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JCSE01 - Joint IASLC-CSCO-CAALC Session (ID 63)
- Event: WCLC 2019
- Type: Joint IASLC-CSCO-CAALC Session
- Presentations: 1
- Now Available
- Moderators:Chunxue Bai, Tony Mok, Yi-Long Wu, Qing Zhou, Nan Wu
- Coordinates: 9/07/2019, 07:00 - 11:15, Toronto (1985)
JCSE01.10 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (Now Available) (ID 3424)
07:00 - 11:15 | Author(s): Fan Zhang
NSCLC patients who have potentially resectable disease often subsequently relapse after surgery. New therapy that prevents relapse after surgery is desperately needed. In this study, we tested the efficacy and safety of neoadjuvant sintilimab, an anti-PD-1 antibody, for patients with resectable sqNSCLC in China.
All patients had treatment-naïve resectable sqNSCLC (stage IB-IIIA) that was confirmed by histopathology. Patients received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. An enhanced PET/CT was obtained at baseline and seven days prior to surgery. Preliminary analysis of safety profile and efficacy was planned after at least 20 patients had received operation.
As of Jan. 28, 2019, 22 patients (20 males and 2 females) with sqNSCLC received two doses of sintilimab followed by radical resection. The median age was 61.5 yr (range, 48 to 70). Six (27.3%) and four (18.2%) patients experienced neoadjuvant treatment emergent adverse events (TEAEs) and neoadjuvant treatment-related AEs (TRAEs), respectively. Most of the TEAEs and TRAEs were grade 1 or 2. Three patients achieved radiological partial response: an ORR of 13.6% based on RECIST 1.1. Ten patients (45.5%) achieved a major pathologic response (MPR, ≤10% viable tumor cells), including four (18.2%) had complete pathologic response (no viable tumor cell). There was a direct correlation between pathological response and decrease in the standardized uptake values (SUV) in the primary tumor. Among nine patients with > 30% decrease of SUV, eight had MPR, compared with no MRP response in the 11 patients with ≤30% decrease of SUV.
Neoadjuvant sintilimab for sqNSCLC patients was tolerable and the 45.5% MRP rate is encouraging. A decrease in SUV may be predictive of pathologic response after PD-1 therapy in sqNSCLC.
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P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
P1.18-06 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (ID 2999)
09:45 - 18:00 | Author(s): Fan Zhang
Non-small cell lung cancer (NSCLC) patients with potentially resectable disease most would experience relapse after surgery. New strategy preventing recurrence is in urgent need. In the current study, we first evaluated the safety and efficacy of neoadjuvant sintilimab in Chinese patients with resectable NSCLC.Method
Patients with treatment-naïve resectable NSCLC (stage IB-IIIA) received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. The tumor imaginations were obtained at baseline and within seven days prior to surgery. The primary endpoint was safety, and efficacy endpoints include disease free survival, rate of major pathologic response (MPR, ≤10% viable tumor cells) and objective response rate (ORR). Expression of programmed death ligand 1 (PD-L1) in baseline biopsy tissues and surgical samples were investigated. (Registration Number: ChiCTR-OIC-17013726).Result
A total of 40 patients with NSCLC were enrolled, among which 32 (80%) were male; 33 (82.5%) had squamous-cell carcinoma; 35 (87.5%) had stage IIA to IIIB disease; and 33 (82.5%) were former or current smokers. As of June 15th, 2019, all of the patients received 2 doses of sintilimab, and 37 patients underwent radical resection. Among 40 patients, 18 (45%) patients experienced neoadjuvant treatment-related adverse events (TRAEs). Two (5%) patient experienced grade 3-4 neoadjuvant TRAE. One treatment related surgery delay was reported because of grade 1 hyperthyroidism. None of the patients has confirmed recurrence to date. Among 37 patients, 8 patients achieved radiological partial response (PR), resulted in an ORR of 21.6% regarding RECIST 1.1. Fifteen (40.5%) patients achieved MPR, and 6 (16.2%) patients had complete pathologic response (cPR) (Figure 1). There’s no correlation between baseline characteristics and MPR (Table 1). Maximum standardized uptake values (SUVmax) reduction of primary tumor after sintilimab treatment was significantly corelated with pathological response (correlation coefficient = 0.86, p <0.00001). However, there was no significant correlation between decrease in sum of lesion diameter (SLD) and pathological response (correlation coefficient = 0.21, p = 0.2104). Squamous cell carcinoma showed a better MPR (15/33, 45.5%) compared with adenocarcinoma (0/6 0%). Baseline PD-L1 expression of stromal cells was correlated with pathological regression (p= 0.0471). In 18 patients with post-surgery pathologically positive lymph nodes, heterogeneity of response between primary tumor and lymph nodes were found by comparing MPR, change of SUVmax and SLD.Conclusion
Neoadjuvant sintilimab for Chinese NSCLC patients was well tolerated and the 40.5% MRP rate is encouraging. A SUVmax reduction may be more predictive of pathologic response than decrease in SLD after neoadjuvant PD-1 therapy in NSCLC. Heterogeneity exists between primary tumor and lymph nodes.