With tislelizumab, BeiGene brings immunotherapy to more patients in Europe

This executive interview, sponsored by BeiGene (Nasdaq: ONC; HKEX: 06160; SSE: 688235), is with Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene.

Almost every week brings news on the progress of tislelizumab, BeiGene’s (Nasdaq: BGNE) uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1.

Through its efficient in-house clinical development, unwavering commitment to patient access, and affordability of medicines, BeiGene is bringing swift global access to tislelizumab. This medicine is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping the body’s immune cells detect, remain active longer and better fight tumors, while maintaining a positive benefit-risk ratio.

In November, BeiGene gained European Commission approval for tislelizumab as a first-line treatment for eligible patients with advanced/metastatic gastric or gastroesophageal junction (G/GEJ) cancer and esophageal squamous cell carcinoma (ESCC) whose tumors express with PD-L1 with a tumor area positivity score ≥ 5%.

Tislelizumab has already been approved and launched in the European Union for eligible patients with advanced or metastatic ESCC after prior platinum-based chemotherapy and for both first- and second-line non-small cell lung cancer (NSCLC). Approval has been granted in the UK and Switzerland, too, with the medicine available for eligible patients in Switzerland in second-line ESCC since November 2024.

Approval was also granted by the US Food and Drug Administration (FDA) as a monotherapy in adults with unresectable or metastatic ESCC following prior systemic chemotherapy and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers in the USA, where it was made available for commercial sale in October 2024 with a price 10% lower than other anti-PD-1 therapies approved in this indication.

‘Substantial unmet need’

Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene, expressed the importance of access to tislelizumab for European patients.

“The introduction of PD-1 inhibitors revolutionized the treatment of many types of solid tumors. However, there remains a substantial unmet need, with inconsistent access to immunotherapy across disease areas and geographies, even in Europe,” Dr Terwey said.

“With tislelizumab, we’re aiming to close a gap in access to the right type of immunotherapy care in line with our mission to deliver impactful treatments to cancer patients throughout the world.”

“This is obviously not the first PD-1 inhibitor launched in the European market—there are other products of the same class available,” he said. “But when we look at the types of cancers we are targeting with tislelizumab – lung cancer, esophageal cancer and gastric cancer – there is a real opportunity to help these patients considering the survival rates in these settings.”

Indeed, among patients with locally advanced non-small cell lung cancer the average five-year survival rate is only 35%, and this drops to only 7% for advanced/metastatic disease. Esophageal cancer is a rapidly fatal disease with a median survival of 8-10 months for those patients with advanced or metastatic disease, and gastric cancer is one of the five leading causes of cancer death.

The introduction of tislelizumab will offer another and—in many cases—a more affordable treatment option.

‘We are confident about the value of tislelizumab’

Tislelizumab has been studied in BeiGene's largest clinical trial program, involving almost 14,000 patients across 66 trials. This research, including 20 potentially registration-enabling studies in more than 34 countries, has consistently shown a positive benefit-risk ratio across the range of tumor types studied.

“We have robust data from pivotal studies in lung, gastric, and esophageal cancer that is very consistent with what you expect this class of medicine to do. Importantly, the safety profile for tislelizumab in combination with chemotherapy was manageable and in line with that of other anti-PD-1 antibodies,” Dr Terwey said. “That makes us confident about the value of tislelizumab for European patients.”

According to the EMA Summary of Product Characteristics for tislelizumab, the medicine’s safety profile is in line with that of other PD-1 inhibitors with risks indicated on immune-related adverse reactions and infusion-related reactions. The most common serious (grade three or four) adverse reactions for tislelizumab as a monotherapy were anemia (5.0%) and pneumonia (4.2%).

What is also noteworthy about tislelizumab is that BeiGene only regained the rights to the drug from Swiss pharma giant Novartis in September 2023, when the companies mutually agreed to end a collaboration and license agreement signed in 2021.

“It's remarkable how far we’ve come in that short period of time,” Dr Terwey said. “We now have approvals with all three European legislators, the European Commission, Swissmedic and the UK’s Medicines and Healthcare products Regulatory Agency, and we’ve already achieved reimbursement and launch in some European countries. This demonstrates our commitment and ability to deliver our medicines swiftly and with broad access.”

