Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

April 14, 2020
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Tislelizumab-chemotherapy combination extends PFS in non-small cell lung cancer

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The addition of tislelizumab to first-line chemotherapy extended PFS among patients with nonsquamous non-small cell lung cancer, according to topline data from a randomized phase 3 trial released by the agent’s manufacturer.

Tislelizumab (BGB-A317, BeiGene) is humanized immunoglobulin G4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc gamma receptors on macrophages.

The open-label, multicenter BGB-A317-304 trial included 334 patients with previously untreated stage IIIB or stage IV nonsquamous NSCLC who had no EGFR or ALK translocations. Researchers assigned patients 2:1 to tislelizumab dosed at 200 mg every 3 weeks combined with chemotherapy or chemotherapy alone. Chemotherapy consisted of pemetrexed and investigator’s choice of platinum (either carboplatin or cisplatin).

The trial met its primary endpoint — PFS as assessed by independent review committee — at the planned interim analysis.

The combination of tislelizumab and chemotherapy exhibited a safety profile consistent with the known profiles of each agent. Investigators observed no new safety signals.

“These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers,” Yong (Ben) Ben, MD, chief medical officer for immuno-oncology at BeiGene, said in a company-issued press release. “We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials.”

As Healio previously reported, results of a separate randomized phase 3 trial released earlier this year showed the addition of tislelizumab to first-line chemotherapy extended PFS among patients with squamous NSCLC.