Eli Lilly’s Alimta (pemetrexed) has not been recommended in new draft guidance as a maintenance treatment option for non-small-cell lung cancer (NSCLC).

NICE recognised the effectiveness of the treatment but said the potential gain for patients is less than the NHS is being asked to pay for the drug.

A disappointed Sir Andrew Dillon said the Institute can only recommend treatments “which are both clinically and cost effective” for the NHS.

The Institute calculates that the average cost of the treatment is approximately £11,640.

Lung cancer is one of the most common cancers in the UK. NSCLC is the most common type of lung cancer and accounts for around 80% of all cases.

Alimta was being considered as a maintenance treatment option following induction therapy with the drug and cisplatin. It is already recommended as a first line treatment option for NSCLC and as a maintenance treatment option following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel.

“Alimta is already recommended as maintenance treatment following a different first line treatment,” said Sir Andrew Dillon. “However, in this case, as maintenance treatment following pemetrexed and cisplatin, although effective, the potential gain for patients is less but the cost to the NHS remains the same.

“It is disappointing not to be able to recommend pemetrexed in our preliminary guidance.”

Roche’s Tarceva (erlotinib) has been recommended in final guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

NICE’s independent Appraisal Committee concluded the treatment was a clinical and cost effective use of NHS resources, when supplied under an agreed Patient Access Scheme.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the Institute was “pleased to be able to recommend another treatment option for this stage of the disease.”

As part of the appraisal, the Committee discussed the results from the updated analysis comparing Tarceva with Iressa. On balance, the Committee concluded, the sums of money either spent or saved are small given the uncertainties associated with the data.

Therefore, when supplied under the Patient Access Scheme, Tarceva is recommended as an option with patients who have locally advanced or metastatic EGFR-TK mutation-positive NSCLC.

Elderly patients with inoperable non-small-cell lung cancer (NSCLC) have been shown to benefit from a combination of chemotherapy and radiotherapy.

In a Japanese trial, patients aged over 70 who received daily carboplatin with radiotherapy lived significantly longer than those given radiotherapy alone.

The trial, published in The Lancet, is the first to support the use of concurrent chemoradiotherapy in elderly and severely ill patients.

The study divided 200 participants with inoperable NSCLC randomly into two groups, receiving radiotherapy or chemoradiotherapy.

The overall survival for the chemoradiotherapy arm was 22.4 months, significantly longer than for the radiotherapy arm (16.9 months).

Most of the patients given chemoradiotherapy suffered some toxic effects, but the researchers judged the treatment to be “feasible and tolerable” and concluded that it “should be considered for this population”.

According to Shinji Atagi of Kinki-chuo Chest Medical Center, Osaka, Japan, elderly people were “under-represented” in previous trials of combined therapy. “This trial is the first to show that combined therapy can safely improve the outcome of stage III NSCLC in elderly patients,” he said.

However, Juan Wisnivesky of Mount Sinai School of Medicine, New York and Gary Strauss of Tufts Medical Center, Boston, warned: “Additional validation of the present findings is needed before concurrent chemoradiation can be considered standard of care in elderly patients.”

NICE has requested further data on Tarceva (erlotinib) from Roche for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC) in new draft guidance.

Roche failed to provide evidence on Tarceva’s clinical and cost effectiveness when compared to Iressa (gefitinib), NICE’s Appraisal Committee said.

Sir Andrew Dillon, NICE Chief Executive, said the data provided by Roche was not sufficient to compare Tarceva with a recommended option but hoped further information would be supplied.

The Committee has now asked Roche for an updated cost effectiveness analysis of Tarceva compared with Iressa with different progression-free survival and utility assumptions. Further sensitivity analyses on the cost of Tarceva changes depending on how many patients are able to continue taking the drug and Iressa after 60 days of treatment – the point at which the NHS currently has to start paying for Iressa under its agreed Patient Access Scheme – are also required.

“When it was asked to consider Tarceva, our independent advisory committee concluded that it did not have enough information to be able to make the decision to recommend or not recommend it for routine use in the NHS as an alternative to gefitinib,” said Sir Andrew. “It has therefore asked the manufacturer provide further analyses. We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic.”

The SMC recently approved the use of Tarceva as a first-line treatment for NSCLC. Lung cancer, after breast cancer, is the second most common cancer in England and Wales, with an estimated 40,800 newly diagnosed cases each year.

The EC has approved Eli Lilly’s Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC).

Alimta is the first chemotherapy to be approved in Europe for continuation maintenance therapy, for NSCLC patients who have shown a positive response or disease stabilisation following treatment with first-line Alimta plus cisplatin.

Allen Melemed, Senior Medical Director at Lilly Oncology, said: “Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient.”

The European approval was based on results from PARAMOUNT, a randomised double-blind Phase III study of 939 patients with advanced nonsquamous NSCLC.

The study showed that Alimta continuation maintenance therapy improved progression-free survival, as well as overall survival, after Alimta-cisplatin first-line therapy.

