AstraZeneca upbeat on lung cancer drug test findings
AstraZeneca reported recent trial findings for two of its lung cancer drug candidates on Monday, claiming both Imfinzi and Tagrisso had shown positive effects in the PACIFIC and FLAURA trials.
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The FTSE 100 drugmaker and its global biologics research and development arm MedImmune presented the full progression-free survival data from a planned interim analysis of the Phase III PACIFIC trial, investigating Imfinzi (durvalumab).
It said the results showed that Imfinzi demonstrated a “statistically-significant and clinically-meaningful” improvement in progression-free survival compared to the current standard of care, with active surveillance in patients with locally-advanced stage III, unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy/
Results of the Phase III PACIFIC trial, included at the Presidential Symposium I of the European Society of Medical Oncology 2017 Congress in Madrid, Spain, showed an improvement in progression-free survival of more than 11 months in patients treated with Imfinzi, compared to placebo.
AstraZeneca said the progression-free survival improvement with Imfinzi was observed across all prespecified subgroups, including PD-L1 expression status.
Patients receiving Imfinzi also had a lower incidence of metastases than those receiving placebo.
The PACIFIC trial continued to evaluate overall survival, the other primary endpoint, AstraZeneca explained.
“The Phase III PACIFIC results are incredibly encouraging for a patient population that until now has been without treatment options,” said AstraZeneca’s executive vice president for global medicines development Sean Bohen.
“As the first immuno-oncology medicine to achieve improvement in progression-free survival in this setting, Imfinzi is showing clear potential to become a new standard of care for patients with locally-advanced, unresectable NSCLC who have not progressed following chemoradiation.”
Dr Luis Paz-Ares, principal investigator of the PACIFIC trial from the Hospital Universitario Doce de Octubre in Madrid, said that for patients with locally-advanced unresectable NSCLC who have completed chemoradiation therapy, Imfinzi represented a potential new treatment option in the context of “clear unmet clinical need”.
“Durvalumab overtly prolongs the period in which the disease is controlled with reasonable side effects.
“In addition, it offers hope to increase the cure rate in this setting, but more mature follow-up is needed to assess its impact on survival.”
In its second announcement, AstraZeneca presented the full results of the Phase III FLAURA trial, which it said supported the potential of Tagrisso (osimertinib) as a new standard of care in the first-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer (NSCLC).
The company said the results of the Phase III FLAURA trial, also included at the Presidential Symposium I in Madrid, and demonstrated a “superior, clinically-meaningful” progression-free survival advantage with Tagrisso compared with the current treatments, erlotinib or gefitinib.
“The FLAURA data are truly exciting,” said Sean Bohen.
“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.
“The FLAURA data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains.”
Dr Suresh S Ramalingam, principal investigator of the FLAURA trial from the Winship Cancer Institute of Emory University in Atlanta, said the FLAURA data for osimertinib were likely to result in a “major paradigm shift” in the treatment of patients with EGFR mutation-positive advanced lung cancer.
“Not only did the trial demonstrate a robust improvement in efficacy with osimertinib when compared to other commonly-used EGFR inhibitors, the side effects profile was also more favourable with osimertinib.”