Abstract 138P
Background
Interim analysis of the open-label phase 3 RATIONALE-304 study (NCT03663205) demonstrated clinical benefit of tislelizumab (TIS) plus chemotherapy (chemo) as first-line (1L) therapy in patients with advanced nsq-NSCLC vs chemo alone, with significantly improved progression-free survival (PFS) and a manageable safety profile. Here, we report the updated results.
Methods
Adults with treatment-naive, stage IIIB (not amenable to curative surgery/radiotherapy)/IV nsq-NSCLC were randomized (2:1) to receive platinum (carboplatin or cisplatin) and pemetrexed (PEM) every 3 weeks either with TIS (Arm A) or without (Arm B), followed by maintenance TIS + PEM (Arm A) or PEM (Arm B). The primary endpoint was PFS in Arm A vs Arm B, per independent review committee (IRC). Secondary endpoints included overall survival, objective response rate (ORR), duration of response (DoR), and safety.
Results
As of 15 July 2022, the median PFS per IRC was 9.8 (95% confidence interval [CI]: 8.9, 11.7) vs 7.6 (95% CI: 5.4, 8.0) months (mo) in Arm A vs Arm B, respectively (stratified hazard ratio 0.61 [95% CI: 0.46, 0.82]). ORR was greater in Arm A (51.6% [95% CI: 44.8, 58.3]) vs Arm B (27.9% [95% CI: 19.8, 37.2]) and median DoR was longer (14.5 [95% CI: 10.1, 24.4] vs 8.4 [95% CI: 6.0, 15.5] mo, respectively). TIS plus chemo was tolerable with no new safety signals identified after longer follow-up. The incidences of ≥grade 3 treatment-emergent adverse events (TEAEs) and of TEAEs leading to death (including disease progression-related AEs) in Arm A and Arm B were 69.4% and 56.4%, and 4.1% and 1.8%, respectively.
Conclusions
In RATIONALE-304, the addition of TIS to platinum plus PEM continued to demonstrate favorable efficacy and was generally well tolerated as 1L treatment of advanced nsq-NSCLC vs chemo alone, with no new safety signals identified.
Clinical trial identification
NCT03663205.
Editorial acknowledgement
This study was sponsored by BeiGene, Ltd. Medical writing support, under the direction of the authors, was provided by Arezou Hossein, MPharm, of Ashfield MedComms, an Inizio company, and was funded by BeiGene, Ltd.
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
S. Lu: Financial Interests, Personal, Other, Research support: AstraZeneca, Hutchison, BMS, Heng Rui Beigene and Roche, Hansoh ; Financial Interests, Personal, Other, Speaker fees: AstraZeneca, Roche, Hansoh; Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Hutchison MediPharma, ZaiLab, GenomiCare, Novarti, Yuhan Corporation, Menarini, Mirati Therapeutics Inc, and Roche. W. He, Y. Bao: Financial Interests, Personal, Full or part-time Employment: BeiGene, Ltd. All other authors have declared no conflicts of interest.