EMA Decision on Lung Cancer Med Called ‘Major Cause of Concern’

When, for the first time in decades, a trial last year showed an improvement in survival in patients with stage III inoperable non–small cell lung cancer (NSCLC), the results swiftly led to approval of the immunotherapy that had demonstrated this benefit — durvalumab (Imfinzi, AstraZeneca).

However, unlike regulatory authorities elsewhere in the world, the European Medicines Agency (EMA) decided to restrict use of this drug to patients whose tumors were positive for programmed death ligand 1 (PD-L1).

Now, this decision has been condemned by lung cancer experts as depriving patients of potentially curative treatment.

An editorial criticizing the decision was published online in the Annals of Oncology on January 8.

The authors describe the EMA’s decision as “surprising” and “a major cause for concern among the thoracic oncology community.”

“At a time when the therapeutic options are improving for lung cancer, a lethal disease for the vast majority of the patients, we worry that the present EMA decision could result in a lost therapeutic opportunity in the curative setting for a sizeable subset of patients,” they write.

Solange Peters, MD, PhD, the lead author of the editorial, is head of medical oncology and chair of thoracic malignancies in the Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Her coauthors include 21 experts in lung cancer from across Europe, as well as experts from Australia and the United States.

Improved Survival Demonstrated

The approval application for this indication was based on the results from the PACIFIC trial, presented recently at the 19th World Conference on Lung Cancer and published simultaneously in the New England Journal of Medicine. Those results show that treatment with durvalumab after chemotherapy was associated with significantly longer overall survival compared with placebo.

As reported at the time by Medscape Medical News, this study demonstrated, for the first time in decades, an improvement in overall survival for patients with locally advanced stage III unresectable NSCLC.

A secondary endpoint analysis of patient-reported outcomes also indicatedthat durvalumab was well tolerated and did not affect quality of life. Some symptoms, such as dysphagia and alopecia, even improved.

These results led to the approval by the US Food and Drug Administration (FDA) in February 2018 of durvalumab as consolidation therapy after chemoradiotherapy in unselected patients with unresectable stage III NSCLC.

Similar approval was granted by regulatory agencies in Canada, Japan, Australia, Switzerland, Malaysia, Singapore, India, and the United Arab Emirates, despite concerns over its cost-effectiveness.

The EMA, however, chose in July 2018 to limit the use of durvalumab to those patients with tumors that had high levels of expression of PD-L1.

https://www.medscape.com/viewarticle/908045