Novartis Adds BeiGene's Checkpoint Inhibitor to Oncology Arsenal

Susanne Schaffert, president of Novartis Oncology, pictured above. Photo courtesy of Novartis.

Novartis has forged a licensing agreement with China’s BeiGene to expand its oncology offerings and dive into anti-PD-1 therapies. The deal adds a late-stage checkpoint inhibitor under investigation as a monotherapy, as well as potential PD-1 combinations. The deal is expected to drive long-term growth for the Swiss pharma giant.

Novartis plunked down $650 million in upfront payment for BeiGene’s Tislelizumab, which is already approved for patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma in China. The checkpoint inhibitor is also involved in 15 different registration-enabling trials in non-small cell lung cancer and other solid tumors, including hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma, Novartis said.

Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors.

BeiGene has already filed three supplemental New Drug Applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC, Novartis said.

Under terms of the deal, Novartis will have development and commercialization rights in North America, Europe and Japan. BeiGene retains the rights to tislelizumab in China and other countries. BeiGene is eligible for additional milestone payments, which could bring the total investment from Novartis past the $1.5 billion mark, analysts suggest. Novartis expects the first regulatory filing for tislelizumab outside of China to occur later this year.

Susanne Schaffert, president of Novartis Oncology, said the agreement with BeiGene expands the company’s strategy of pursuing four separate approached to treating cancer. The company’s strategies are radioligand therapy, cell and gene therapy and immunotherapy.

“No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient,” Schaffert said in a statement. “Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders… 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.”

During a presentation at the 2021 J.P. Morgan Healthcare Conference on Monday, Novartis Chief Executive Officer Vas Narasimhan pointed to the number of transactions Novartis has made over the past two years to become a balanced, medicines-focused company.

“… in order to execute that journey, we've done over 80 major transactions and partnerships,” he said, according to a transcript of the presentation. “We have over 15 blockbusters in our portfolio, and we have exposure to all of the major advanced therapy platform that we believe that will shape our industry in the decades to come; cell therapy, gene therapy, radioligand, therapy, and of course, RNA technologies.”

Novartis isn’t the only western company to turn to China for checkpoint inhibitors. Last year, Pfizer took a 10% stake in CStone Pharmaceuticals to gain access to sugemalimab (CS1001), a PD-L1 antibody. CStone has been developing sugemalimab for high-incidence cancer indications in China, including lung, gastric and esophageal cancers.