Table 4.
Summary details of overall survival based on objective response rate, primary tumor site, and NUC‐1031 dose (mg/m2) (efficacy evaluable population)
| Patient | Change in tumor volume (%) | Primary tumor site | NUC‐1031 a dose (mg/m2) | Overall survival (months) | Treatment after ABC‐08 | Status at end of trial follow‐up |
|---|---|---|---|---|---|---|
| 6 | −100 | AMP | 625 | 10.7 | No | Dead |
| 5 | −54 | DBD | 625 | 25.8 | Cisplatin/gemcitabine | Dead |
| 2 | −51 | IHC | 625 | 36.0 | SIRT | Alive |
| 12 | −50 | Hilar | 725 | 20.0 | No | Alive |
| 17 | −46 | IHC | 625 | 7.2 | No | Dead |
| 8 | −43 | GBC | 625 | 8.7 | No | Dead |
| 10 | −39 | Hilar | 725 | 6.7 | No | Dead |
| 15 | −28.3 | DBD | 625 | 6.4 | No | Dead |
| 18 | −26 | IHC | 625 | 10.0 | No | Dead |
| 21 | −21 | GBC | 625 | 9.6 |
Irinotecan/capecitabine/ trastuzumab |
Dead |
| 13 | 0 | Hilar | 725 | 16.3 | No | Alive |
| 16 | +6 | Hilar | 625 | 13.1 | No | Dead |
| 7 | +10 | AMP | 625 | 17.2 | Surgical resection + adjuvant gemcitabine | Dead |
| 9 | +12 | DBD | 725 | 8.0 | No | Dead |
| 4 | +21 | IHC | 625 | 10.1 | Oxaliplatin/5‐fluorouracil/folinic acid | Dead |
| 20 | +60 | Hilar | 625 | 4.7 | No | Dead |
Change in tumor volume (%) based on RECIST version 1.1 (efficacy evaluable population: 16 patients with measurable disease who received at least one cycle of NUC‐1031 with cisplatin and had at least one follow‐up radiographic assessment). An additional patient did not have measurable disease (best response based on nontarget lesion was noncomplete response/nonprogressive disease); two patients did not receive any treatment on ABC‐08 beyond cycle 1, day 1 because of cholangitis and raised gamma‐glutamyl transferase (surviving 5.0 and 21.2 months, respectively), and two patients did not have follow‐up imaging beyond baseline, having died at 1.5 and 3.6 months, respectively.
In combination with cisplatin 25 mg/m2 on days 1 and 8 (21‐day schedule).
Abbreviations: AMP, ampulla of Vater carcinoma; DBD, distal bile duct cholangiocarcinoma; IHC, intrahepatic cholangiocarcinoma; GBC, gallbladder cancer; SIRT, selective internal radiation therapy.