AstraZeneca plc (NYSE: AZN) shares were advancing Monday following a clinical readout from the company.
The U.K.-based pharma giant said its Phase 3 POSEIDON trial produced positive results.
The study is evaluating AstraZeneca’s Imfinzi — an anti-PD-L1 human monoclonal antibody — in combination with tremelimumab, an anti-CTLA antibody, along with chemotherapy for previously untreated Stage IV non-small cell lung cancer, or NSCLC.
The late-stage study met the primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Imfinzi and a broad choice of five standard-of-care platinum-based chemotherapy options vs. chemotherapy alone, the company said.
The triple combo of Imfinzi, tremelimumab and chemotherapy also met the key secondary endpoint of showing a statistically significant and clinically meaningful PFS improvement vs. chemotherapy alone, AstraZeneca said in a statement.
On the safety front, the company said the triple combo option had a similar safety profile as that of the Imfinzi-and-chemo combo and did not lead to increased discontinuation of therapy.
Why It’s Important
Lung cancer is the leading cause of cancer deaths, accounting for about one-fifth of the total, according to AstraZeneca. NSCLC accounts for about 70-75% of all lung cancers.
Imfinzi has already been approved for unresectable Stage 3 NSCLC.
“Clinical benefit was observed in a trial population that included a high proportion of patients with squamous disease and multiple choices of chemotherapy regimens,” Jose Baselga, the executive vice president of oncology R&D at the drugmaker, said in a statement.
“Additionally, the potential to add tremelimumab to Imfinzi and chemotherapy may present an important treatment approach in this challenging setting, especially taking into consideration the favorable safety profile.”
The POSEIDON study will continue to assess the additional primary endpoint of overall survival, with data anticipated in 2020, according to AstraZeneca.
The company said it will submit the results for presentation at a forthcoming medical meeting and plans to share the results with health authorities.
The stock was trading 0.36% higher at $47.85 at the time of publication.
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