NICE backs stomach cancer, PAH drugs for NHS use

UK reimbursement authority NICE has recommended that the NHS in England can use AstraZeneca's Imfinzi as the first immunotherapy for an aggressive form of stomach cancer, and MSD's Winrevair for pulmonary arterial hypertension (PAH).

The Imfinzi (durvalumab) decision comes less than three weeks after the PD-L1 inhibitor was approved by the UK's drug regulator, the MHRA, as part of a pre- and post-surgery regimen for gastric and gastro-oesophageal junction (GEJ) cancer that hasn't spread to other parts of the body.

The final draft guidance (PDF) covers neoadjuvant use of Imfinzi in combination with chemotherapy before surgery, followed by the use of AZ's drug as an adjuvant monotherapy after the procedure, and has been developed using a streamlined NICE appraisal process that allows guidance to be delivered without the need for a committee meeting.

NICE said that more than 1,500 people in England will be eligible for treatment with Imfinzi in this perioperative regimen, which has been shown in clinical trials to delay recurrence of the cancer and extend survival.

The appraisal drew on the MATTERHORN trial, which involved patients with stage II, III, and IVA gastric and GEJ cancer and showed that Imfinzi achieved a 29% improvement in event-free survival (EFS) and extended overall survival (OS) by 22% compared to giving chemotherapy alone in the neoadjuvant setting.

Recurrence of this type of cancer tends to be high, and Imfinzi raised the proportion of patients who lived for at least three years after surgery to 68.6% compared to 61.9% in the control group.

AZ said in its fourth-quarter 2025 results that the MATTERHORN data was also helping to drive "encouraging uptake" of Imfinzi, which grew 28% to top $6 billion in sales for the first time in 2025.

"This is the first major advance in curative-intent treatment for stomach cancer in nearly a decade," said Sheena Dewan, executive director at Stomach Cancer UK.

"Adding immunotherapy to perioperative chemotherapy offers a real opportunity for lower recurrence and longer survival," she added. "For too long, patients have been enduring the dual burden of life-altering surgery and high rates of recurrence."

Winrevair backed as add-on PAH therapy

Meanwhile, Winrevair (sotatercept) – a first-in-class ActRIIA-Fc fusion protein billed as the first disease-modifying therapy for PAH – can now be used in combination with current drugs to increase exercise capacity in patients with WHO class 2 or 3 (low, intermediate–low or intermediate–high risk) PAH.

PAH is a rare, severe and life-threatening form of pulmonary hypertension, characterised by high blood pressure in the pulmonary arteries that supply the lungs, and causes the walls of these vessels to become thick and stiff, resulting in damage to the heart muscle and symptoms such as shortness of breath and fatigue.

Current treatment options have resulted in a median survival of five to seven years from diagnosis, but no substantial improvements in survival have been realised over the past decade, according to MSD.

Dr Iain Armstrong, chair of the Pulmonary Hypertension Association (PHA) UK, said the new guidance (PDF) is a "significant moment" for the patient community, but added: "A positive NICE recommendation is not the end of the road. It is the beginning of the next stage. Access on paper must become access in practice, and that requires sustained, active work."