Displaying One Session

Channel 3 Mini Oral session
Date
11.12.2020
Time
11:00 - 12:20
Room
Channel 3
Mini Oral session 1 Mini Oral session

24MO - Randomized, Multicenter, Open-label Trial of Autologous Cytokine-Induced Killer Cell Immunotherapy plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer: NCT01631357

Presentation Number
24MO
Lecture Time
11:05 - 11:10
Speakers
  • R. Xiubao (Tianjin, China)
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Authors
  • R. Xiubao (Tianjin, China)
  • Q. Gao (Zhengzhou, China)
  • J. Jiang (Changzhou, China)
  • J. Zhang (Taiyuan, China)
  • X. Song (Kunming, China)
  • J. Cui (Changchun, China)
  • Y. Ye (Fujian, China)
  • Z. Wang (Shijiazhuang, China)
  • H. Yao (Kunming, China)
  • X. Zhang (Tianjin, China)
  • X. Hao (Tianjin, China)
  • L. Liu (Tianjin, China)

Abstract

Background

There is no multicenter clinical study about cytokine-induced killer (CIK) cells in lung cancer. This randomized, multicenter trial was designed to evaluate the efficacy of CIK cell immunotherapy combination with chemotherapy in patients with advanced squamous non-small-cell lung cancer (NSCLC).

Methods

In this phase II trial, 90 patients with untreated, stage IIIB/IV squamous NSCLC were randomized to autologous CIK cell immunotherapy plus gemcitabine and cisplatin (CIK-CT group, n = 45), or gemcitabine and cisplatin (CT group, n = 45). The primary endpoint was progression-free survival (PFS) and secondary endpoint was overall survival (OS) evaluated by Kaplan–Meier analyses and treatment hazard ratios (HRs) with the Cox proportional hazards model.

Results

After a median follow-up of 29.3 months, the median PFS was 8.7 months (95% CI, 7.1 to 10.3) in the CIK-CT group and 4.0 months (95% CI, 3.1 to 5.0) in the CT group (HR, 0.26; 95% CI, 0.16 to 0.43; P < .001). The median OS was 21.0 months (95% CI, 17.8 to 24.2) in the CIK-CT group and 10.3 months (95% CI, 7.9 to 12.1) in the CT group (HR, 0.22; 95% CI, 0.13 to 0.40; P < .001). The objective response rate was 62.2% (95% CI, 47.9% to 76.5%) in the CIK-CT group and 31.1% (95% CI, 17.4% to 44.8%) in the CT group (P < .001). The adverse events of grade 3 or higher were 33.3% and 42.2% in the CIK-CT group and CT group, respectively.

Conclusions

These data suggested that the addition of CIK cell immunotherapy to chemotherapy resulted in significantly longer PFS and OS than chemotherapy alone in patients with previously untreated, advanced squamous NSCLC.

Clinical trial identification

ClinicalTrials.gov number, NCT01631357

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Mini Oral session 1 Mini Oral session

Invited Discussant 23MO and 24MO

Lecture Time
11:10 - 11:22
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Mini Oral session 1 Mini Oral session

Q&A and live discussion

Lecture Time
11:22 - 11:37
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Mini Oral session 1 Mini Oral session

30MO - ORIENT-3: A randomized, open-label, phase 3 study of sintilimab versus docetaxel in previously treated advanced/metastatic squamous non-small-cell lung cancer (sqNSCLC)

Presentation Number
30MO
Lecture Time
11:37 - 11:42
Speakers
  • Y. Shi (Beijing, China)
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Authors
  • Y. Shi (Beijing, China)
  • L. Wu (Changsha, China)
  • X. Yu (Hangzhou, China)
  • P. Xing (Beijing, China)
  • J. Zhou (Hangzhou, China)
  • A. Wang (Weihai, China)
  • J. Shi (Linyi, China)
  • Y. Hu (Beijing, China)
  • Z. Wang (Beijing, China)
  • G. An (Beijing, China)
  • Y. Fang (Hangzhou, China)
  • S. Sun (Xuzhou, China)
  • C. Zhou (Shanghai, China)
  • C. Wang (Tianjin, China)
  • F. Ye (Xiamen, China)
  • X. Li (Zhengzhou, China)
  • J. Wang (Jining, China)
  • M. Wang (Beijing, China)
  • Y. Liu (Shenyang, China)
  • Y. Zhao (Zhengzhou, China)

Abstract

Background

The survival benefit of second-line chemotherapy is dismal for patients (pts) with advanced sqNSCLC. ORIENT-3 was conducted to compare the efficacy and safety of sintilimab, an anti-PD-1 antibody, with docetaxel in second-line treatment in sqNSCLC. (NCT03150875)

Methods

Pts with stage IIIB/IIIC or IV (ineligible for radical chemo-radiotherapy) sqNSCLC who failed prior platimum-based chemotherapy were enrolled and randomized 1:1 to receive sintilimab 200mg (sint arm) or docetaxel 75mg/m2 (DXT arm) intravenously, Q3W until disease progression or intolerable toxicity. Stratification factor was ECOG score (0 vs. 1). The primary endpoint was overall survival (OS).

