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Journal of Peking University (Health Sciences) ›› 2022, Vol. 54 ›› Issue (5): 971-980. doi: 10.19723/j.issn.1671-167X.2022.05.026

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Atezolizumab therapy in Chinese patients with locally advanced or metastatic solid tumors: An open-label, phase Ⅰ study

Li ZHANG1,Ji-fang GONG2,Hong-ming PAN3,Yu-xian BAI4,Tian-shu LIU5,Ying CHENG6,Ya-chi CHEN7,Jia-ying HUANG8,Ting-ting XU8,Fei-jiao GE8,Wan-ling HSU9,Jane SHI10,Xi-chun HU11,*(),Lin SHEN2,*()   

  1. 1. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
    2. Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education; Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China
    3. Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310020, China
    4. Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China
    5. Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
    6. Department of Medical Oncology, Jilin Cancer Hospital, Changchun 130012, China
    7. Clinical Pharmacology, Genentech, Inc., South San Francisco, CA 94080, USA
    8. Oncology, Roche Product Development Shanghai, Shanghai, 201203, China
    9. Department of Statistics, Roche Product Development Shanghai, Shanghai 201203, China
    10. Portfolio Clinical Safety, Roche Product Development Shanghai, Shanghai 201203, China
    11. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China
  • Received:2022-07-08 Online:2022-10-18 Published:2022-10-14
  • Contact: Xi-chun HU,Lin SHEN E-mail:xchu2009@hotmail.com;linshenpku@163.com

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Abstract:

Objective: To evaluate pharmacokinetics (PK), efficacy, and safety of atezolizumab (anti-PD-L1) in high interest cancers in China, including esophageal cancer (EC), gastric cancer (GC), hepatocellular carcinoma (HCC), nasopharyngeal cancer (NPC), and non-small cell lung can-cer (NSCLC). Methods: This phase I, open-label study was conducted at 6 Chinese sites from August 4, 2016 to April 15, 2019. The patients were ≥18 years old with a histologically documented incurable or metastatic solid tumor that was advanced or recurrent and had progressed since the last anti-tumor the-rapy. The PK phase characterized PK and safety of atezolizumab following multiple-dose administration when atezolizumab was administered as a single agent. The extension phase studied safety and efficacy of atezolizumab, as monotherapy (EC, GC, HCC, NPC) and with chemotherapy (NSCLC). Results: This study enrolled 120 patients (PK phase: n=20; extension phase: n=20/cohort). Fourty-two patients (42.0%) were PD-L1 positive in atezolizumab monotherapy group (100 patients), of the 9 patients (9.0%) with microsatellite instability-high (MSI-H) tumors. Atezolizumab clearance was 0.219 L/d, and steady state was reached after 6 to 9 weeks (2-3 cycles) of repeated dosing. Objective response rates (ORRs) in EC, GC, HCC, NPC, and NSCLC were 10.0%, 15.0%, 10.0%, 5.0%, and 40.0%, respectively. In the patients with PD-L1 positive tumors, ORR was 11.9% with atezolizumab and 46.2% with atezolizumab plus gemcitabine and cisplatin. Two GC patients achieved durable response after pseudo-progression. The most common treatment-related adverse events in the atezolizumab monotherapy group were fatigue, anemia, fever, and decreased white blood cell count. The most common treatment-related adverse events in the combination group were anemia, decreased white blood cell count, and decreased appetite. No new safety signals were identified. Conclusion: Atezolizumab's PK, efficacy, and safety were similar in Chinese patients vs. global patients in previous studies.

Key words: Atezolizumab, Pharmacokinetics, China, Neoplasms

CLC Number: 

  • R730.51

Figure 1

Study schema EC, esophageal cancer; GC, gastric cancer; HCC, hepatocellular carcinoma; NPC, nasopharyngeal cancer; NSCLC, non-small cell lung can-cer; q3w, every 3 weeks."

