Table 2.
Overall safety summary and subsequent cancer therapies.
| Venetoclax plus fulvestrant | Fulvestrant | |
|---|---|---|
| n = 50 | n = 51 | |
| ≥1 AE | 47 (94.0) | 39 (76.5) |
| Total AEs | 399 | 218 |
| Grade 3–4 AEsa | 13 (26.0) | 6 (11.8) |
| SAEs | 4 (8.0) | 1 (2.0) |
| SAEs leading to death | 1 (2.0) | 0 |
| Urosepsis (unrelated to study drug) | 1 (2.0) | NA |
| AEs related to study drugb | 43 (86.0) | 26 (51.0) |
| Venetoclax | 43 (86.0) | NA |
| Grade 1–2 | 32 (64.0) | NA |
| Grade 3–4 | 11 (22.0) | NA |
| Fulvestrant | 27 (54.0) | 26 (51.0) |
| Related AEs leading to drug withdrawalc | 4 (8.0) | 0 |
| Venetoclax | 4 (8.0) | NA |
| Fulvestrant | 1 (2.0) | 0 |
| AEs leading to dose modification/interruption | 22 (44.0) | 1 (2.0) |
| Deaths | 19 (38.0) | 9 (17.6) |
| ≤28 days following last dose | 2 (4.0) | 0 |
| AE | 1 (2.0)d | 0 |
| PD | 1 (2.0) | 0 |
| >28 days following last dose | 17 (34.0) | 9 (17.6) |
| PD | 16 (32.0) | 8 (15.7) |
| Other | 1 (2.0) | 1 (2.0) |
| Pneumonia | 0 | 1 (2.0) |
| Post-study reporting death | 1 (2.0) | 0 |
| Subsequent cancer therapiese | n = 51 | n = 52 |
| Radiotherapy | 7 (13.7) | 8 (15.4) |
| Bone | 3 (5.9) | 4 (7.7) |
| Brain | 3 (5.9) | 3 (5.8) |
| Antineoplastic agentsf | 35 (68.6) | 41 (78.8) |
| Capecitabine | 19 (37.3) | 24 (46.2) |
| Paclitaxel | 9 (17.6) | 9 (17.3) |
| Everolimus | 2 (3.9) | 10 (19.2) |
| ETf | 5 (9.8) | 13 (25.0) |
| Exemestane | 4 (7.8) | 10 (19.2) |
Note: Safety-evaluable population (one patient in each arm did not receive study drug). Data are n (%).
Abbreviations: AE, adverse event; ET, endocrine therapy; ITT, intention-to-treat; NA, not applicable; PD, progressive disease; SAE, serious adverse event.
aDifference in incidence of grade 3–4 AEs between the venetoclax plus fulvestrant arm versus the fulvestrant arm was driven by neutropenia [six patients (12.0%) versus zero patients, respectively].
bAEs were mainly grade 1–2 and manageable.
cAll study drugs.
dFatal urosepsis SAE unrelated to study drug.
eITT population.
fAntineoplastic agents and ET reported are those used by >10% of patients in either treatment arm.