline assessment. bIncludes 1 patient with no IRC review due to no postbaseline assessments and 1 patient classified as having no target lesions. cIncludes the 2 patients with NE per IRC in addition to 2 patients with all postbaseline assessments of NE per investigator, which were classified as PD per IRC.