Table 3: Efficacy Results by Tumor Type in Patients with RET Fusion-Positive Solid Tumors in Study LIBRETTO-001.
| Tumor Type | Patients (n = 41) | ORR1,2 | DOR Range (months) | |
|---|---|---|---|---|
| n (%) | 95% CI | |||
| Pancreatic adenocarcinoma | 11 | 6 (55%) | (23, 83) | 2.5, 38.3+ |
| Colorectal | 10 | 2 (20%) | (2.5, 56) | 5.6, 13.3 |
| Salivary | 4 | 2 (50%) | (7, 93) | 5.7, 28.8+ |
| Unknown primary | 3 | 1 (33%) | (0.8, 91) | 9.2 |
| Breast | 2 | PR, CR | NA | 2.3+, 17.3 |
| Sarcoma (soft tissue) | 2 | PR, SD | NA | 14.9+ |
| Xanthogranuloma | 2 | NE, NE | NA | NA |
| Carcinoid (bronchial) | 1 | PR | NA | 24.1+ |
| Carcinoma of the skin | 1 | NE | NA | NA |
| Cholangiocarcinoma | 1 | PR | NA | 5.6+ |
| Ovarian | 1 | PR | NA | 14.5+ |
| Pulmonary carcinosarcoma | 1 | NE | NA | NA |
| Rectal neuroendocrine | 1 | NE | NA | NA |
| Small intestine | 1 | CR | NA | 24.5 |
+
denotes ongoing response.
1
Confirmed overall response rate assessed by BIRC.
2
Best overall response for each patient is presented for tumor types with ≤2 patients.
CI = confidence interval, CR = complete response, DOR = duration of response, NA = not applicable, NE = not evaluable, ORR = overall response rate, PR = partial response, SD = stable disease.
Source: U.S. product labeling, RETEVMO (selpercatinib)5