Table 1.
Completed bintrafusp alfa studies
| Trial name | NCT | Phase | Enrollment | Bintrafusp alfa Dose | Status | Target population | Primary tumor type | Median age (range) | Prior lines of therapy (% received ≥ 2 prior anticancer therapies) | Median follow-up time | Median duration of treatment | Grade ≥ 3 treatment-related AEs | Confirmed best overall response | References |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 19 | 1 (n = 3), 3 (n = 3), 10 (n = 3), or 20 (n = 7) mg/kg IV Q2W or a 0.3 mg/kg dose followed by a 10 mg/kg dose (n = 3) | Completed | Metastatic or locally advanced solid tumors | Adenoid cystic carcinoma (n = 2), anal (n = 2), appendiceal (n = 1), bronchopulmonary carcinoid (n = 1), cervix uteri (n = 4), chordoma (n = 1), colorectal (n = 2), pancreatic (n = 5), small bowel (n = 1) | 56 (33–78) | 84 | N/A | 11.9 wk (range 4.0–41.9) | 4/19 (21.1%) | CR 5% (n = 1), PR 10% (n = 2), SD 31% (n = 6), PD 47% (n = 9), NE 5% (n = 1) | [80] |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 80 | 500 mg or 1200 mg IV Q2W | Completed | Advanced NSCLC that progressed after platinum doublet therapy, platinum-based adjuvant or neoadjuvant treatment, and those who also have not received previous immunotherapy | NSCLC (squamous, n = 16 and nonsquamous, n = 64) | 64 (38–85) | 21.3 | 51.9 wk (IQR 19.6–74.0) | 11.9 wk (IQR 5.6–31.9) | 23/80 (28.8%) | PR 23.1% (n = 17), SD 16.3% (n = 13), PD 48.8% (n = 39), NE (n = 9) | [85] |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 32 | 1200 mg IV Q2W | Completed | Advanced SCCHN not amenable to curative therapy that progressed/recurred after platinum therapy in the recurrent/ metastatic setting, or < 6 mo after platinum therapy in the locally advanced setting | Advanced SCCHN | 60 (53–65) | 75 | 86.4 wk; range 2–97 | 12.1 wk (range 2–96) | 11/32 (34%) | PR 16% (n = 5), SD 19% (n = 6), PD 56% (n = 18), NE 9% (n = 3) | [109] |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors, and M7824 in Subjects With HPV Associated Malignancies | NCT02517398, and NCT03427411 | I and II | 59 | 0.3–30 mg/kg during dose-escalation or 1200 mg IV Q2W | Completed | Advanced, pretreated, checkpoint inhibitor-naive HPV-associated cancers | Cervical (n = 33), SCCHN (n = 15), anal (n = 6), rectal SCC (n = 2), vaginal (n = 1), vulvar (n = 1), neuroendocrine (n = 1) | 56 (48–64) | 66 | 9.2 mo | 3.9 mo (range 0.5–29.9) | 16/59 (27.1%) | CR 8.5% (n = 5), PR 22% (n = 13), SD 13.6% (n = 8), PD 45.8% (n = 27), NE 10.2% (n = 6) | [93] |
| MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors | NCT02699515 | I | 30 | 1200 mg IV Q2W | Completed | Asian patients with BTC whose disease progressed after first-line chemotherapy | Gallbladder cancer (n = 12), intrahepatic cholangiocarcinoma (n = 10), extrahepatic cholangiocarcinoma (n = 7), ampullary cancer (n = 1) | 67 (58–69) | 13 | 15.3 mo | 8.9 wk (IQR 5.7–32.1) | 11/30 (37%) | CR 3% (n = 1), PR 20% (n = 6), SD 13% (n = 4), PD 57% (n = 17), NE 7% (n = 2) | [88] |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 35 | 1200 mg IV Q2W | Completed | Recurrent glioblastoma that progressed after radiotherapy plus temozolomide | IDH mutant (n = 6), 15 patients (42.9%) had a prior gross total resection | 57 (28–75) | 8 | 19.7 mo (0.8–20.5) | 1.8 mo (range 0.5–20.7) | 6/35 (17.1%) | PR 5.7% (n = 2), SD 11.4% (n = 4), PD 71.4% (n = 25), NE 5.7% (n = 2) | [81] |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 30 | 1200 mg IV Q2W | Completed | Post-platinum, PD-L1-unselected esophageal adenocarcinoma | Adenocarcinoma (n = 30) | 61 (30–80) | 80 | 86.1 wk (2.0–55.7) | N/A | 7/30 (23.3%) | PR 13.3% (n = 4), SD 23.3% (n = 7), PD 40% (n = 12), NE 23.3% (n = 7) | [110] |
| MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors | NCT02699515 | I | 9 | 3 mg/kg (n = 3), 10 mg/kg (n = 6) IV Q2W | Completed | Asian patients with metastatic or locally advanced hepatocellular carcinoma | Hepatocellular carcinoma (n = 9) | 63 (39–71) | 33.3 | N/A | 5.9 wk (range 2–122) | 2/9 (22%) | SD 11.1% (n = 1), PD or NE 88.9% (n = 8) | [105] |
M7824 = Bintrafusp alfa
AEs adverse events, BTC biliary tract cancer, CR complete response, HPV human papillomavirus, IDH isocitrate dehydrogenase, IQR interquartile range, IV intravenously, N/A data not available or reported, NE not evaluable, NSCLC non-small-cell lung cancer, PD-L1 programmed cell death 1 ligand 1, PD progressive disease, PR progressive response, Q2W once every 2 weeks, SCCHN squamous cell carcinoma of the head and neck, SD stable disease