November 17, 2020 - The PD-1 inhibitor tislelizumab was found to improve overall survival versus docetaxel in the second- or third-line treatment in patients with locally advanced or metastatic non–small cell lung cancer who progressed on previous platinum-based chemotherapy.
The PD-1 inhibitor tislelizumab (BGB-A317) was found to improve overall survival (OS) versus docetaxel in the second- or third-line treatment in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who progressed on previous platinum-based chemotherapy, meeting the primary end point of the phase 3 RATIONALE-303 trial (NCT03358875).1
Moreover, additional results from the interim analysis indicated that tislelizumab was safe, with no new signals reported, according to BeiGene, Ltd.
“The RATIONALE 303 is the third phase 3 trial of tislelizumab in NSCLC that has achieved a positive outcome at interim analysis, and more importantly, marks the first global pivotal trial with a positive outcome in the tislelizumab clinical program, demonstrating BeiGene’s capabilities in global clinical development,” Yong (Ben) Ben, MD, chief medical officer of Immuno-Oncology at BeiGene, stated in a press release. “We look forward to sharing the full results at an upcoming medical conference and providing additional updates on our lung cancer program in the future.”
In the randomized, open-label, multicenter phase 3 trial, investigators set out to examine the safety and efficacy of tislelizumab versus docetaxel as second- or third-line treatment in patients with locally advanced or metastatic NSCLC who experienced disease progression following previous platinum-based chemotherapy.
To be eligible for participation, patients had to be 18 years of age, be able to provide fresh or archival tumor tissue samples for PD-L1 evaluation, have an ECOG performance status of 0 or 1, acceptable hematologic and end-organ function, and a life expectancy of over 12 weeks.2
If they received previous treatment with docetaxel or a PD-1, PD-L1, or CTLA-4 inhibitor, they were excluded from the analysis. Moreover, patients whose tumors harbored EGFR or ALK aberrations, those who had a history of severe hypersensitivity reactions to other monoclonal antibodies, or a history of interstitial lung disease could not participate.
A total of 805 patients were randomized in a 2:1 fashion to receive either tislelizumab or docetaxel. Patients on the experimental arm of the trial received intravenous (IV) tislelizumab at a dose of 200 mg every 3 weeks, while those in the control arm received IV docetaxel at a dose of 75 mg/m2 every 3 weeks.
The primary end point of the trial is OS in the ITT population and in patients with a high PD-L1 expression. Secondary end points comprised objective response rate, duration of response, progression-free survival, and safety.
“As we continue to advance tislelizumab in its broad clinical program, which targets a wide range of prevalent cancer types, we expect to see a growing body of clinical evidence that we believe will help further evaluate this potentially differentiated checkpoint inhibitor and support potential regulatory filings in China and globally,” Ben added in the release.