Merck and Pfizer announced that the European Commission (EC) has approved Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The approval was based on positive interim results from the Phase III Javelin Renal 101 study, which demonstrated that Bavencio in combination with axitinib significantly lowered risk of disease progression or death by 31% and nearly doubled objective response rate compared with sunitinib in patients with advanced RCC regardless of PD-L1 status. The study included patients across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups. Improvement in progression-free survival (PFS) was observed across pre-specified subgroups in patients receiving the treatment combination.
“There is a high incidence of kidney cancer in Europe, and for the most common type, renal cell carcinoma, we continue to need additional treatment options, particularly for patients with advanced disease, where outcomes are poorest,” said Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor at the Institute of Cancer Research (ICR). “We’ve seen a demonstrated efficacy benefit and safety and tolerability profile for avelumab in combination with axitinib across all prognostic risk groups in patients with advanced renal cell carcinoma, so today’s approval in Europe brings an important option that can help healthcare professionals optimize treatment strategies across risk stratification.”
In 2018, an estimated 136,500 new cases of kidney cancer were diagnosed in Europe, and approximately 54,700 people died from the disease.2 Many patients living with advanced RCC do not go on to receive additional treatment after first-line therapy, for reasons that may include poor performance status or adverse events from their initial treatment. The five-year survival rate for patients with advanced RCC is approximately 12%.
“This first European approval of an anti-PD-L1 as part of a combination treatment for advanced renal cell carcinoma builds on our commitment to bringing innovative treatment options to patients with hard-to-treat cancers through our extensive Javelin clinical trial program,” said Rehan Verjee, Global Head of Innovative Medicine Franchises for the Biopharma business of Merck. “RCC is the most common form of kidney cancer, accounting for 90% of diagnoses. We are now working to make Bavencio in combination with axitinib available for patients with advanced renal cell carcinoma as quickly as possible.”
“The European Commission approval of Bavencio in combination with axitinib has the potential to bring even more patients with advanced renal cell carcinoma a new first-line treatment, and it allows us to continue to deliver on our more than decade-long passion to do more for patients with kidney cancer,” said Andy Schmeltz, Global President, Pfizer Oncology. “We thank all of the researchers, doctors, advocates, patients and their families who helped get us here today, and we will continue in our fight against this advanced cancer.”
The EC’s decision follows the U.S. Food and Drug Administration (FDA) approval of Bavencio in combination with axitinib for the first-line treatment of patients with advanced RCC in May 2019. A supplemental application for Bavencio in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.
Additionally, with this approval, the posology section of the Summary of Product Characteristics for Bavencio has been updated. The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks. Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity. The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Two additional production halls
Expansion of capacities for the production of consumables
The Eppendorf Group is expanding its production capacity at the Oldenburg in Holstein site in Germany by building two additional production halls. As a result, Eppendorf Polymere GmbH, a wholly owned subsidiary of Eppendorf AG, will increase its total capacity by around 30 percent from 2021. A milestone for this targeted expansion was reached May 14, 2020 with the topping-out ceremony for the second hall currently under construction. The first hall has already been completed and will start production operations this month.
In Oldenburg, Eppendorf produces laboratory consumables made of high-quality plastic such as pipette tips and tubes, microtiter plates and single-use bioreactor vessels. Currently, these products are in particularly high demand from diagnostic laboratories and vaccine manufacturers around the world who are researching vaccines against the corona virus or carrying out Sars Cov-2 tests.
“We are registering a steady increase in demand for consumables from Eppendorf. The current global battle against the corona virus is just reinforcing this trend,” says Dr. Wilhelm Plüster, Chief Technology Officer at Eppendorf AG. “With the construction of the two new production halls we are responding to this trend, which has been continuing for years. In addition, sustainability was taken into account in the construction of the buildings.” continues Plüster. The two production halls will be heated and cooled by an existing combined heat and power plant. This will considerably reduce energy consumption.
Merck, a science and technology company, is donating a total of two million FFP2 masks in Germany, France and the United States, among others. The company is covering the costs of purchasing and transporting the protective equipment. The donation is mainly intended to support healthcare workers; the relevant authorities and organizations will handle the distribution of the masks.