“In Norway, Austria, Germany and Switzerland, the first patients are being treated now, less than one year after we regained the rights. In many aspects, that's lightning speed.”

‘Building on zanubrutinib’s success’

Fortunately, BeiGene has prior experience with how to bring a new oncology treatment to patients in Europe, with its BTK inhibitor zanubrutinib receiving its first EMA authorization in 2021, and now reimbursed and available to eligible patients in 25 European countries.

“In terms of gaining access and reimbursement for tislelizumab, our goal is to handle the situation the way we did with zanubrutinib – by working with health systems and prioritizing speed to access – and I’m convinced we will be just as successful,” Dr Terwey said.

The company is also motivated to ensure access for those who have not previously benefited from comparable treatments.

“In Europe, there is access to PD-1 inhibitors generally, but it can also be very inequitable, depending on the country and disease area,” Dr Terwey said.

“We are striving to reach these underserved markets and indications so that access to this revolutionary type of therapy becomes more equitable across Europe.”

Despite being a young company founded in 2010, BeiGene boasts some remarkable statistics to show its rapid rise to becoming an oncology leader—the result of intentional investment by the company in building up research and development capabilities that has handsomely paid off.

‘A company built differently’

BeiGene has launched more than 140 clinical trials across some 45 countries, involving more than 24,000 patients. Its internally developed medicines have been approved in 70+ markets, and it has almost 11,000 global employees, including more than 1,100 oncology researchers. Europe represents a major footprint in BeiGene's clinical development, with over 3,500 patients enrolled across 50+ trials in 30 European countries.

“When I look at the number and promise of the assets in the pipeline, I’m always impressed with the productivity and opportunity that this represents,” Dr Terwey said.

“At this moment, BeiGene is among the top five oncology companies in terms of the number of New Molecular Entities going into the clinic in solid tumors and hematologic malignancies. We now have over 30 clinical or commercial stage molecules and over 60 preclinical development programs. The productivity of our discovery research organization is on par with the big players in oncology and hematology.”

“How is this possible? BeiGene was intentionally built differently to bring innovative medicines faster, more equitably, and affordably to patients around the world. Having so many in-house oncology researchers dedicated to that task was probably the biggest driver of advancing such an impressive pipeline. The model that we have built allows us to bring these molecules into clinical development and deliver proof-of-concept results with exceptional efficiency. Our in-house clinical development capabilities are also a key enabler of the cost and speed advantages that we are capitalizing on while also enhancing the quality of clinical data generation.”

Dr Terwey is optimistic at the prospects for BeiGene’s pipeline beyond zanubrutinib, already a leading hematology therapy, and tislelizumab, the foundation of the company’s solid tumor pipeline.

‘Technology across different platforms’

The rich and varied pipeline includes investigational medicines in existing modalities, such as monoclonal antibodies and small molecules, aimed at improving efficacy and reducing toxicity. BeiGene is also pioneering other modalities like enhanced antibody-drug conjugates, bi-specific and tri-specific antibodies, and targeted protein degraders. Regardless of mechanism, patient needs, potential clinical impact, and improving on the limitations of existing treatments are guiding principles in portfolio strategy.

“We focus on the cancer types with the highest clinical need, where breakthroughs can really make a big difference to society. These include lung cancer, breast cancer, and gastrointestinal cancers as well as blood cancers. Our pipeline is not focused on a specific modality, but rather we have technologies across different platforms to allow us to address underlying causes of disease with the most promising interventions and combinations.”

A targeted BTK degrader, a CDK4 inhibitor, and several investigational immuno-oncology assets, being studied in combination with tislelizumab, are among the leading molecules in the pipeline.

“There is, of course, more to come,” Dr Terwey said.

“It's good to see that if an organization has the courage to take some risk and is willing to build a company differently, with a clear purpose in mind in terms of broad access, how far you can get in such a short period of time in making an impact on society and patients.

“There’s a great future for BeiGene. It’s truly exciting to be part of this organization that is using the latest science and translating it into meaningful medicines that are available everywhere to every patient who needs them.”

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology