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Novartis announces tislelizumab helped extend median overall survival in first-line advanced esophageal cancer 

By Brian Buntz | June 30, 2022

Novartis in the Pharma 50Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study.

The survival benefits were seen in patients regardless of PD-L1 status.

The benefits were consistent across patient subgroups in the study.

In the study, the combination of tislelizumab and chemotherapy resulted in median overall survival of 17.2 months compared to 10.6 months in patients receiving chemotherapy plus placebo.

Investigators concluded that the combination of chemotherapy and tislelizumab cut the risk of death by 34%.

Tislelizumab was first developed by BeiGene. Novartis paid $650 million for rights to the drug. The company also stands to pay up to $1.55 billion in potential milestone payments.

Novartis developed its own PD-1 inhibitor, spartalizumab. In 2020, spartalizumab did not meet its primary endpoint of investigator-assessed progression-free survival in the Phase 3 COMBI-i in advanced melanoma. The study tested using spartalizumab in tandem with Tafinlar (dabrafenib) and Mekinist (trametinib).

“These data, which show tislelizumab plus chemotherapy extended patients’ lives by a median of more than six months, are a promising outcome in the treatment of this aggressive cancer,” said Dr. Ken Kato, chief of head and neck medical oncology, National Cancer Center Hospital, Tokyo, Japan, in a statement. “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.”

Regulators in the U.S. and Europe are reviewing tislelizumab for advanced or metastatic ESCC after prior chemotherapy.

Novartis announced that the RATIONALE 306 study is the seventh positive Phase 3 study readout for tislelizumab.

Tislelizumab has been the subject of more than 200 clinical studies to date.


Filed Under: Oncology
Tagged With: chemotherapy, Novartis, RATIONALE 306, tislelizumab
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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