BeiGene, Novartis' tislelizumab report promising topline results in nasopharyngeal cancer

Chinese pharma company BeiGene and Novartis' PD-1 inhibitor tislelizumab, combined with chemotherapy, improved progression-free survival (PFS) when administered in the first-line setting for patients with metastatic nasopharyngeal cancer (NPC).

Topline results from the phase 3 RATIONALE 309 trial showed that tislelizumab plus chemotherapy achieved a statistically significant improvement in PFS at the interim analysis compared with chemotherapy alone.

Detailed results from the study will be presented at an upcoming medical conference, BeiGene said in a statement.

The study will continue to assess the key secondary endpoints of overall survival (OS), independent review committee (IRC) assessed objective response rate (ORR) and duration of response (DoR).

NPC is a squamous cell carcinoma arising from the epithelial cells of the nasopharynx, with an estimated 60,558 new cases of this cancer type in China in 2018 – accounting for 46.9% of the global incidence of NPC.

“We are excited to see a clinically meaningful improvement in progression-free survival in our phase 3 trial for tislelizumab plus chemotherapy in patients with NPC," said Yong (Ben) Ben, chief medical officer, immuno-oncology, BeiGene.

"This is our fifth positive phase 3 readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody. We are grateful for the patients and clinicians who participated in this trial and hopeful that they may have a new treatment option in the future," he added.

In April, BeiGene also unveiled results from a key global trial of tislelizumab in non-small cell lung cancer (NSCLC).

The phase 3 RATIONALE 303 study compared tislelizumab to chemotherapy medication docetaxel as second- or third-line therapy for patients with locally advanced or metastatic NSCLC.

In the interim analysis, the study achieved the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population, with a median OS of 17.2 months in the tislelizumab arm compared to 11.9 months in the docetaxel arm.

For patients with high PD-L1 expression, the median OS jumped to 19.1 months. Median progression-free survival (PFS) was found to be 4.1 months in the tislelizumab arm compared to 2.6 months in the docetaxel arm.

In January, Novartis and BeiGene signed a strategic collaboration agreement for the Swiss pharma company to in-license tislelizumab in ‘major markets’ outside China. As part of that agreement, Novartis gained development and commercialisation rights to tislelizumab in the US, Canada, Mexico, the EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan for an upfront payment of $650m, plus royalties and milestone payments.