Regorafenib now available on NHS Wales for treatment of advanced GIST

The All Wales Medicines Strategy Group (AWMSG) has announced that Bayer’s Stivarga® (regorafenib) has been recommended for use on NHS Wales for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST), who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

GIST is the most common form of sarcoma – a type of cancer that develops from soft-tissue connective cells – located in the gastrointestinal tract. GIST is a rare cancer, approximately 900 new diagnoses are made in the UK each year and is most common in people between 50-70 years old. Patients are usually diagnosed in the later stages of the disease with metastasis occurring in 40-90% of patients within five years. Patients can experience pain or discomfort in the abdomen, blood in stools or vomit, a feeling of fullness and can even cause them to become anaemic.

“The AWMSG decision to recommend regorafenib as a third-line treatment for advanced GIST within NHS Wales, is positive news for patients and their physicians. GIST is a rare but aggressive cancer, which causes significant pain and discomfort at advanced stages. Regorafenib offers a new treatment option for patients with GIST whose cancers have progressed after treatment with current standards of care,” said Richard Condon, Business Unit Head Specialty Medicine, Bayer UK & Ireland.

Regorafenib significantly improved PFS

The approval of regorafenib in GIST is based on results of the pivotal Phase III GRID study which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib, reducing the risk of progression or death by 73%. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm. The increase in PFS was consistent and independent of patient age, sex, and geographic region, prior lines of treatment or Eastern Cooperative Oncology Group (ECOG) performance status.

Regorafenib was approved for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib, in July 2014 in the European Union.