Dr Alise Reicin
SVP, Head of Global Clinical Development,
Dr Alise Reicin
Getting a better patient response is clearly one of the major challenges the IO field is faced with right now. What strategies are being implemented by Merck KGaA, Darmstadt, Germany in order to increase response rates?
We believe that rational combination is key to the future of new and more efficacious treatment options. We are currently combining our targeted therapies with chemotherapy/radiotherapy, other targeted therapies and/or immunotherapies from our own, our partners’ and other external portfolios. Our wide pipeline in healthcare, enables us to explore novel synergies and combinations with cancer therapies and immunotherapies, treating the patient as a holistic system in which multiple systemic factors all play a role in cancer–immune system interactions.
Merck KGaA, Darmstadt, Germany is taking a long-term view of the market, with the knowledge that the current generation of approved immunotherapies will need to be augmented with new platform agents and technologies to drive improved patient outcomes. To be clear, we aren’t seeking incremental benefit, but rather looking for combinations that will substantially improve on what current checkpoint inhibitors are able to achieve.
In addition to our current internally-driven efforts, Merck KGaA, Darmstadt, Germany has a strong potential for future investigation of new combinations with our partnerships and collaborations. The licensing agreement with Vertex is one illustration of this – we now have compounds targeting three different mechanisms in the DDR space in the clinic: DNA-PK, ATR, and ATM. Given emerging data demonstrating the correlation between response and tumor mutational load and tumor mutations in DDR pathways, IO/DDR combinations is an area of great interest for us.Another example is our investment in the idea of combining two mechanisms in one molecule to fight cancer. Our strategic collaboration with F-star, announced in June, enables us to develop and commercialize a number of bispecific immuno-oncology antibodies including FS118, which is designed to block both LAG-3 and PD-L1. This is of course in addition to M7824, our investigational bifunctional immunotherapy targeting PD-L1 and TGF-β, which is currently in Phase I and is showing encouraging early clinical activity.
From these strategies, which ones are proving to be successful for Merck KGaA, Darmstadt, Germany and why?
We are incredibly proud of our achievements in bringing avelumab (BAVENCIO®) to market in 2017 – in the US, avelumab has received FDA accelerated approvals in metastatic Merkel cell carcinoma (MCC) and previously treated locally advanced or metastatic urothelial cancer.
The Merck-Pfizer Alliance’s international clinical development program for avelumab, known as JAVELIN, now involves at least 30 clinical programs, including nine Phase III trials, and more than 7,000 patients across more than 15 tumor types. Exploring avelumab in combination with other therapeutics is a critical component of our development strategy for this asset. For example, one of these ongoing Phase III studies - JAVELIN Renal 101 is evaluating the combination of avelumab plus axitinib compared with sunitinib malate in patients with unresectable, locally advanced or metastatic renal cell carcinoma (RCC) with clear cell component – was informed by exciting, initial data from the JAVELIN Renal 100 Phase Ib study. This early study demonstrated a 54.5% tumor response rate from the avelumab and axitinib combination in first-line RCC.
We continue to use the knowledge and experience gained from our BAVENCIO journey to support the delivery of a transformative pipeline that continues to make a real difference for patients, with a strong focus on helping to create, improve and prolong lives.
In parallel to our late stage pipeline, our early pipeline now includes a number of highly innovative programs. With three additional IO molecules in Phase I, we are seeing promising initial data and are excited about the future of our pipeline.
How important are biomarkers and companion diagnostics to your overall immuno-oncology portfolio?
Precision medicine has long been a priority for Merck KGaA, Darmstadt, Germany. Every one of our research programs is accompanied by a biomarker approach, with the goal to try to identify the patients who are more likely to benefit from a specific treatment in order to achieve the best possible medical outcomes. We have leveraged this expertise in our oncology and immuno-oncology development programs so that we can design more specific treatments and tests to help identify those patients who will benefit most from our treatments. Our collaborations with Sysmex Inostics, Biocartis and AmoyDx led to the development of the world’s first liquid biopsy RAS biomarker tests in 2016.
Merck also works closely with top academic institutes, and has strategic alliances with Illumina and Dako as part of our biomarker discovery program running in parallel with our immunotherapy clinical trials.
Finally, you will be speaking at Phacilitate’s IO Frontiers this January. What are you looking forward to at this event and what do you hope to get out of it?
IO Frontiers will be a great opportunity to interact with and learn from top IO researchers and industry colleagues. I am particularly looking forward to being a part of the keynote panel on championing the future success of oncology portfolios – an opportunity to discuss and debate with leaders in the IO community on our shared goal of improving response rates for patients and ultimately fighting and eliminating cancer.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany, generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the „Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.