Table 1

Demographic and baseline characteristics"

Items Atezolizumab (n=100) Atezolizumab+gemcitabine+cisplatin (n=20)
Age/years, median (range) 55.0 (19.0-77.0) 60.0 (38.0-77.0)
Age < 65 years, n(%) 81 (81.0) 14 (70.0)
Male, n(%) 80 (80.0) 18 (90.0)
Weight/kg, Median (Range) 60.0 (33.0-96.0) 64.5 (47.0-94.0)
Study cohort
  EC (PD-L1+/PD-L1-), n 20 (10/10) NA
  GC (PD-L1+/PD-L1-/EBV+/MSI-H), n 20 (6/14/10/5) NA
  HCC (PD-L1+/PD-L1-), n 20 (8/12) NA
  NPC (PD-L1+/PD-L1-), n 20 (15/5) NA
  NSCLC (PD-L1+/PD-L1-), n NA 20 (13/7)
  PK (NSCLC/CRC/GC/UC/EC/HCC/BTC/NET)，n 20 (7/4/4/1/1/1/1/1) NA
ECOG performance score, n(%)
  0 21 (21.0) 0
  1 79 (79.0) 20 (100.0)
PD-L1+a, n(%) 42 (42.0) 13 (65.0)
PD-L1 IC scoreb, n(%)
  IC0 63 (63.0) 10 (50.0)
  IC1 26 (26.0) 6 (30.0)
  IC2 3 (3.0) 2 (10.0)
  IC3 5 (5.0) 1 (5.0)
  Unknown 3 (3.0) 1 (5.0)
PD-L1 TC scorec, n(%)
  TC0 81 (81.0) 13 (65.0)
  TC1 5 (5.0) 1 (5.0)
  TC2 10 (10.0) 1 (5.0)
  TC3 1 (1.0) 4 (20.0)
  Unknown 3 (3.0) 1 (5.0)
Tobacco use, n(%)
  Current 6 (6.0) 0
  Previous 40 (40.0) 14 (70.0)
  Never 54 (54.0) 6 (30.0)
Alcohol use, n(%)
  Current 5 (5.0) 0
  Previous 32 (32.0) 11 (55.0)
  Never 63 (63.0) 9 (45.0)
Prior radiotherapy, n(%) 43 (43.0) 4 (20.0)
MSI-H (all cancer types), n(%) 9 (9.0) 0
Prior therapy for recurrent/metastatic disease, n(%) 91 (91.0) 1 (5.0)

Figure 2

Atezolizumab concentrations in PK cohort Atezolizumab 1 200 mg administered every 3 weeks."

Table 2

Summary statistics for serum atezolizumab PK parameters in cycle 1 in PK cohort (n=20)"

Items Cmax/(mg/L) Cmin/(mg/L) AUC0-21/[d·(mg/L)] AUC0-∞a/[d·(mg/L)] CLb/(mL/d)
n 20 20 20 13 13
Mean (CV) 542 (22.3%) 102 (26.0%) 4 510 (16.6%) 5 710 (19.6%) 219 (21.2%)
SD 121 26.5 749 1 120 46.4
Minimum 377 56.1 2 970 3 780 165
Median 520 105 4 530 5 970 201
Maximum 887 143 6 100 7 280 317
GM (CV) 530 (20.9%) 98.7 (28.7%) 4 450 (17.2%) 5 600 (20.7%) 214 (20.7%)

Table 3

Efficacy summary by cohorts"

