Novartis Signs In-Licensing Agreement With BeiGene to Expand Tislelizumab Trials Globally

Susanne Schaffert, PhD

Novartis has signed a strategic collaboration agreement to in-license the PD-1 inhibitor tislelizumab (BGB-A317) from BeiGene, Ltd, in various markets outside of China, according to a news release from the pharmaceutical company.¹

The agreement, in which Novartis will pay BeiGene an up-front cash payment of $650 million plus royalties, allows Novartis to develop and market tislelizumab in the United States, Canada, Mexico, the European Union, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. The agreement is also eligible for payment up to $1.3 billion based on regulatory indications and up to $250 based on sales targets.² Notably, BeiGene will retain its rights to the checkpoint inhibitor in China and other countries.

“Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders,” said Susanne Schaffert, PhD, president of Novartis Oncology.¹ “This agreement expands on our strategy as the only company pursuing 4 different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy.”

“We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients,” added Schaffert.

Tislelizumab is an anti–PD-1 monoclonal antibody that directly effects FcγR binding on macrophages.³ The agent is designed to minimize FcγR binding on macrophages, which has been shown to decrease the anti-tumor effectiveness of PD-1 antibodies through activation of antibody-dependent macrophage-mediating killing of T-effector cells.

The agent was initially approved in December 2019 by the China National Medical Products Administration (NMPA) for the treatment of patients with classical Hodgkin lymphoma. In April 2020, the NMPA also approved tislelizumab as treatment for patients with PD-L1–high, previously treated advanced or metastatic urothelial carcinoma.

On January 14, 2021, the NMPA approved tislelizumab for use in combination with 2 chemotherapy regimens for the frontline treatment of patients with advanced squamous non–small cell lung cancer (NSCLC).⁴ The regulatory decision was based on findings from the phase 3 BGB-A317-307 trial in which frontline tislelizumab plus chemotherapy improved progression-free survival (PFS) versus chemotherapy alone among Chinese patients with advanced squamous NSCLC.⁵

Additionally, 2 supplemental biologics license applications are outstanding for tislelizumab in China. One is for the agent in combination with chemotherapy for the frontline treatment of patients with nonsquamous NSCLC, and the other is for patients with previously treated, unresectable hepatocellular carcinoma (HCC).

Over a dozen potentially registration-enabled clinical trials are ongoing in China, evaluating tislelizumab in various indications across oncology. Thousands of patients with NSCLC, HCC, esophageal squamous cell carcinoma, gastric cancer, and nasopharyngeal carcinoma will undergo treatment with tislelizumab. Notably, BeiGene and Novartis have identified multiple opportunities to combine the checkpoint inhibitor with therapies developed by Novartis in solid malignancies.

Under the Hart-Scott-Rodino Antitrust Improvements Act, the transaction closing is subject to expiration or early termination of the waiting period.

References

1. Novartis expands oncology pipeline with in-licensing of tislelizumab from BeiGene. News release. Novartis. January 11, 2021. Accessed January 25, 2021. http://bit.ly/36dxfZB.

2. Novartis pays $650 million upfront for rights to BeiGene’s anti-PD-1 drug tislelizumab. New release. FirstWord Pharma. January 11, 2021. Accessed January 25, 2021. http://bit.ly/3iIZh4n

3. Science and pipeline: tislelizumab. Beigene. 2021. Accessed January 25, 2021. http://bit.ly/3pgkZis

4. China National Medical Products Administration approves tislelizumab in combination with chemotherapy in first-line advanced squamous non-small cell lung cancer. News release. BeiGene, Ltd. January 13, 2021. Accessed January 25, 2021. http://bwnews.pr/3qpPOBF

5. Wang J, Yu X, Lu S, et al. Phase III study of tislelizumab plus chemotherapy vs chemotherapy alone as first-line (1L) treatment for advanced squamous non-small cell lung cancer (sq NSCLC). J Clin Oncol. 2020;28(suppl 15):9554. doi:10.1200/JCO.2020.38.15_suppl.9554