'Exciting' Lung Cancer Drug Approved for CDF

Peter Russell

March 29, 2019

Cancer experts welcomed a decision by the National Institute for Health and Care Excellence (NICE) to approve a "promising" new lung cancer treatment for England's Cancer Drugs Fund (CDF).

The announcement came as NICE also updated its guidelines on diagnosing and managing lung cancer.

New Lung Cancer Treatment for the CDF

NICE approved durvalumab (Imfinzi, AstraZeneca) for immediate inclusion in England's Cancer Drugs Fund (CDF) as an option for treating locally advanced unresectable non-small-cell lung cancer  in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation.

In draft final guidance, it said there were currently no treatment options to delay or stop the disease progressing following platinum-based chemoradiation.

NICE said that evidence from a clinical trial suggested that the PD-L1 inhibitor was more effective than standard care in delaying disease progression after concurrent platinum-based chemoradiation (chemotherapy and radiation at the same time).

It said participants on the PACIFIC trial, funded by AstraZeneca and still ongoing, went for an average of around 2 years without the disease progressing, compared with 6 months for those not treated with durvalumab.

A committee agreed that it was plausible that between 27% and 40% of people taking durvalumab could have 5 years of progression-free survival. Appraisers noted that clinical experts had defined durvalumab as "a potentially curative treatment" but the committee said clinical trial data were too immature for this to be certain.

Final data from the PACIFIC trial is not expected until September 2021.

NICE decided that although durvalumab had the potential to be cost effective for routine NHS use, there was currently insufficient evidence to recommend it.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "We are pleased to make this exciting new option available and look forward to seeing further data on the effectiveness of durvalumab.

"After relatively few developments in the past 2 decades for people with this type of lung cancer, this decision will be particularly welcome to those with the condition, their families, and the healthcare staff and experts working with them."

The cost of durvalumab is £592.00 per 120 mg/2.4 ml vial, or £2466.00 per 500 mg/10 ml vial. However, the manufacturer has agreed a confidential discount to the list price.

An estimated 165 people could be eligible to receive the immunotherapy treatment in the first year, NICE said.

Commenting on NICE's decision, Prof James Spicer, consultant in medical oncology and professor of experimental cancer medicine at Guy's and St Thomas' NHS Foundation Trust, said: "Immune therapies have already had a huge impact for many cancers, but mostly in patients where the tumour has already spread around the body. Now, patients with localised lung cancer, completing treatment with combined radiotherapy and chemotherapy, can be offered the immunotherapy drug durvalumab. The trial suggests that this treatment reduces the risk of the disease returning."

Dr Fiona McDonald, a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust, who advised the committee, commented: "This decision marks the biggest advance we've seen for a number of years in treating locally advanced non-small cell lung cancer.

"For our patients it’s fantastic news; I expect to see an immediate impact on clinical practice, and for this treatment to become the standard of care for eligible patients.

"The trial on which the decision is made showed a step-change increase in survival rates and demonstrates a clear benefit of immunotherapy, given after the current standard of care, concurrent chemoradiation."

The Roy Castle Lung Cancer Foundation welcomed NICE's decision. Lorraine Dallas, director of information and support, said: "Durvalumab offers eligible patients a treatment option which will increase their chance of living longer with lung cancer. We see access to further treatment for people with stage 3 lung cancer as a positive development.

"It adds another dimension to the use of immunotherapies in treating earlier as well as advanced stage lung cancer.

"New treatments, increased understanding of genetic changes driving lung cancer, and initiatives improving early stage diagnosis give us reason for hope. We are seeing changes in managing lung cancer that will mean better quality of life for those affected and challenge the stigma and nihilism around this disease."

Publication of final guidance by NICE is expected on 1st May 2019.

Diagnosis and Management of Lung Cancer

Separately, NICE also published a final update of its clinical guideline on the diagnosis and management of non-small cell and small cell lung cancer.

The aim of the update was to improve outcomes for patients by ensuring that the most effective tests and treatments were used, and that people had access to suitable palliative care and follow-up.

Changes made since the guideline was last updated in 2011 included clearer recommendations on:

  • Intrathoracic lymph node assessment

  • Brain imaging for people with non-small cell lung cancer

  • Radical radiotherapy (including stereotactic ablative radiotherapy) for people with non-small cell lung cancer

  • Chemoradiotherapy and surgery for people with stage IIIA-N2 non-small cell lung cancer

Thoracic radiotherapy and prophylactic cranial irradiation for people with small cell lung cancer

Diabetes Treatment

Ertugliflozin (Steglatro, Merck Sharp & Dohme) as monotherapy was recommended by NICE as an option for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control.

In final guidance, it said that patients would be eligible only if a dipeptidyl peptidase 4 (DPP-4) inhibitor would otherwise be prescribed, and a sulfonylurea or pioglitazone was not appropriate.

An appraisal committee also decided that ertugliflozin in a dual-therapy regimen in combination with metformin could be recommended as an option for treating type 2 diabetes, only if a sulfonylurea was contraindicated or not tolerated, or the patient was at significant risk of hypoglycaemia or its consequences.

NICE said that indirect comparisons showed that ertugliflozin had similar overall health benefits to canagliflozin (Invokana, Janssen-Cilag), dapagliflozin (Forxiga, Bristol-Myers Squibb and AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim). However, the cost of ertugliflozin (£29.40 per pack of 28 tablets) was lower than the costs of these other drugs.

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