Items Atezolizumab (n=100) Atezolizumab+ gemcitabine+ cisplatin (n=20)
EC (n=20) GC (n=20) HCC (n=20) NPC (n=20) PK (n=20) NSCLC (n=20)
ORR (95%CI)/% 10.0 (1.23-31.70) 15.0 (3.21-37.89) 10.0 (1.23-31.70) 5.0 (0.13-24.87) 10.0 (1.23-31.70) 40.0 (19.12-63.95)
  CR, n(%) 0 0 0 0 0 0
  PR, n(%) 2 (10.0) 3 (15.0) 2 (10.0) 1 (5.0) 2 (10.0) 8 (40.0)
  SD, n(%) 6 (30.0) 7 (35.0) 10 (50.0) 12 (60.0) 7 (35.0) 10 (50.0)
  DCRa, n(%) 8 (40.0) 10 (50.0) 12 (60.0) 13 (65.0) 9 (45.0) 18 (90.0)
  PD, n(%) 7 (35.0) 7 (35.0) 7 (35.0) 7 (35.0) 11 (55.0) 1 (5.0)
  NE, n(%) 0 0 0 0 0 0
  Missing, n(%) 5 (25.0) 3 (15.0) 1 (5.0) 0 0 1 (5.0)
Median DOR (95%CI)/months 14.4 (8.0-20.8) 18.4 (NE) NE (6.9-NE) 8.3 (NE) NA NE (5.6-NE)
Median PFS (95%CI)/months 1.4 (1.4-2.8) 2.7 (1.4-4.4) 2.8 (1.4-7.8) 3.5 (1.4-7.0) NA 5.8 (5.5-9.6)
Median OS (95%CI)/months 4.8 (2.1-10.9) 9.7 (3.7-27.6) 7.8 (4.7-NE) 13.9 (8.2-21.3) NA NE (9.6-NE)
6-month OS rate (95%CI)/% 40 (19-61) 52 (29-75) 61 (39-84) 90 (77-100) NA 89 (74-100)
1-year OS rate (95%CI)/% 25 (6-44) 37 (13-61) 43 (19-66) 57 (34-80) NA 66 (27-100)
Duration of follow-up/months, M (Range) 4.76 (0.3-29.9) 7.41 (1.2-29.2) 12.16 (0.7-29.2) 14.93 (1.7-26.3) 15.21 (2.4-27.5) 6.95 (0.8-14.6)

Table 4

Efficacy summary by biomarker status"

Items PD-L1+ (n=55) PD-L1- (n=62) MSI-H (n=9)
Atezolizumab (n=42) Atezolizumab + gemcitabine + cisplatin (n=13) Atezolizumab (n=56) Atezolizumab + gemcitabine + cisplatin (n=6) Atezolizumab (n=9)
ORR (95%CI)/% 11.9 (3.98-25.63) 46.2 (19.22-74.87) 8.9 (2.96-19.62) 33.3 (4.33-77.72) 11.1 (0.28-48.25)
  CR, n(%) 0 0 0 0 0
  PR, n(%) 5 (11.9) 6 (46.2) 5 (8.9) 2 (33.3) 1 (11.1)
  SD, n(%) 16 (38.1) 5 (38.5) 25 (44.6) 4 (66.7) 4 (44.4)
  DCRa, n(%) 21 (50.0) 11 (84.6) 30 (53.6) 6 (100.0) 5 (55.6)
  PD, n(%) 17 (40.5) 1 (7.7) 21 (37.5) 0 4 (44.4)
  NE, n(%) 0 0 0 0 0
  Missing, n(%) 4 (9.5) 1 (7.7) 5 (8.9) 0 0
Median DOR (95%CI)/months 20.8 (6.9-20.8) NE (5.6-NE) 17.1 (8.0-NE) NE (NE) NE
Median PFS (95%CI)/months 2.8 (1.4-4.4) 6.9 (5.5-NE) 2.7 (1.4-3.8) 5.8 (3.3-NE) 4.2 (1.4-15.0)
Median OS (95%CI)/months 14.9 (6.1-29.9) NE (9.6-NE) 9.7 (6.6-13.2) NE (3.8-NE) 15.0 (9.7-NE)
6-month OS rate (95%CI)/% 67 (52-82) 100 (100-100) 64 (52-77) 67 (29-100) 78 (51-100)
1-year OS rate (95%CI)/% 50 (34-67) 75 (33-100) 39 (26-52) NE (NE) 65 (32-97)
Duration of follow-up/months, M (Range) NA NA NA NA NA

Table 5

Saftey summary on atezolizumab monotherapy and atezolizumab combined with chemotherapy"

