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Novartis announces positive phase 3 trial results for advanced oesophageal cancer

Results from the study showed tislelizumab plus chemotherapy significantly improved overall survival for patients, regardless of PD-L1 status


Novartis has announced positive results from a phase 3 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) for patients with advanced oesophageal cancer, regardless of PD-L1 status.

Results from the RATIONALE 306 study showed tislelizumab plus chemotherapy reduced the risk of death by 34%, with the treatment demonstrating a median OS of 17.2 months, compared to 10.6 months in patients receiving chemotherapy plus a placebo.

The double-blind study included 649 patients with unresectable, locally advanced recurrent or metastatic oesophageal squamous cell carcinoma. As well as PD-L1 status, survival benefit was consistent across all other subgroups, including race, geographical region and investigator choice of chemotherapy.

Dr Ken Kato, chief of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, said: “This data, which shows tislelizumab plus chemotherapy extended patients’ lives by a median of more than six months, is a promising outcome in the treatment of this aggressive cancer.

“Importantly, the significant overall survival benefit was observed across all patient subgroups in the trial, indicating that tislelizumab plus chemotherapy may be a viable treatment option for patients regardless of their PD-L1 score.”

Tislelizumab is a humanised immunoglobulin G4 monoclonal antibody designed to minimise binding to Fc gamma receptors on macrophages, which may result in anti-PD-1 resistance.

The treatment is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed oesophageal cancer, with the FDA due to deliver its verdict by 12 July.

The EMA is also reviewing the drug for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.

BeiGene, tislelizumab’s original developer, has already secured approval for the PD-1 inhibitor in China for the treatment of non-small cell lung cancer (NSCLC), classical Hodgkin lymphoma, liver cancer hepatocellular carcinoma (HCC) and PD-L1-high urothelial carcinoma.

Through a collaboration and licence agreement with BeiGene, Novartis has the rights to develop, manufacture and commercialise tislelizumab in North America, Europe and Japan.

“These results add to the growing body of evidence demonstrating the potential for tislelizumab to help patients with oesophageal cancer, and reinforce our commitment to studying tislelizumab alone and in synergistic combinations across additional tumour types that may benefit from an immunotherapy,” said Jeff Legos, executive vice president, global head of Oncology and Hematology Development, Novartis.

Article by
Emily Kimber

4th July 2022

From: Research, Healthcare



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