European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Adult Patients with Advanced Renal Cell Carcinoma (RCC)

01 November 2019

European Commission Approves BAVENCIO^® (avelumab) Plus Axitinib Combination for First-Line Treatment of Adult Patients with Advanced Renal Cell Carcinoma (RCC)

 

• Approval is based on the results of the Phase III study JAVELIN Renal 101, which showed that this combination lowered the risk of disease progression or death by 31% compared with sunitinib in patients with advanced RCC irrespective of PD-L1 status.

 

Feltham (Merck) & Walton Oaks (Pfizer), Monday 28 October 2019 – Merck and Pfizer today 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 a PD-L1 inhibitor in combination with axitinib (a VEGF inhibitor) significantly lowered risk of disease progression or death by 31% (HR: 0.69 [95% CI: 0.574–0.825; p<0.0001]) and nearly doubled the objective response rate (ORR; 52.5% [95% CI: 47.7-57.2] vs. 27.3% [95% CI: 23.2-31.6]) compared with sunitinib in patients with advanced RCC irrespective of PD-L1 status.¹

 

“Advanced kidney cancer has a devastating impact on patients' quality and longevity of life and there is an unmet need to improve on the current available treatment and treat this disease with newer drugs,” said Dr Balaji Venugopal, Honorary Clinical Senior Lecturer, University of Glasgow. “Avelumab, a novel immunotherapy, in combination with axitinib has demonstrated clinically significant and meaningful improvements in efficacy by extending the time without worsening of cancer and causing tumour shrinkage, along with a generally manageable safety profile compared to currently available treatment. Notably this benefit is seen in all prognostic risk groups in patients with advanced renal cell carcinoma and can help healthcare professionals optimise their patients’ treatment. Today's approval is a step in the right direction and it is exciting to be able to treat our patients first-line with this novel combination​ to improve outcomes for our patients.”

Since the early 1990s, kidney cancer incidence rates have increased by almost 87% in the UK² and it is expected to be one of the fastest growing cancers over the next decade due to a range of factors including the UK’s aging population, smoking and the rise in obesity.³ More than 12,000 people are diagnosed with renal cell carcinoma (RCC) in the UK each year and it is now the seventh most common cancer in British adults.⁴

 

Approximately 40% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.^4,5 About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy,⁶ for reasons that may include poor performance status or adverse events from their initial treatment.^6,7,8  The five-year survival rate for patients with metastatic RCC is approximately 12%.⁹

 

Nick Turkentine, CEO of Kidney Cancer UK said: “Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for over 80% of all cases of the disease. Around 4,500 kidney cancer deaths occur in the UK every year and people with advanced RCC have typically faced very poor outcomes. There is a considerable need for more treatment options, and we are pleased this new treatment for advanced RCC has been approved to be used in the UK. It’s important that it is now made available to patients who need the treatment as soon as possible.”

 

“Approval of the combination of Bavencio with axitinib for people with advanced RCC across all prognostic groups, allows patients to benefit from both an anti-PD-L1 immunotherapy combined with a VEGF inhibitor in first line,” said Belinda Byrne, Medical Director, Merck UK & Ireland “our focus now is to work with funding bodies across the UK to ensure patients have access to this much needed treatment option.”

 

“The European Commission approval of BAVENCIO in combination with axitinib has the potential to bring new first-line treatment options to patients living with advanced renal cell carcinoma,” Olivia Ashman, Oncology Medical Director, Pfizer UK. “Pfizer has been developing treatments for patients with kidney cancer for over a decade and, through the Alliance with Merck, will continue to help fight against advanced forms of this disease.”