“During these unprecedented times, we are grateful for the dedication and great work of all those on the Covid-19 front lines. To help protect more than 30,000 healthcare professionals, we are donating up to a month’s supply of the much needed FFP2 masks. At Merck, we are focused on advancing human progress and continue to provide our resources and full dedication to overcome the Covid-19 pandemic.”
Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck
Moreover, Merck is supporting the global fight against Covid-19 through a wide range of actions. For example, the company is cooperating with other pharmaceutical and life science companies as well as the Bill & Melinda Gates Foundation to develop, manufacture and provide vaccines, diagnostics and treatment options for Covid-19. Merck is supporting the Jenner Institute in reaching an initial milestone for the industrial production of a potential Covid-19 vaccine. In addition, Merck has set up its own production capacities for disinfectant at its sites in Darmstadt and Wiesbaden, Germany, as well as Rio de Janeiro, Brazil and Norwood, US, amongst others.
In 2019, the company awarded the Future Insight Prize, a research grant worth up to € 1 million, for superb scientific achievements in the field of pandemic preparedness to Pardis Sabeti from Harvard University and the Broad Institute as well as to James Crowe from Vanderbilt University Medical Center. Like many scientists worldwide, they are currently working hard to identify diagnostics and therapeutic options for Covid-19 infections.
Measurement, Instrumentation, Control & Automation Pharmaceuticals Plant Construction, Engineering & Components
Siemens and Atos
Digital Twin solution within the global pharmaceutical industry
Atos and Siemens are working together with the pharmaceutical industry to improve production with an innovative solution based on a digital replica of the pharma production process. Currently being tested in the pharmaceutical industry, this innovative “Process Digital Twin” for pharma manufacturing – powered by IoT, AI and Advanced Analytics – is designed to provide improved efficiency and flexibility in the manufacturing of pharmaceutical products.
Based on the pilot study, this potentially disruptive solution opens up new opportunities, such as a sustainable process development – reducing overall experimentation time and waste, ensuring constant quality and moving to new “quality by design” models to get the product right the first time. The solution also offers optimized measures for process quality and reliability.
The production and release of pharmaceutical products are complex and lengthy processes. To meet these challenges, one of Atos and Siemens’ global pharmaceutical partners has decided to test a new innovative solution, built and developed through a joint investment and business collaboration from the Atos-Siemens strategic global alliance. The “Process Digital Twin” is a complete virtual replica of a specific step in the manufacturing process, connected with IoT sensors installed on the actual plant.
It generates volumes of complex data and gives an instant view of all details of the operations. By pairing virtual and physical representations of the process, and using predictive models and real-time analytics, Atos and Siemens are helping the pharmaceutical industry to reinvent key elements of the manufacturing environment.
“We are delighted to bring digital technologies to the heart of the global pharmaceutical industry, helping it meet the multiple health challenges of today and tomorrow.” says Paul Albada Jelgersma, SVP, Global Head of Codex services for IoT & Siemens MindSphere at Atos. “With the Process Digital Twin developed by Atos and Siemens, a solid digital footprint of pharmaceutical products is created throughout the process development cycle, starting from the design phase, all the way to production.”
“Digitalization at every point along the value chain will likely help the pharma industry get pharmaceuticals from the lab to the patient more swiftly.” says Rebecca Vangenechten, Head of business Pharmaceutical Industry at Siemens. “This was a challenging journey where the partners created the basis for future process development & manufacturing, based on science, technology and innovation”.
Atos provides its expertise in IT infrastructure, consulting, integration and data science, notably from its Codex expertise in AI and IoT solutions and services – while Siemens provides its Digital Enterprise expertise in OT systems for Pharma, notably with Simatic Sipat for real-time quality monitoring and StarCCM+ & HEEDS for process modeling & simulation.
The nature of Atos and Siemens’ pre-integrated Digital Twin solution allows it to be deployed to production processes of any scale or complexity. By adjusting the technological building blocks Atos and Siemens can replicate Digital Twin use case to every new client – within pharmaceutical, chemical, process manufacturing industries and other markets – more efficiently.