In recent times, several big pharma have collaborated with small companies in the immuno-oncology field. Last September, Pfizer made a $200 million investment to collaborate with CStone Pharmaceuticals. Now Novartis has found a collaborator in BeiGene to remain competitive against other top-selling drugs such as Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo.
Novartis, BeiGene Collaboration
On January 11th, Novartis signed a strategic collaboration agreement to in-license tislelizumab from BeiGene in major markets outside of China, fortifying Novartis’ immuno-oncology pipeline and checkpoint inhibitor field. Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the U.S., Canada, Mexico, the European Union, U.K., Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of $650 million.
BeiGene will be eligible to receive up to $1.55 billion in potential regulatory and sales milestone payments plus royalties on product sales. BeiGene will still retain the rights to tislelizumab in China and other countries.
“Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders. This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, 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,” said Susanne Schaffert, PhD, President, Novartis Oncology. “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.”
“We are excited to collaborate with Novartis to further explore the potential of tislelizumab in multiple combinations and indications. Novartis is a well-recognized leader in oncology with a unique portfolio of cancer treatments and pipeline agents,” said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene.
“This important collaboration stands on a strong foundation of tislelizumab’s broad global development program, which has delivered two approvals in China, currently spans 15 potentially registration-enabling clinical trials, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside of mainland China. We look forward to working with Novartis to fulfill the global opportunity of this potentially differentiated anti-PD-1 antibody.”
The Success of Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, specifically reducing the binding to FcγR on macrophages. According to pre-clinical studies, the binding compromises the anti-tumor activity of PD-1 antibodies. Tislelizumab has successfully entered several Phase 3 trials that examined its efficacy in patients with relapsed/refractory classical Hodgkin Lymphoma, metastatic urothelial carcinoma, NSCLC, etc.
Tislelizumab has been approved by the China National Medical Products Administration (NMPA) for two indications, classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review.
These indications are first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.
Novartis’ Uphill Fight in PD-1 Inhibitors
Novartis’ own PD-1 inhibitor spartalizumab failed a Phase 3 first-line melanoma trial when combined with its BRAF-MEK inhibitor duo Tafinlar and Mekinist last Fall. This delayed Novartis’ entry into the PD-1 race. However, the company remains committed to its PD-1 combo strategy and to spartalizumab.
According to Novartis’ spokesperson, “our late-stage development plan for spartalizumab historically has focused on combination regimens in a limited number of indications where anti-PD-1 therapy has not yet been established as standard of care.”
“BeiGene’s development plan for tislelizumab has focused on a broader set of indications as monotherapy or in combination with standard-of-care chemotherapy, such as in lung cancer,” he added. In other words, the limited number of indications for spartalizumab requires more effort to explore and construct its standard-of-care than the broad indications for tislelizumab, where it could use what has already been established in similar therapeutic conditions.
By Judy Ya-Hsuan Lin
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