Table 2.
Select clinical trials exploring combined TGFβ and immune checkpoint inhibition that have shared preliminary results.
| Anti-TGFβ and ICI Medications | Additional therapy | NCT identifier | Phase | Sample size | Response rate | Median OS (%) |
Median OS (Months) | Notes |
|---|---|---|---|---|---|---|---|---|
| Colorectal cancer | ||||||||
| Vactosertib + Pembrolizumab |
– | NCT03724851 | 2 | 33 | 15.2% | NR | NR | Pre-treated, ICI-naïve, MSS, metastatic CRC |
| NIS793 + Spartalizumab |
– | NCT02947165 | 1b | 40 | 5% | NR | NR | Advanced, Pre-treated, MSS CRC |
| Bintrafusp alfa | – | NCT03436563 | 2 | 15 | 0% | NR | 9.1 | MSI-H CRC |
| – | 1 | 4 | 0% | NR | NR | Liver-limited, ctDNA-positive, MSS mCRC | ||
| Pancreatic cancer | ||||||||
| Galunisertib + Durvalumab |
– | NCT02734160 | 1b | 32 | 3.125% | NR | 5.72 | Heavily pre-treated, Recurrent/refractory, metastatic PDAC |
| Bintrafusp alfa | – | NCT02517398 | 1 | 5 | 20% | NR | NR | Heavily pre-treated |
| Biliary tract cancers | ||||||||
| Bintrafusp alfa | – | NCT02699515 | 1 | 30 | 20% | NR | 12.7 | Pre-treated |
| Gastroesophageal cancers | ||||||||
| Bintrafusp alfa | – | NCT02699515 | 1 | 31 | 22.6% | NR | NR | Recurrent, locally advanced/metastatic gastric/gastroesophageal junction cancer |
| Bintrafusp alfa | – | NCT02517398 | 1 | 30 | 20% | NR | NR | Platinum-refractory esophageal adenocarcinoma |
| – | NCT02699515 | 1 | 30 | 10% | NR | 11.9 | Heavily pre-treated esophageal SCC | |
| Primary lung cancers | ||||||||
| Galunisertib + Nivolumab |
– | NCT02423343 | 2 | 25 | 24% | NR | 11.99 | Recurrent/refractory NSCLC |
| Bintrafusp alfa | – | NCT02517398 | 1 | 40 | 27.5% | 18-month: 49.7% 24-month: 39.7% |
NR | Advanced, platinum-treated NSCLC |
| Cervical cancer | ||||||||
| Bintrafusp alfa | – |
NCT02517398 NCT03427411 |
1 2 |
39 | 30.77% | NR | 13.4 | Pre-treated, recurrent/metastatic cervical cancer |
| Head and neck cancer | ||||||||
| Bintrafusp alfa | – | NCT02517398 | 1 | 32 | 12.5% | 18-month: 44.0% 24-month: 36.0% 36-month: 24.0% |
9.1 | Heavily pre-treated, advanced HNSCC |
| – | NCT04247282 | 1 | 14 | a86% | NR | NR | Previously untreated, surgically resectable HPV-unrelated HNSCC | |
| HPV-associated cancers | ||||||||
| Bintrafusp alfa | – |
NCT02517398 NCT03427411 |
1 2 |
39 | 32% | 12-month: 59.7% 18-month: 51.5% |
NR | Advanced, pre-treated HPV-associated cancers |
| NHS-IL12 PDS0101 |
NCT04287868 | 2 | 14 | 71% | NR | NR | HPV-positive, relapsed or refractory advanced cancers | |
| Neurologic malignancies | ||||||||
| Bintrafusp alfa | – | NCT02517398 | 1 | 35 | 5.71% | – | 5.3 | Recurrent GBM following radiation and Temozolomide treatment |
| Multi-cancer studies | ||||||||
| NIS793 + Spartalizumab |
– | NCT02947165 | 1b | 120 | 3.33% | NR | NR | Advanced or metastatic solid tumors |
Abbreviations: Transforming Growth Factor β (TGFβ); Immune checkpoint inhibitor (ICI); Overall survival (OS); Not reported (NR); Microsatellite stable (MSS); Colorectal cancer (CRC); Metastatic CRC (mCRC); Microsatellite instability-high (MSI-H); circulating tumor DNA (ctDNA); Pancreatic ductal adenocarcinoma (PDAC); Squamous cell carcinoma (SCC); Non-small cell lung cancer (NSCLC); Head and neck squamous cell carcinoma (HNSCC); Human papillomavirus (HPV); Glioblastoma multiforme (GBM).
a
Denotes pathologic response rate.