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

The drug is also approved for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma in the EU and US.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths every year. Approximately 85-90% of all lung cancers are NSCLC.

Alimta was recommended by CHMP as continuation maintenance therapy for patients with advanced nonsquamous NSCLC in September 2011 and by NICE for use by the NHS in September 2009.

Life Technologies is to join GlaxoSmithKline (GSK) Biologicals in developing a diagnostic to be used with a GSK cancer immunotherapy.

Life will develop a multi-gene qPCR-based molecular in vitro diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the treatment.

Kim Caple, Head of Molecular Diagnostics at Life Technologies, said: “Life Technologies' platform technologies, such as qPCR, are allowing biological knowledge to be applied in multiple markets, including companion diagnostics.”

MAGE-A3 is currently being evaluated in two clinical trials, MAGRIT and DERMA, evaluating safety for patients with non-small cell lung cancer whose melanoma has invaded lymph nodes.

Under the terms of the agreement, Life Technologies and GSK will develop and commercialise the qPCR-based test to detect MAGE-A3 positive patients most likely to benefit from MAGE-A3 ASCI. 

Based in California, Life Technologies is a global biotechnology company that manufactures both molecular diagnostic and research use only products.

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.

Eli Lilly has received a positive opinion from the CHMP for Alimta as continuation maintenance therapy of advanced nonsquamous non-small cell lung cancer (NSCLC).

The recommendation is for the pemetrexed injection to be used as part of maintenance therapy, a relatively new concept in lung cancer treatment to commence immediately after patients have completed first-line treatment, in an effort to sustain disease control.

Dr Allen Melemed, Senior Medical Director of Alimta at Lilly Oncology, said: “Lung cancer is one of the most difficult cancers to treat and new therapy options are much needed.”

The CHMP’s recommendation will be reviewed by the European Commission, which will decide whether to approve the treatment for indication in Europe.

Dr Melemed commented: “If approved, Alimta would be the first tailored treatment option based on efficacy that can potentially extend lives beginning in first-line treatment and continuing through maintenance in advanced nonsquamous non-small cell lung cancer.”

No chemotherapy is currently approved as ‘continuation maintenance’ treatment. Currently approved lung cancer maintenance therapies use different medicines in the first-line and maintenance phases of treatment.

The CHMP's opinion was based on clinical research results from Paramount, a randomised, double-blind Phase III study involving patients with advanced nonsquamous NSCLC. Participants received initial therapy with four cycles of Alimta plus cisplatin. Patients whose disease did not progress continued to the maintenance phase, where survival was assessed in patients who received Alimta plus best supportive care (BSC), compared with those who received a placebo plus BSC.

Alimta is already approved in the first-line, maintenance and second-line settings in the EU and US for the indication. The treatment was originally recommended by NICE in September 2009 to treat the cancer on the NHS in the UK, but reversed its decision in December 2009, citing data uncertainties. NICE came to a final recommendation in June 2010.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths each year. NSCLC contributes to 85-90% of all lung cancers.

Roche’s Tarceva (erlotinib) has been granted a European licence as a first-line monotherapy for patients with an advanced form of non-small cell lung cancer (NSCLC) with a certain mutation.

The licence is based on Phase III trials which showed Tarceva nearly doubled the time patients lived without their disease progressing compared with chemotherapy.

Dr Liz Toy, Royal Devon and Exeter Foundation NHS Trust, says the new indication is “exciting news” for patients who may have an “enhanced response” using the treatment.

Tarceva is already approved for use in the UK for patients with advanced or metastatic NSCLC, irrespective of a patient’s epidermal growth factor receptor (EGFR) status.

Data from the two Phase III studies, EURTAC and OPTIMAL, investigated patients with an EGFR mutation and demonstrated that Tarceva significantly increased the time patients live without the cancer progressing.

“The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment,” said Hal Barron, Chief Medical Officer and Head, Global Product Development at Roche.

More than 39,000 new cases of lung cancer are diagnosed in Britain each year.

Roche’s Tarceva (erlotinib) has received approval from the European Commission for use in patients with a type of non-small-cell lung cancer (NSCLC).

The European approval will enable its use as a first-line monotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations following impressive Phase III data.

Hal Barron, Chief Medical Officer and Head, Global Product Development, says the approval is “good news for patients”.

Tarceva is already approved in Europe for use in advanced or metastatic NSCLC, irrespective of a patient’s EGFR status, both as maintenance therapy after initial chemotherapy, and in patients whose disease has progressed following at least one course of chemotherapy.

Data from the European Randomised Trial of Tarceva vs. Chemotherapy (EURTAC) demonstrated that the treatment is superior to chemotherapy in EGFR activating mutation positive NSCLC.

The trial found that Tarceva nearly doubled median progression free survival and more than tripled the response rate compared to chemotherapy.

“The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment,” said Hal Barron.