The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending Tagrisso (osimertinib) be made available within the National Health Service (NHS) in England and Wales to treat a particularly aggressive form of lung cancer — a change in its position from May, which prompted AstraZeneca, the drug’s developer, to submit new and more clinical evidence for review.
The treatment is now recommended as a second-line option within the Cancer Drugs Fund (CDF) for adults with advanced non-small-cell lung cancer with a specific mutation, known as EGFR T790M-positive. Experts predict that about 300 patients in England and Wales will be eligible for the drug every year.
Tagrisso is a once-daily, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor that directly targets lung cancer cells, making patients less susceptible to the severe side effects seen with other chemotherapy treatments. Based on tolerability data, the clinical experts of NICE’s committee agreed that there will be fewer visits to the hospital associated with Tagrisso because it is better tolerated than other treatments, such as platinum-doublet chemotherapy.
Tagrisso was granted an “expedited conditional marketing authorization” for the European Union in February, and is the first drug to benefit from the U.K.’s new CDF arrangements, in which cancer drugs that receive a positive NICE recommendation are immediately be funded by NHS England.
NICE’s appraisal committee reviewed the clinical evidence submitted by AstraZeneca in May and concluded that while the drug had shown early promise, its clinical benefits in the long-term were uncertain and it could not be considered cost effective.
In response, AstraZeneca submitted additional clinical evidence and cost-effectiveness analyses that focused on the population of patients whose disease had been treated with first-line tyrosine kinase inhibitor therapy. The data came from a pooled analysis of the AURA extension (NCT01802632) and AURA 2 (NCT02094261) studies, whose results showed that treatment with Tagrisso led to an overall-response rate of 66 percent, meaning exceptional reductions in the size of tumors. The studies also demonstrated a prolonged progression-free survival of 4.4 months in patients receiving Tagrisso, compared with platinum doublet chemotherapy.
The NICE committee subsequently decided that Tagrisso could be included on the CDF.
Professor Carole Longson, director of the health technology evaluation center at NICE, said in a news release: “For the first time, we are able to give patients access to a promising new cancer treatment whilst more evidence is gathered on its effectiveness. This is the system working as it should.”
Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, described the decision as a ‘breakthrough.’ “This new type of targeted therapy is an exciting development in the treatment of lung cancer. For many of our patients and their families this is a breakthrough moment – a recognition that these new medicines can truly benefit people with an advanced form of the disease,” Chadwick said. “We welcome the announcement — it is good news for patients with the appropriate type of lung cancer.”
AstraZeneca announced in July that the AURA3 (NCT02151981) Phase 3 trial, assessing the efficacy and safety of Tagrisso, had met its primary endpoint, demonstrating superior progression-free survival compared to standard platinum-based doublet chemotherapy, and also demonstrated a safety profile consistent with previous AURA trials. These results will be presented at a future medical meeting.
Tagrisso was approved by the U.S. Food and Drug Administration to treat advanced non-small-cell lung cancer patients with this mutation in November 2015.