Patients diagnosed with cervical cancer in the United Kingdom are set to receive the first immunotherapy drug for an advanced form of the disease following the publication of the final draft guidance by National Institute for Health and Care Excellence (NICE) recommending the use of pembrolizumab (Keytruda®; Merck & Co/Merck Sharp & Dohme) in combination with chemotherapy for use in patients with persistent, recurrent, or metastatic cervical cancer whose tumors are programmed death-ligand 1 (PD-L1)-positive and do not respond to other treatments.

The recommendation is the first new treatment for incurable cervical cancer in 14 years.[1]

Cost Effective
Clinical trial evidence shows that people on the treatment have a longer time without their disease getting worse than people having standard care. It also suggests they may live longer overall. But it is unclear how much longer it takes for their cancer to get worse, or how much longer they live for, because the trial hasn’t finished yet.

Because of this uncertainty it is difficult for the NICE committee to establish if the medicine is cost effective. This uncertainty may be reduced by collecting and analyzing data from the ongoing clinical trial.

The CDF pays for cancer treatments while data is collected on their clinical effectiveness. This means people can have earlier access to treatments while further clinical evidence is generated. This data is then used when NICE re-evaluates a treatment to decide whether it is clinically and cost effective to be used routinely on the NHS.

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“We have recommended 53 cancer treatments for use in the CDF since 2016, benefitting around 55,000 people. Most treatments funded by the CDF are subsequently recommended by NICE for routine NHS use,” noted Helen Knight, director of medicines evaluation at NICE, said:

“People with advanced cervical cancer have limited treatment options beyond standard care and an effective treatment would be welcomed,” Knight added.

“Pembrolizumab shows promise as the first effective immunotherapy. However, to ensure the best use of limited public funding, we need additional evidence to fully analyze its clinical and cost effectiveness before it can be considered for routine NHS use, Knight said.

“Recommending pembrolizumab to the CDF means people have faster access to care while this further evidence is gathered,” she concluded.

Helen Olivia Bicknell Whately, Minister of State for Social Care in the United Kingdom.

A win for women
“Today is a win for women, offering the hope of more precious time with loved ones. commented Helen Olivia Bicknell Whately, Minister of State for Social Care in the United Kingdom.

“We are committed to providing world-class cancer care to patients and always working to find trailblazing, new treatments.”

“This has been made possible by the government’s £340 million Cancer Drugs Fund, which has helped thousands of patients to benefit from rapid access to promising new cancer treatments,” Whately added.

Recommendation
NICE’s draft guidance recommends pembrolizumab with chemotherapy (with or without bevacizumab; Avastin®; Roche/Genentech) as an option for treating persistent, recurrent or metastatic cervical cancer in adults whose tumors express programmed cell death ligand 1 (PDL1) with a combined positive score (CPS) of at least 1 if the pembrolizumab is stopped at 2 years of uninterrupted treatment.

Cervical cancer develops when abnormal cells in the cervix lining grow in an uncontrolled way, forming a tumor. Nearly all cervical cancers are caused by an infection from certain types of human papillomavirus (HPV). It can often be prevented by attending cervical screening, which aims to find and treat changes to cells before they turn into cancer.

Cervical cancer is defined as persistent when it does not respond to treatment. It is defined as recurrent when it has returned after treatment, and metastatic when it has spread beyond the cervix to other places in the body.

Standard care for persistent, recurrent or metastatic cervical cancer includes chemotherapy with or without bevacizumab.

Why important
“According to Cancer Research UK, approximately 2,600 women are diagnosed with cervical cancer each year in England, with a high proportion of these women diagnosed between the ages of 30 and 34. Advanced cervical cancer is an aggressive and incurable disease, therefore increasing the number of therapeutic options for this patient population remains a key unmet need,” noted James Donagher, Oncology & Hematology Analyst at GlobalData.

“NICE’s recommendation is based on results from the pivotal Phase III KEYNOTE-826 trial, in which pembrolizumab and chemotherapy improved median progression-free survival (PFS) by up to 8 months compared to chemotherapy alone.[1]

“Although pembrolizumab is already offered by NHS England to treat other cancer indications, it is the first new addition to the NHS treatment portfolio for incurable cervical cancer since 2009. NHS England and the Cancer Drugs Fund (CDF) have fast-tracked this therapeutic combination to be immediately accessible to this patient population from March 30, 2023, while further evidence on the exact survival benefit is collected and analyzed.”

Clinical trails
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) – NCT03635567

Highlights of prescribing information
Pembrolizumab (Keytruda®; Merck & Co/Merck Sharp & Dohme) [SmPC/Product Characteristics]
Bevacizumab (Avastin®; Roche/Genentech)[SmPc/Product Characteristics]

Reference
[1] Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yañez E, Gümüş M, Olivera Hurtado de Mendoza M, Samouëlian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18. PMID: 34534429.

Featured image by Nicolas J Leclercq on Unsplash

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