Neoadjuvant Tislelizumab (TIS) Plus Chemotherapy (CT) with Adjuvant TIS vs. Neoadjuvant Placebo(PBO) Plus CT with Adjuvant PBO in Resectable Non-Small Cell Lung Cancer (NSCLC): PatientReported Outcomes (PRO) in the RATIONALE-315 TrialAuthors and Affiliations: Federico Cappuzzo1*, Changli Wang2, Wenxiang Wang3, Hongxu Liu4, Qixun
Chen5, Dongsheng Yue2, Shengfei Wang6, Bin Yao7, Bryant Barnes8, Gisoo Barnes8*Presenting Author
1Istituto Nazionale Tumori IRCCS Regina Elena, Rome, Italy
2Department of Lung Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China;
3The Second Department of Thoracic Surgery, Hunan Cancer Hospital, Hunan, China;
4Department of Thoracic Surgery, Liaoning Cancer Hospital and Institute, Shenyang, China;
5Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China;
6BeiGene (Shanghai) Co., Ltd., Shanghai, China;
7BeiGene (Beijing) Co., Ltd, Beijing, China;
8BeiGene USA, Inc., San Mateo, CA, USA.

Background: In the pivotal phase 3 RATIONALE-315 trial (NCT04379635) of patients with resectablestage II to IIIA NSCLC, perioperative TIS plus (+) neoadjuvant platinum-based CT led to a significant
improvement in event-free survival [HR=0.56, p=0.0003] compared to placebo + neoadjuvant platinumbased CT. Here, we report results for PRO instruments from RATIONALE-315.
Methods: PROs were secondary endpoints assessed using the EORTC QLQ-C30 and QLQ-LC13
instruments. Key PRO endpoints included QLQ-C30 GHS/QoL, physical function, as well as QLQ-LC13
symptoms of dyspnea, cough, and chest pain. A mixed model for repeated measures was performed atCycle 1 (baseline), Cycle 3 of neoadjuvant phase, the Cycles 3 and 7 of adjuvant phase. Time todeterioration (TTD) was examined using Kaplan-Meier method. All HRQoL analysis were performed on theintent-to-treat analysis set.
Results: A total of 453 pts were randomized (1:1) to receive neoadjuvant TIS (n=226) or PBO (n=227). By
Cycle 7, no meaningful differences in least-squares (LS) mean change from baseline between arms wereobserved for GHS/QoL, physical functioning, and fatigue, or chest pain and dyspnea (Table); however, theTIS + CT arm experienced a meaningful improvement in LS mean for coughing (-4.37 [95% CI: -9.46 to0.21]). TTD analysis showed that pts in the TIS + CT arm were at lower risk of worsening for chest pain
(HR 0.59 [95% CI: 0.38-0.91]); risk of worsening was similar between the arms in all other PRO endpoints.
Conclusions: Pts in the TIS + chemo arm experienced better HRQoL outcomes than those in the PBO +CT arm in this population of patients with resectable NSCLC, with improvements in coughing and lower riskof chest pain
Table

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1

Least Squares Mean (95% CI)
HRQoL
endpoint

Cycle 3: adjuvant phase

Cycle 7: adjuvant phase

TISPBO

TIS

PBO

-1.14
(-3.79, 1.52)-3.57(-5.10, -2.05)
2.52(0.23, 4.81)-1.97(-4.77, 0.83)-3.61(-5.22, -2.01)
2.97(0.57, 5.37)

1.09(-1.34, 3.53)-2.60(-4.20, 1.00)
2.54(0.09, 4.99

1.90(-0.66, 4.46)-2.23(-3.92, -0.54)
2.87(0.30, 5.45)-4.58(-7.75, -1.42)
0.43(-2.42, 3.28)
4.62(2.57, 6.67)-5.63(-8.97, -2.29)
5.42(2.39, 8.44)
6.57(4.41, 8.74)-12.15(-15.60, -8.71)
0.36(-2.34, 3.05)
3.18(0.82, 5.55)-7.52(-11.16, -3.89)
1.89(-0.96, 4.75)
4.56(2.07, 7.06)

QLQ-C30
GHS/QoL
Physicalfunctioning
Fatigue
QLQ-LC13
Coughing
Chest pain
Dyspnea

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