Table 1.
Patients’ baseline and disease characteristics
| MK-6482 (N=61) | |
|---|---|
| Age (years) | |
| Median | 41.0 |
| Min, Max | 19, 66 |
| Sex, n (%) | |
| Male | 32 (52) |
| Female | 29 (48) |
| Race, n (%) | |
| American Indian or Alaska Native | 0 |
| Asian | 1 (2) |
| Black or African American | 2 (3) |
| Native Hawaiian or Other Pacific Islander | 1 (2) |
| White | 55 (90) |
| Unknown | 2 (3) |
| ECOG Performance Status, n (%) | |
| 0 | 50 (82) |
| 1 | 10 (16) |
| 2 | 1 (2) |
| VHL Subtype, n (%) | |
| Type 1 | 51 (84) |
| Type 2A | 2 (3) |
| Type 2B | 6 (10) |
| Type 2C | 0 |
| Missing | 2 (3) |
| VHL disease associated non-RCC tumors 1 , n (%) | |
| Pancreatic Lesions2 | 31 (51) |
| Pheochromocytomas | 3 (5) |
| CNS Hemangioblastoma3 | 51 (84) |
| Endolymphatic Sac Tumors | 1 (2) |
| Epididymal Cystadenomas | 10 (16) |
| Retinal Lesions | 17 (28) |
| Other | 2 (3) |
| Median number of Prior Surgeries per patient 4 | 5 (range: 1 to 15) |
| Median time from initial radiographic diagnosis of VHL disease associated RCC tumors that led to enrollment to MK-6482-004 to the time of treatment with belzutifan | 18 months (range: 3 to 97) |
Note: Table adapted from FDA’s Multi-Discipline Review; there are no restrictions on its use (14).
1.
Per investigator assessment
3.
All 61 patients had at least one pancreatic lesion per IRC assessment.
2.
Twenty-four patients had a measurable solid lesion in CNS per IRC assessment.
4.
Forty-seven (77%) patients had prior surgical procedures for RCC.