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RATIONALE 304: Tislelizumab Plus Chemotherapy for Advanced Nonsquamous Lung Cancer

By: Justine Landin, PhD
Posted: Wednesday, September 8, 2021

Treatment with the anti–PD-1 antibody tislelizumab may benefit patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). A phase III trial (RATIONALE 304) conducted in China indicated that tislelizumab plus chemotherapy improved clinical outcomes for these patients compared with chemotherapy alone. The findings of this multicenter, open-label, randomized study were published in the Journal of Thoracic Oncology.

“Addition of tislelizumab to chemotherapy resulted in significantly prolonged progression free survival, higher response rates, and longer response duration compared with chemotherapy alone, identifying a new potential option for first-line treatment of advanced nonsquamous non–small cell lung cancer irrespective of disease stage,” stated Mengzhao Wang, MD, PhD, of Peking Union Medical College Hospital, Beijing, and colleagues.

Treatment-naive patients with stage IIIB or stage IV nonsquamous NSCLC without sensitizing EGFR mutations or ALK rearrangements were enrolled (n = 332). Patients were randomly assigned to receive either tislelizumab (200 mg) combined with platinum-based chemotherapy or chemotherapy alone. The choice of chemotherapy agent was determined according to each investigator’s discretion prior to study commencement.

At the median follow-up of 9.8 months, median progression free survival appeared to improve for patients who received tislelizumab plus chemotherapy (9.8 months) compared with chemotherapy alone (7.6 months, P = .004). In addition, response duration (8.5 months vs. 6.0 months), objective response rate (57.4% vs. 36.9%), and complete response rate (3.1% vs. 0.9%) were increased in the treatment group compared with the control group, respectively.

No new safety signals were identified. Adverse events of grade 1 or 2 were common in both groups. The majority of grade 3 or higher adverse events were associated with chemotherapy-induced neutropenia and leukopenia.

Disclosure: For full disclosures of the study authors, visit jto.org.



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