The Efficacy and Safety of PD-1/PD-L1 Inhibitors in Combination with Conventional Therapies for Advanced Solid Tumors: A Meta-Analysis

Table 1

Characteristics of the RCT.

Study	Trial duration	Study type	Population	Treatment line	Experimental arm	Control arm		Follow-up (months)	Median OS (months)	High-grade AEs (no.) IOCT/non-IOCT
Antonia (2016)	2013-2015	Phase 1/2	SCLC	≥2	Nivolumab + ipilimumab	Nivolumab	213	12.0 vs. 8.67	6.0 vs. 4.4	10 vs. 13
Hodi (2016)	2013-2014	Phase 2	Melanoma	1	Nivolumab + ipilimumab	Ipilimumab	142	24.5	NR for both arms	51 vs. 9
Langer (2016)	2014-2016	Phase 2	NSCLC	1	Pembrolizumab + carboplatin + pemetrexed	Carboplatin + pemetrexed	123	10.6	NR for both arms	23 vs. 16
Wolchok (2017)	2013-2014	Phase 3	Melanoma	1	Nivolumab + ipilimumab	Ipilimumab; nivolumab	945	35.7 vs. 38 vs. 18.6	37.6 vs. NR vs. 19.9	184 vs. 86 vs. 67
D’Angelo (2018)	2015-2016	Phase 2	Sarcoma	≥2	Nivolumab + ipilimumab	Nivolumab	83	14.2	14.3 vs. 10.7	6 vs. 3
Gandhi (2018)	2016-2017	Phase 3	NSCLC	1	Chemotherapy + pembrolizumab	Chemotherapy + placebo	616	10.5	NR vs. 11.3	36 vs. 9
Long (2018)	2014-2017	Phase 2	Melanoma with brain metastases	≥1	Nivolumab + ipilimumab	Nivolumab	79	17	18.5 vs. NR	22 vs. 9
Socinski (2018)	2015-2016	Phase 3	NSCLL	1	Atezolizumab + bevacizumab + carboplatin + paclitaxel	Bevacizumab + carboplatin + paclitaxel	692	15.4	19.2 vs. 14.7	230 vs. 197
Horn (2018)	2016-2017	Phase 3	SCLC	1	Atezolizumab + carboplatin + Etoposide	Placebo + carboplatin + Etoposide	403	13.9	12.3 vs. 10.3	115 vs. 113
Motzer (2018)	2014-2016	Phase 3	RCC	1	Nivolumab + ipilimumab	Sunitinib	847	25.2	NR vs. 26	250/547 vs. 335/535^#
Antonia (2018)	2014-2016	Phase 3	NSCLC	1	Durvalumab + chemoradiotherapy	Placebo + chemoradiotherapy	713	25.2	NR vs. 38.7	145 (30.5%) vs. 61 (26.1%)^¶
Paz-Ares (2018)	2016-2016	Phase 3	NSCLC	1	Chemotherapy + pembrolizumab	Chemotherapy + placebo	559	7.8	15.9 vs. 11.3	194 vs. 191

Abbreviations: NSCLC: nonsmall cell lung cancer; SCLC: small cell lung cancer; RCC: renal cell carcinoma; OS: overall survival; NR: not reached; AE: adverse event; IOCT: immuno-oncology combination treatment. Experimental arm included two cohorts: 1 mg/kg nivolumab plus 3 mg/kg ipilimumab (61 patients) and 3 mg/kg nivolumab plus 1 mg/kg ipilimumab (54 patients). We included the latter cohort in the present study. ^#The high-grade AEs were reported among the intention-to-treat population. One patient in the experimental arm and three patients in the control arm were excluded from the safety analysis.