Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

January 22, 2020
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Tislelizumab extends PFS in squamous non-small cell lung cancer

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A randomized phase 3 trial designed to evaluate the addition of tislelizumab to first-line chemotherapy for patients with squamous non-small cell lung cancer met its primary endpoint of PFS, according to results of an interim analysis 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-A317-307 trial included 360 patients from China with previously untreated stage IIIB or stage IV squamous NSCLC. Researchers enrolled patients regardless of PD-L1 expression.

Researchers randomly assigned patients 1:1:1 to tislelizumab dosed at 200 mg every 3 weeks plus paclitaxel and carboplatin; tislelizumab in combination with nab-paclitaxel (Abraxane, Celgene) and carboplatin; or paclitaxel and carboplatin alone.

Treatment continued until disease progression, unacceptable toxicity, consent withdrawal or physician decision.

Patients assigned chemotherapy only who experienced disease progression as verified by central independent review were allowed to cross over to tislelizumab monotherapy.

PFS as assessed by independent review committee served as the primary endpoint. Key secondary endpoints included OS and safety.

Results of a preplanned interim analysis showed both tislelizumab-chemotherapy regimens conferred a statistically significant PFS benefit compared with chemotherapy alone.

Tislelizumab exhibited a safety profile consistent with prior studies, and investigators identified no new safety signals.

Full data from the BGB-A317-307 trial will be submitted for presentation at an upcoming medical meeting.

Tislelizumab is approved in China for treatment of patients with relapsed or refractory classical Hodgkin lymphoma. The agent is not approved in any other country.

BeiGene’s development program for the drug consists of 25 studies — including three other phase 3 studies in lung cancer — with more than 5,000 patients.