AstraZeneca PLC's experimental immunotherapy medicine Imfinzi improved progression-free survival by more than 11 months in patients with nonresectable non-small-cell-lung cancer, compared to the standard treatment option, according to highly anticipated late stage data from the Pacific trial presented at the European Society for Medical Oncology, or ESMO, 2017 Congress.
The Pacific study, one of the most closely watched by analysts, investors and oncologists at the gathering of cancer experts in Madrid, showed that Imfinzi is the first medicine to extend life without the disease worsening in this indication. In addition, patients receiving Imfinzi had a lower chance of the cancer spreading than those on placebo. Headline results from the Pacific trial were previously announced by AstraZeneca but this is first time the full data set was revealed.
"The phase 3 Pacific trial results are incredibly encouraging for a patient population that until now has been without treatment options," said Sean Bohen, AstraZeneca's chief medical officer and executive vice president of global medicines development. "As the first immuno-oncology medicine to achieve improvement in progression-free survival in this setting, Imfinzi is showing clear potential to become the new standard of care for patients with locally-advanced, unresectable NSCLC who have not progressed following chemoradiation."
Among the side effects experienced by patients on the medicine, cough and pneumonitis were the most common see in the trial, which continues to evaluate overall survival as another primary endpoint.
Imfinzi received a breakthrough therapy designation from the U.S. Food and Drug Administration on July 31 for use in this indication and has received accelerated approval for previously treated patients with advanced bladder cancer. AstraZeneca said it is in discussions with global regulatory authorities about submitting this latest data from the Pacific trial and will update investors at its quarterly results.
"Pacific has the potential to open up a unique setting for Imfinzi where other PD-1/L1 inhibitors are much further behind in development, and is particularly important for AstraZeneca in the wake of Mystic's failure to show a progression-free survival for Imfinzi plus tremelimumab in the first line metastatic setting," said Leerink's Seamus Fernandez in a note ahead of the data's publication.
ESMO has brought some 23,000 cancer experts together to hear about the latest pioneering research.
"The key things are the two studies from AstraZeneca on Imfinzi and Tagrisso," said Richard Parkes from Deutsche Bank in an interview ahead of the meeting. "They're the only thing share price moving and even then we know the headline figures already."