Items Atezolizumaba (n=100) Atezolizumab+gemcitabine+cisplatina (n=20)
Patients with ≥1 AE, n(%) 98 (98.0) 20 (100.0)
  Serious AEs 41 (41.0) 8 (40.0)
    Leading to treatment discontinuation 16 (16.0) 0
    Leading to any dose modification/interruptionb 12 (12.0) 2 (10.0)
    Treatment-related 18 (18.0) 7 (35.0)
  AEs leading to treatment discontinuation 17 (17.0) 0
  AEs leading to any dose modification/interruptionb 28 (28.0) 4 (20.0)
  Treatment-related AEs 84 (84.0) 20 (100.0)
    Leading to treatment discontinuation 7 (7.0) 0
    Leading to any dose modification/interruptionb 17 (17.0) 2 (10.0)
  Grade 3/4 AEs 51 (51.0) 17 (85.0)
    Treatment-related 31 (31.0) 17 (85.0)
  Grade 5 AEs 11 (11.0) 1 (5.0)
    Treatment-related 1 (1.0)d 0
  AESIs 64 (64.0) 12 (60.0)
AEs, n 913 399
Deathsc, n(%) 71 (71.0) 3 (15.0)
Withdrawal from study due to an AE, n(%) 0 0

Table 6

Adverse events in the atezolizumab monotherapy arm"

Items Atezolizumaba(n=100) Items Atezolizumaba(n=100)
AEs (≥10%), n(%) 98 (98.0) AEs leading to treatment discontinuation, n(%) 17 (17.0)
  Aspartate aminotransferase increased 30 (30.0)   Hepatic function abnormal 3 (3.0)
  Anemia 29 (29.0)   Death 2 (2.0)
  Pyrexia 28 (28.0)   Dyspnea 2 (2.0)
  Alanine aminotransferase increased 26 (26.0)   Aspartate aminotransferase increased 1 (1.0)
  Decreased appetite 24 (24.0)   Blood creatinine phosphokinase increased 1 (1.0)
  Fatigue 24 (24.0)   Esophagobronchial fistula 1 (1.0)
  Blood bilirubin increased 24 (24.0)   Fistula 1 (1.0)
  White blood cell count decreased 22 (22.0)   Hyponatremia 1 (1.0)
  Neutrophil count decreased 16 (16.0)   Neoplasm progression 1 (1.0)
  Bilirubin conjugated increased 15 (15.0)   Pneumonia fungal 1 (1.0)
  Hyponatremia 13 (13.0)   Polymyositis 1 (1.0)
  Weight decreased 13 (13.0)   Sudden death 1 (1.0)
  Proteinuria 13 (13.0)   Transaminases increased 1 (1.0)
  Upper respiratory tract infection 13 (13.0)
  Nausea 11 (11.0)
  Hypoalbuminemia 10 (10.0)

Table 7

Adverse events in the atezolizumab plus gemcitabine and cisplatin arm(≥10%)"

Items Atezolizumab+ gemcitabine+ cisplatina (n=20)
Anemia 15 (75.0)
Decreased appetite 13 (65.0)
White blood cell count decreased 13 (65.0)
Nausea 11 (55.0)
Platelet count decreased 11 (55.0)
Neutrophil count decreased 10 (50.0)
Neutropenia 8 (40.0)
Vomiting 8 (40.0)
Alanine aminotransferase increased 7 (35.0)
Hypoalbuminemia 6 (30.0)
Leukopenia 6 (30.0)
Thrombocytopenia 6 (30.0)
Fatigue 5 (25.0)
Pyrexia 5 (25.0)
Rash 5 (25.0)
Aspartate aminotransferase increased 4 (20.0)
Asthenia 4 (20.0)
Hyponatremia 4 (20.0)
Lymphocyte count decreased 4 (20.0)
Productive cough 4 (20.0)
Blood lactate dehydrogenase increased 3 (15.0)
Bone marrow failure 3 (15.0)
Chest pain 3 (15.0)
Constipation 3 (15.0)
Gamma-glutamyltransferase increased 3 (15.0)
Hemoptysis 3 (15.0)
Hypoproteinemia 3 (15.0)
Weight decreased 3 (15.0)
Abdominal discomfort 2 (10.0)
Amylase increased 2 (10.0)
Bilirubin conjugated increased 2 (10.0)
Blood bilirubin increased 2 (10.0)
Blood creatinine increased 2 (10.0)
Hypochloremia 2 (10.0)
Hypokalemia 2 (10.0)
Hypothyroidism 2 (10.0)
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