BeiGene’s Tislelizumab Improves Survival in Esophageal Cancer Study

BeiGene_ Ji Haixin/VCG via Getty Images

 Ji Haixin/VCG via Getty Images

BeiGene continues its roll with anti-PD-1 monoclonal antibody tislelizumab, announcing topline data yesterday from its fourth positive Phase III trial, this time in esophageal squamous cell carcinoma (ESCC).

Tislelizumab met its primary endpoint of improving overall survival, compared with chemotherapy, in the RATIONALE 302 trial of 512 advanced unresectable or metastatic ESCC patients who previously received a systemic treatment.

This caps a month that already saw positive interim Phase III data for tislelizumab in squamous non-small cell lung cancer (NSCLC), in combination with two chemotherapeutics, and tislelizumab’s first full approval in China, as a first-line therapy for advanced squamous NSCLS in combination with chemotherapy.

Tislelizumab, a checkpoint inhibitor, also has conditional approvals in China for Hodgkin’s lymphoma and urothelial carcinoma but has not been approved anywhere else. Beijing- and Cambridge, Mass.-based BeiGene also inked a new deal with Novartis worth $650 million up front to develop and commercialize tislelizumab in North America, Europe, Japan and Russia.

The latest Phase III results tested tislelizumab against the investigator’s choice of paclitaxel, docetaxel or irinotecan. Although the U.S. Food and Drug Administration (FDA) has approved two immunotherapies in the indication – Bristol Myers Squibb’s Opdivo and Merck & Co.'s Keytruda – the standard of care to date is still chemotherapy.

“Recent years have seen a paradigm-shift in advanced ESCC treatment from chemotherapy and radiation to immunotherapy,” said lead investigator Lin Shen, VP of clinical oncology at Beijing Cancer Hospital. She added that the new data raised hope tislelizumab could be a new treatment option in esophageal cancer, an area with “significant unmet medical need with rapid progression and high mortality.”

According to BeiGene, the disease kills about 550,000 patients per year, in part because it is typically advanced or metastatic when it is diagnosed. Median survival time is under 10 months.

BeiGene has not yet disclosed detailed data yet, but said improvements to overall survival were statistically significant and “clinically meaningful.” The company said it plans to disclose more data at an upcoming medical conference.

Aside from the ESCC and squamous NSCLC trials reporting data recently, BeiGene is sponsoring at least 14 additional Phase III or pivotal Phase II trials that could potentially lead to registration for tislelizumab. Those trials for the immunotherapy, alone or in combination with chemotherapies, are in lymphoma and solid tumors including urothelial cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, nasopharyngeal cancer and several lung cancers.

Approvals in those areas would set up tislelizumab to challenge Keytruda, which has so far been approved in 26 solid and liquid cancers.

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