Combining new drug palbociclib with a hormone therapy called fulvestrant could extend survival for some women with metastatic breast cancer, a major clinical trial suggests.
The trial tested the benefit of adding palbociclib to fulvestrant in 521 women with advanced, hormone positive, HER2 negative breast cancer.
While women taking palbociclib with fulvestrant in the trial (PALOMA-3) lived nearly seven months longer than those on fulvestrant alone, these results were not statistically significant. However, a specific group of patients – those whose breast cancer initially responded to anti-hormone treatments – did see a significant extension of life, of 10 months.
Palbociclib is part of a new class of drugs that work by inhibiting two crucial cell division proteins called CDK4 and CDK6 – known as CDK4/6 inhibitors. The drug is already available on the NHS as a first-line treatment for post-menopausal patients with hormone receptor (HR) positive, HER2 negative locally advanced or metastatic breast cancer – having been approved in this indication by the National Institute for Health and Care Excellence (NICE) in November 2017.
Recent clinical trials have found that giving palbociclib in combination with fulvestrant as a second-line treatment can delay the progression of the disease (known as progression-free survival), which is known to be highly valued by patients – but the evidence remains uncertain as to whether this translates into overall life-extension.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
These are exciting results for a landmark therapy that we know can offer women with incurable breast cancer precious extra time before their disease gets worse. But, with this patient group desperately in need of new hope, it’s important to highlight that further research is needed to confirm whether this treatment may also extend their lives.
Palbociclib offers a life-changing and long-awaited step forward in treatment for many patients with incurable breast cancer, and we were delighted to see it made available on the NHS as a first-line therapy earlier this year. We are extremely excited to now be seeing that it could prove a new option for even more women, who have already progressed on hormone therapy, if given in combination with fulvestrant.
However, we are very concerned that this major advance will not be able to reach NHS breast cancer patients, as the appraisal methodology has not been updated to cope with modern combination therapies. With the cost of all parts in the combination counting towards the threshold, it remains very difficult for add-on therapies like this to be considered as cost-effective by NICE.
We simply cannot let research progress like this pass NHS patients by, and we urge for reform to NICE’s appraisal methodology to ensure new and effective combination therapies can be made available quickly at a price the NHS can afford.