 

The National Institute for Health and Care Excellence (NICE) technology appraisal for avelumab in combination with axitinib for untreated advanced or metastatic renal cell carcinoma is in development. The first committee meeting is scheduled for 15 January 2020, and the expected publication date for the final appraisal document is 08 April 2020.¹⁰

PD-L1 is a protein expressed on the surface of cells, which binds to PD-1 receptors on T cells of the immune system to stop them from attacking them. Some tumour cells also have PD-L1 proteins on their surface (‘PD-L1 positive’ status), preventing the immune T cells from recognising and attacking them.¹¹ BAVENCIO is an antibody which binds to PD-L1 on tumour cells and blocks it from binding to the PD-1 receptors on T cells, allowing the immune system T cells to recognise and kill the cancer cells.¹²

 

Media contacts

Merck UK
Email: Charlotte.davies@merckgroup.com 
Tel: +44 7779 568540

 

Pfizer UK
Email: tom.rhodes@pfizer.com
Tel: +44 7826 932191

 

Notes to Editors

Data from JAVELIN Renal 101 Study Supporting Approval

This approval was based on interim data from the ongoing Phase III JAVELIN Renal 101 study, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced RCC with a clear cell component. The study included patients across risk groups (International Metastatic Renal Cell Carcinoma Database Consortium [IMDC]: 21% favourable, 62% intermediate and 16% poor). The primary efficacy endpoints were progression-free survival (PFS) as assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD‑L1 expression level ³1%). If PFS was statistically significant in patients with PD-L1-positive tumours, it was then assessed in all patients irrespective of PD-L1 expression. PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD‑L1 expression, objective response, time to response (TTR), duration of response (DOR) and safety are included as secondary endpoints.

 

About the Merck-Pfizer Alliance

The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialise avelumab. The alliance is focused on developing high-priority international clinical programmes to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

 

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – Merck is everywhere. In 2018, Merck generated sales of    €14.8 billion in 66 countries.

 

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

 

Pfizer: Breakthroughs that change patients’ lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. In the UK, Pfizer has its business headquarters in Surrey and is a major supplier of medicines to the NHS. To learn more about our commitments, please visit us at www.pfizer.co.uk or follow us on Twitter (@Pfizer_UK) and Facebook (@PfizerUK).

 

Update to BAVENCIO Summary of Product Characteristics

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. 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.

 

References

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^[1] BAVENCIO® (avelumab) EU SmPC – [Last accessed October 2019]

² Cancer Research UK. Kidney Cancer Statistics- Kidney Cancer Incidence. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer#heading-Zero [Last accessed: October 2019]

³Cancer Research UK. Science Blog- Kidney cancer rates are increasing, so what’s fuelling the surge? https://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/ [Last accessed: October 2019

⁴Kidney Cancer Support Network. About kidney cancer. https://www.kcsn.org.uk/information-hub/faqs/#1458233448562-4573cb31-4829 [Last accessed: October 2019]

⁵ Klatte T, Rossi SH, Stewart GD. Prognostic factors and prognostic models for renal cell carcinoma: a literature review. World J Urol. 2018;36(12):1943-1952

⁶ Eggers H et al. Predictive factors for second-line therapy in metastatic renal cell carcinoma: a retrospective analysis. J Kidney Cancer VHL. 2017;4(1):8- 15.

⁷ Eichelberg C et al. SWITCH: A randomised, sequential, open-label study to evaluate the efficacy and safety of sorafenib-sunitinib versus sunitinib-sorafenib in the treatment of metastatic renal cell cancer. Eur Urol. 2015;68;837-847.

⁸ Motzer RJ et al. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014;32:2765-2772.

⁹ Ridge C, Pua B, Madoff D. Epidemiology and staging of renal cell carcinoma. Semin Intervent Radiol. 2014;31(1):3-8

¹⁰ National Institute for Health and Care Excellence. Avelumab with axitinib for untreated advanced or metastatic renal cell carcinoma [ID1547]- In development [GID-TA10459] https://www.nice.org.uk/guidance/indevelopment/gid-ta10459 [Accessed October 2019]

¹¹Alsaab H et al. PD-1 and PD-L1 checkpoint signalling inhibition for cancer immunotherapy: mechanism, combinations and clinical outcome. Front. Pharmacol. 2017;8:561

¹²Motzer R et al. Avelumab plus atixinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019;380:1103-15

 

UK&IE/AVEKI/0919/0026

PP-BAV-GBR-0127

Date of preparation: October 2019