21 December 2018

The drug lenalidomide significantly improves the outlook for patients with newly-diagnosed myeloma, according to the findings of a major UK trial.

The findings will add to pressure on the National Institute for Health and Care Excellence to broaden its approval for the drug to enable it to be used as a front-line treatment.

Researchers led by Professor Graham Jackson from Newcastle University conducted a seven-year randomised controlled trial of the treatment involving nearly 2,000 patients. In this part of the Myeloma XI trial, patients were randomised to receive either lenalidomide maintenance therapy or observation after their initial therapy.

Reporting in the journal Lancet Oncology, the researchers say that in the whole patient population, lenalidomide improved progression-free survival, extending remission by 19 months on average, but did not improve overall survival.

However, pre-planned subgroup analyses suggested that some patients may benefit more than others.

In patients eligible for a bone marrow transplant, who are typically younger and healthier, lenalidomide prolonged average remission time by more than two years. In patients not eligible for transplant, the improvement was more than a year. A small but statistically significant improvement in overall survival was seen in transplant-eligible patients.

Stratifying patients by cytogenetic risk also appeared to indicate patients who may see a gain in overall survival, but further studies are needed to confirm this trend.

Researcher Professor Gordon Cook, from Leeds University, said: "Our results confirm lenalidomide can significantly prolong the lives of people living with myeloma in the largest trial to date.

"This treatment is not yet available on the NHS for this group of patients and this represents an unmet need."

Professor Graham Jackson said: "This is a major breakthrough as it shows that the long-term use of lenalidomide significantly improves the time myeloma patients stay in remission after initial therapy.

"It is a huge step and, importantly, identifies that for younger patients lenalidomide improves their overall survival for this difficult-to-treat bone marrow cancer.”

Patient Sarah Williamson, aged 41, a communications executive from Darlington, said: "When I was asked if I wanted to be part of the clinical trial I didn't hesitate to say 'yes' and I was delighted that I was randomly selected to get lenalidomide as I've responded very well to the drug.

"For patients to get an extra two years remission is fantastic and it's what every person with the condition hopes for as it means they can get their life back to as normal as possible.

"I have hardly any side effects of the treatment and all my pain is gone. I feel lenalidomide should be available on the NHS.”

She added: "When I meet people who have the condition and are not on the trial I feel a sense of injustice on their behalf as taking this drug has helped me get my life back and I am enjoying it to the full."

Source: Jackson, G.H., Davies, F.E., Pawlyn, C., Cairns, D.A., Striha, A., Collett, C., Hockaday, A., Jones, J.R., Kishore, B., Garg, M., Williams, C.D., Karunanithi, K., Lindsay, J., Jenner, M.W., Cook, G., Russell, N.H., Kaiser, M.F., Drayson, M,T., Owen, R.G., Gregory, W.M., Morgan, G.J., for the UK NCRI Haemato-oncology Clinical Studies Group (2018) “Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial”, Lancet Oncology, available at doi: 10.1016/S1470-2045(18)30764-2


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