Results

As of July 31, 2020, 290 pts were enrolled with 145 in each treatment group. Efficacy analysis was based on FAS (n=280), and safety analysis was based on safety set (n=274). Baseline characteristics were well balanced between treatment groups, and most pts in efficacy analysis (75.9% in sint arm, 77.0% in DXT arm) had ECOG score of 1. Pts received a median of 8.0 cycles (range: 1-45) of sintilimab, and 2.0 cycles of docetaxel (range: 1-15). With a median follow-up of 23.56 months, sintilimab had a significant improvement in OS versus docetaxel (median: 11.79 m [95% CI, 10.28-15.57] vs. 8.25 m [95% CI, 6.47-9.82]; HR 0.74, [95%CI, 0.56 to 0.96], P = 0.02489). The median PFS was also significantly superior in sint arm (4.30 m, 95% CI, 4.04-5.78) to that in DXT arm (2.79 m, 95% CI, 1.91-3.19) (HR 0.52, 95% CI, 0.39-0.68, P<0.00001). The ORR was 27.6 % (95% CI, 20.5%-35.6%) in sint arm and 5.2% (95% CI, 2.1%-10.4%) in DXT arm. 84.7% of pts in sint arm and 83.1% in DXT arm reported treatment-related adverse events (AEs), most commonly with hypothyroidism (18.1%) and alopecia (34.6%), respectively. TRAEs ≥ grade 3 were less frequent in sint arm (18.1%) than in DXT arm (36.2%). Five pts occurred sintilimab related death, and one death reported relating with docetaxel.

Conclusions

Sintilimab as second-line treatment for advanced and metastatic sqNSCLC showed a superior OS and PFS, compared with docetaxel.

Clinical trial identification

NCT03150875

Editorial acknowledgement

We thank Xia Yin (Innovent Biologics, Inc.) for the writing and editorial assistance.

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Mini Oral session 1 Mini Oral session

62MO - A randomized, controlled, multicenter phase II trial of camrelizumab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant treatment in locally advanced NSCLC

Presentation Number
62MO
Lecture Time
11:42 - 11:47
Speakers
  • J. Lei (Xi’an City, China)
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Authors
  • J. Lei (Xi’an City, China)
  • X. Yan (Xi’an City, China)
  • J. Zhao (Xi’an City, China)
  • F. Tian (Xi’an City, China)
  • Q. Lu (Xi’an City, China)
  • T. Jiang (Xi’an City, China)

Abstract

Background

Camrelizumab (Cam), an anti-PD-1 antibody, could significantly increase the PFS and ORR in advanced non-squamous NSCLC vs chemotherapy (CT). However, the effect and safety of Cam plus CT in the neoadjuvant setting is unknown.

Methods

This interim analysis included 27 patients (pts) with locally advanced NCSLC. Treatment-naive pts with stage IIIA or IIIB-N2 resectable NSCLC, ECOG PS 0-1, were randomized (1:1) to receive intravenous Cam (200mg) on D1, albumin-bound paclitaxel (ab-Pac; 130 mg/m2) on D1 and 8, and cisplatin (Cis; 75 mg/m2) on D1 (Cam+CT group), or ab-Pac plus Cis (CT group) of a 21-day cycle for 3 cycles. Treatment was followed by surgery. The primary endpoint was pathologic complete response (pCR). Secondary endpoints included major pathologic response (MPR), ORR, DFS by RECIST 1.1, and safety. The immune-related gene profiles of pre- or post-treatment biopsies and serum were detected to construct the individualized immune signature for outcome prediction through a multicenter analysis. 94 patients were planned to be enrolled.

Results

At data cutoff (Sept 15, 2020), 27 pts were enrolled (14 in the Cam+CT group and 13 in the CT group). All pts received at least 1 cycle treatment. 14 pts completed neoadjuvant therapy and efficacy evaluation, among which 13 had surgery (7 in the Cam+CT group and 6 in the CT group) and 1 was pending for surgery. In the Cam+CT group, pCR was observed in 4/7 (57.1%) pts and MPR in 2 (28.6%); ORR was 86.7% (6/7; CR: 1, PR: 5). In the CT arm, 1/6 (16.7%) pts achieved pCR and 1 (16.7%) had MPR; ORR was 57.1% (4/7; CR: 1, PR: 3). DFS data was immature and gene profiles will be analyzed later. Adverse events (AEs) of the two arms were similar, except reactive cutaneous capillary endothelial proliferation (9/14 [64.3%]; all grade 1) in the Cam+CT arm. No AEs beyond expectation or of grade 4-5 were reported.

Conclusions

These interim results suggested camrelizumab plus CT may have a better effect as neoadjuvant therapy in locally advanced NSCLC. This trial is ongoing and final analysis will be conducted after study completion.

Clinical trial identification

NCT04338620

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Mini Oral session 1 Mini Oral session

Invited Discussant 30MO and 62MO

Lecture Time
11:47 - 11:59
Speakers
  • B. Besse (Villejuif, CEDEX, France)
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20
Authors
  • B. Besse (Villejuif, CEDEX, France)
Mini Oral session 1 Mini Oral session

Q&A and live discussion

Lecture Time
11:59 - 12:14
Session Name
Location
Channel 3, Geneva Palexpo, Geneva, Switzerland
Date
11.12.2020
Time
11:00 - 12:20