Novartis’ tislelizumab shows promising survival results in advanced esophageal cancer, Phase 3 data reveals

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.

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Novartis on Thursday announced the results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients.

“Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34% (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001).1 In collaboration with BeiGene, these data were presented today during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer (Abstract #LBA-1), the Pharma major revealed on Thursday.

“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. 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,” said Dr. Ken Kato, Chief of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan said.

“The prognosis for ESCC remains poor, with a five-year survival rate of just five percent, and patients are in need of more treatment options, especially in earlier lines of therapy. These results add to the growing body of evidence demonstrating the potential for tislelizumab to help patients with esophageal cancer, and reinforce our commitment to studying tislelizumab alone and in synergistic combinations across additional tumor types that may benefit from an immunotherapy,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis stated.

The company also revealed that the incidence of treatment-related adverse events (TRAEs) was similar in both arms. Most common TRAEs for tislelizumab plus chemotherapy versus chemotherapy were anemia (68% vs 61%), decreased neutrophils (78% vs 80%), decreased white blood cell count (55% vs 65%), decreased appetite (39% vs 38%), nausea (37% vs 42%) and peripheral sensory neuropathy (26% vs 21%), it stated.

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020. In the United States, it is estimated there will be more than 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers.

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