- Andrew Furness (London, United Kingdom)
- Benjamin Besse (Villejuif, France)
Randomized, multicenter, open-label trial of autologous cytokine-induced killer cell immunotherapy plus chemotherapy for squamous non-small cell lung cancer
- Ren Xiubao (Tianjin, China)
- Ren Xiubao (Tianjin, China)
- Quanli Gao (Zhengzhou, China)
- Jingting Jiang (Changzhou, China)
- Junping Zhang (Taiyuan, China)
- Xin Song (Kunming, China)
- Liang 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
NCT01631357.
Legal entity responsible for the study
The authors.
Funding
The National Key Technologies R&D Program of China Grant Awards No. 2015BAI12B12 (to Xiubao Ren).
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant 24MO
- Andrew Furness (London, United Kingdom)
- Andrew Furness (London, United Kingdom)
A randomised, controlled, multicenter phase II trial of camrelizumab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant treatment in locally advanced NSCLC
- Jie Lei (Xi’an City, China)
- Jie Lei (Xi’an City, China)
- Xiaolong Yan (Xi’an City, China)
- Jinbo Zhao (Xi’an City, China)
- Feng Tian (Xi’an City, China)
- Qiang Lu (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.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant 62MO
- Benjamin Besse (Villejuif, France)
- Benjamin Besse (Villejuif, France)
Q&A and live discussion
- All Speakers (, United States of America)
- All Speakers (, United States of America)