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AZ buoyed by latest lung cancer data at ESMO

Data from separate Tagrisso and Imfinzi trials show superior PFS among patients

ESMO

A pair of positive trials for AstraZeneca's new lung cancer drugs Imfinzi and Tagrisso is helping the company to a healthy share price rise this morning.

Reported at the European Society of Medical Oncology (ESMO) conference in Madrid, the PACIFIC trial showed a spectacular improvement in progression-free survival (PFS) with PD-L1 inhibitor Imfinzi (durvalumab) as a maintenance therapy in patients with non-small cell lung cancer, while EGFR blocker Tagrisso (osimertinib) outperformed two older drugs in NSCLC in the FLAURA study.

The results will go a long way to buoy confidence in its cancer portfolio, which took a knock in July when Imfinzi failed to hit the mark in first-line NSCLC in the MYSTIC trial.

The overall findings from PACIFIC were reported in May, but oncologists had the opportunity to see just how big an advantage Imfinzi conferred at ESMO. Patients with advanced, inoperable and chemotherapy-resistant NSCLC - who had not progressed after first-line chemotherapy and radiotherapy - gained an extra 11 months of PFS compared to placebo. Patients on AZ's drug had a PFS of 16.8 months, compared to 5.6 months in the control group.

The benefits were seen across all patient subgroups, regardless of PD-L1 status, and AZ's drug was also associated with a lower incidence of metastases. It's the first among the immune-oncology cancer drugs to show a benefit in this indication and analysts at Deutsche Bank said earlier this year that a maintenance indication could add $1.75bn to $3.5bn in potential sales for the drug.

Much of that could be captured by AZ, at least initially, as rival PD-1/PD-L1 inhibitors are thought to be at least two years behind AZ's drug in development. The drug maker is optimistic that it will be able to file for approval based on the PACIFIC data alone, and with a breakthrough designation already in hand from the FDA, it could be pitching at a potential approval in the first half of 2018.

Lead PACIFIC investigator Luis Paz-Ares of the Hospital Universitario Doce de Octubre, Madrid, Spain, said that the data "offers hope to increase the cure rate in this setting", but added that additional follow-up is needed to assess its impact on survival.

AZ was awarded accelerated approval by the FDA for Imfinzi in previously-treated patients with advanced bladder cancer in May, pulling in just $1m in sales in the first half according to AZ's results announcement.

The FLAURA trial showed equally impressive results for Tagrisso, with the drug achieving an ‘unprecedented’ PFS of 18.9 months as a first-line therapy for EGFR-positive NSCLC patients, compared to just over 10 months for first-generation EGFR-targeting drugs, Roche's Tarceva (erlotinib) and AZ's own Iressa (gefitinib). Added to that, Tagrisso also seemed to have fewer side effects than the comparator drugs.

The results suggest Tagrisso could become the dominant drug for first-line EGFR-positive NSCLC patients, extending its current indications for second-line use and injecting even more momentum into a product that saw its sales almost triple to $403m in the first half of the year.

Suresh Ramalingam of Emory University in Atlanta, USA, who led the trial, said the data are "likely to result in a major paradigm shift in the treatment of patients with EGFR mutation-positive advanced lung cancer".

Sean Bohen, AZ's chief medical officer, was also upbeat about the FLAURA data, describing it as "truly exciting".

"Until now, even with the therapeutic advances offered by the first- and second-generation EGFR inhibitors, less than 20% of EGFR mutation-positive NSCLC patients survive for five years."

Article by
Phil Taylor

11th September 2017

From: Research

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