Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial

Tianqing Chu; Jun Lu; Minghong Bi; Helong Zhang; Wu Zhuang; Yan Yu; Jianhua Shi; Zhendong Chen; Xiaochun Zhang; Qisen Guo; Quan Liu; Huijuan Wu; Jian Fang; Yi Hu; Xiuwen Wang; Cuicui Han; Kai Li; Baohui Han

doi:10.20892/j.issn.2095-3941.2020.0212

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Figure 1
Study flowchart.
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Figure 2
Equivalent therapeutic efficacy and safety were demonstrated between QL1101 and bevacizumab. (A) Similarity between QL1101 and bevacizumab was evaluated for the end-points of partial response, stable disease, progressive disease, not evaluated, complete response, and objective response rate. (B) Equivalence between QL1101 and bevacizumab was compared for safety including any treatment emergent adverse events (TEAEs), any serious TEAEs, any CTCAE ≥ 3 TEAE, any CTCAE ≥ 3 adverse drug response (ADR), neutrophil reduction, and leukopenia. (C, D) Similarities between QL1101 and bevacizumab were evaluated for the progression-free survival and overall survival end-points.
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Figure 3
Evaluation of equivalent therapeutic efficacy after excluding interference factors. (A) Equivalent overall survival (OS) evaluation in EGFR-mutated patients, excluding patients with a history of smoking and tumors. (B) After excluding the interference factors, better equivalence between QL1101 and bevacizumab was observed for the end-points of partial response, stable disease, progressive disease, not evaluated, complete response, and objective response rate. (C, D) After excluding interference factors, better equivalence between QL1101 and bevacizumab was found for the end-points of progression-free survival and overall survival.

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Table 1

Equivalent therapeutic efficacy between QL1101 and bevacizumab was evaluated for the subgroups of baseline characteristics

	PFS (days)				OS (days)
	QL1101^a	Bevacizumab^b	HR (95% CI)^c	P^d	QL1101^a	Bevacizumab^b	HR (95% CI)^c	P^d
Age (years)
< 65	168	161	1.055 (0.8632–1.290)	0.2749	Undefined	Undefined	1.096 (0.7898–1.522	0.3025
≥ 65	132	140	1.311 (0.9113–1.885)	2.128	504	501	1.034 (0.6868–1.557)	0.0256
Gender
Male	153	151	1.109 (0.8834–1.392)	0.7947	475	Undefined	1.288 (0.9342–1.775)	2.384
Female	141	150.1	1.138 (0.8627–1.502)	0.8381	Undefined	Undefined	0.880 (0.5257–1.473)	0.2364
Smoking history
Never	152	168	1.121 (0.8803–1.429)	0.8611	Undefined	Undefined	1.050 (0.6841–1.610)	0.0491
Ever	164	139	1.173 (0.8267–1.665)	0.8001	462	Undefined	1.610 (0.9893–2.619)	3.674
Still	136	134	0.9681 (0.6633–1.413)	0.0283	Undefined	466	0.8480 (0.5057–1.422)	0.3905
Pathology
Wild type	150	144	1.058 (0.8448–1.325)	0.2409	Undefined	566	1.003 (0.7329–1.374)	0.0275
EGFR mutation	151.5	169	1.188 (0.8967–1.573)	1.44	Undefined	Undefined	1.617 (0.9382–2.788)	2.994
Tumor history
Yes	152	177	1.281 (0.7342–1.439)	0.7609	Undefined	Undefined	0.651 (0.2440–1.736)	0.7354
No	151	148.5	1.089 (0.9050–1.311)	0.8161	Undefined	Undefined	1.175 (0.8854–1.560)	1.249
ECOG
0	155	132	0.8692 (0.6022–1.255)	0.5599	Undefined	Undefined	1.700 (0.9502–3.040)	3.196
1	151	170	1.192 (0.9752–1.456)	2.938	Undefined	Undefined	1.010 (0.7423–1.375)	0.004

^aThe bevacizumab analogue was sourced from Qilu Pharmaceutical Co., Ltd, China. ^bBevacizumab was sourced from Roche, China. ^cHazard ratio (HR) [95% confidence interval (CI)]. ^dChi-square value using the Mantel-Cox test. PFS, progression free survival; OS, overall survival; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor.

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Table 2

Equivalent therapeutic efficacy between QL1101 and bevacizumab was evaluated for the subgroups after excluding the interference factors.

	PFS (days)				OS (days)
	QL1101^a	Bevacizumab^b	HR (95% CI)^c	P^d	QL1101^a	Bevacizumab^b	HR (95% CI)^c	P^d
Age (years)
< 65	169	147	0.9985 (0.8014–1.244)	< 0.001	Undefined	Undefined	0.9792 (0.6854–1.399	0.0134
≥ 65	131	137	1.288 (0.8777–1.890)	1.673	459	508	1.150 (0.6985–1.894)	0.3025
Gender
Male	150	134	1.065 (0.825–1.374)	0.2321	459	566	1.161 (0.8203–1.643)	0.7084
Female	141	147	1.093 (0.8203–1.456)	0.3687	Undefined	Undefined	0.8216 (0.4839–1.395)	0.5290
Smoking history
Never	150	168	1.130 (0.8807–1.450)	0.9231	Undefined	Undefined	1.032 (0.6695–1.592)	0.0209
Ever	170	133	0.9533 (0.6372–1.426)	0.0541	459	497	1.004 (0.6791–1.484)	< 0.001
Still	130	121	0.9171 (0.5900–1.426)	0.1479	Undefined	396.5	0.6473 (0.3583–1.169)	2.078
Pathology
Wild type	150	144	1.058 (0.8448–1.325)	0.2409	Undefined	566	1.003 (0.7329–1.374)	0.0275
EGFR mutation	142.5	138	1.091 (0.7627–1.561)	0.2286	Undefined	Undefined	1.260 (0.5921–2.682)	0.3602
Tumor history
Yes	146	175	1.602 (0.7613–3.371)	1.541	Undefined	513	0.3735 (0.1200–1.163)	2.888
No	145	140	1.033 (0.8479–1.259)	0.8161	Undefined	Undefined	1.085 (0.8038–1.465)	0.2838
ECOG
0	158	132	0.7639 (0.5121–1.139)	1.744	Undefined	Undefined	1.281 (0.6763–2.426)	0.5772
1	144	154	1.174 (0.9451–1.459)	2.105	Undefined	Undefined	0.9589 (0.6922–1.328)	0.0638

^aBevacizumab biosimilar sourced from Qilu Pharmaceutical Co., Ltd, China. ^bBevacizumab sourced from Roche China. ^cHazard Ratio (95% CI of ratio. ^dChi square value using Mantel-Cox test.