Table 1.
Summary of main prospective available data related to the efficacy of radiotherapy and ICI combination.
| Population | Reference | Phase | Intervention | Results |
|---|---|---|---|---|
| Locally advanced NSCLC | [31] | I | Pembrolizumab + chemoradiotherapy | 6-mo PFS rate = 81% |
| 12-mo PFS rate = 69.7% | ||||
| Median PFS = 18.7 mo | ||||
| Locally advanced NSCLC | PACIFIC [32,33,34] | III | Durvalumab (12 mo) as consolidation therapy vs. placebo (12 mo) | ORR = 28.4% vs. 16.0% (p < 0.001) |
| Median PFS = 16.8 mo vs. 5.6 (p < 0.001) | ||||
| 36 months OS = 55.3% vs. 43.5% | ||||
| Locally advanced NSCLC | [35] | II | Chemoradiation + pembrolizumab (12 mo) as consolidation therapy | Time to metastatic disease = 30.7 mo |
| PFS = 18.7 mo | ||||
| OS = 35.8 mo | ||||
| 1–4 metastatic sites NSCLC | [36] | II | Pembrolizumab within 4–12 weeks after locally ablative therapy | Median PFS from the start of locally ablative therapy = 19.1 mo |
| Locally advanced HNSCC | [37] | I | Cisplatin-based chemoradiotherapy + pembrolizumab (concurrently + as maintenance) | CR (HPV+) = 85.3% |
| CR (HPV−) = 78% | ||||
| Locally advanced HNSCC | JAVELIN H&N 100 [38] | III | Avelumab + chemoradiotherapy + avelumab maintenance vs. Placebo + chemoradiotherapy + placebo maintenance | At the time of the interim analysis: no significant improvement in PFS or OS |
| Locally advanced HNSCC (cisplatin-unfit patients) | PembroRad [39] | II | Once-daily RT up to 69.9 Gy associated with: Cetuximab vs. pembrolizumab | Loco-regional-control at 15 mo = 59% vs. 50% (p = 0.91) |
| 24-mo PFS = 40% vs. 42% (p = 0.41) | ||||
| 24-mo OS = 55% vs. 62% (p = 0.5) | ||||
| Stage III/IV RCC | RADVAX RCC [40] | II | Nivolumab + ipilimumab + SBRT (40–50 Gy in 5 fractions) | PR = 56% |
| SD = 24% | ||||
| PD = 16% | ||||
| 12-mo PFS rate = 36% | ||||
| 2nd or 3rd line RCC | NIVES [41] | II | Nivolumab + SBRT (10 Gy × 3 fractions 7 days after the 1st infusion of nivolumab) | ORR = 17.4% |
| 12-mo median OS = 73.4% | ||||
| Metastatic Melanoma | [42] | I | RT (6–8 Gy, 2–3 times) followed by ipilimumab injections | PR = 18% |
| SD = 18% | ||||
| Metastatic Melanoma | [43] | I | Ipilimumab + RT (between 18–50 Gy, in 1–15 fractions) | Clinical benefit = 50% |
| PR = 15% | ||||
| CR = 15% | ||||
| Metastatic Melanoma | [44] | I | Nivolumab + ipilimumab + extracranial RT (30 Gy in 10 fractions or 27 Gy in 3 fractions) | PR outside of the irradiated volume: 6/19 No progression of irradiated metastases |
Abbreviations: mo: months; NSCLC: non-small cell lung carcinoma; ORR: objective response rate; CR: complete response; PR: partial response; OS: overall survival; PD: progressive disease; PFS: progression-free survival; RCC: renal cell carcinoma; RT: radiation therapy; SD: stable disease; SBRT: Stereotaxic Body Radiation Therapy.