Merck KGaA and Pfizer Show that Phase 3 Combination Therapy Delays Progression of Kidney Cancer

Edward Kim  |

~ Bavencio (avelumab) + Inlyta (axitinib) show statistically significant improvement in progression-free survival vs Sutent (sunitinib) ~

There are over half a million people in the US living with kidney and renal pelvis cancer, according to 2015 data from the National Cancer Institute. About 1.7% of the population will be diagnosed at some point, according to the American Cancer Society, making kidney and renal pelvis cancer among the 10 most common cancers in both men and women. Over 63,000 new cases of kidney cancer will occur in 2018, and about 15,000 people will die from the disease. Renal cell carcinoma (RCC) is the most common type of kidney cancer, and one that is stubbornly resistant to chemotherapy and radiation therapy. About 20% to 30% of RCC patients aren't diagnosed until the metastatic stage, and the five-year survival rate for patients with metastatic RCC is only 12%.

Merck KGaA  (MKKGY) and Pfizer  (PFE) announced positive top-line results today from their pivotal 886-patient Phase III study, called JAVELIN Renal 101, evaluating the combination of Bavencio (avelumab) and Inlyta (axitinib) as a first-line therapy for patients with advanced renal cell carcinoma. As part of a planned interim analysis, an independent Data Monitoring Committee confirmed a "statistically significant improvement" in progression-free survival compared to patients treated with Sutent (sunitinib), a drug for which Pfizer first received approval in 2006 for gastrointestinal stromal tumors and advanced renal cell carcinoma (RCC). The combination of the two drugs was granted Breakthrough Therapy Designation by the FDA in December 2017. The companies didn't disclose specific data with this announcement, but they did say that they intend to pursue an FDA submission based on these interim results. A detailed analysis will also be submitted for presentation at an upcoming medical congress.

Source: Osmosis

Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody that was developed collaboratively by Merck KGaA and Pfizer. By blocking the interaction of PD-L1 with PD-1 receptors, Bavencio helps the body's immune system fight cancer cells. The drug was approved by the FDA in 2017 for the treatment of metastatic merkel cell carcinoma and urothelial carcinoma. These indications were approved under The FDA's accelerated approval protocol based on tumor response rate and duration of response.

Inlyta is an oral tyrosine kinase inhibitor (TKI). Tyrosine kinases are a family of enzymes involved in various cell functions, including cell signaling, growth and division, and include vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which can influence tumor growth, vascular angiogenesis and the progression of cancer. Pfizer received FDA approval in 2012 for Inlyta in the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

This is the first positive Phase III trial combining immunotherapy with a tyrosine kinase inhibitor in any tumor type.

JAVELIN Renal 101 is the first positive Phase III study combining an immune checkpoint blocker with a TKI, supporting the potential of Bavencio and Inlyta as a new cancer treatment approach for patients with advanced RCC. These positive results reinforce Pfizer’s long-standing heritage in advancing standards of care for people with RCC, and we look forward to discussing these data in greater detail with health authorities.”

- Chris Boshoff, MD, PhD, SVP and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development.

We are encouraged by these data which illustrate the impact of Bavencio in combination with Inlyta as a potential first-line treatment for people with advanced RCC, a serious and life-threatening cancer. They also support our firm belief in the promise of combining Bavencio with currently approved therapies and novel agents, a strong focus of the overall JAVELIN clinical development program.

- Luciano Rossetti, MD, EVP, Global Head of Research & Development at the Biopharma business of Merck KGaA.

The JAVELIN clinical development program involves at least 30 clinical programs, eight Phase III trials and more than 8,600 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, Merkel cell carcinoma, non-small cell lung cancer, ovarian and urothelial carcinoma.

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DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to:


Symbol Name Price Change % Volume
PFE Pfizer Inc. 40.51 -0.10 -0.25 21,901,267 Trade
MKKGY Merck KGaA (Germany) ADR (Sponsored) 25.67 0.03 0.10 6,726



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