AstraZeneca PLC (LSE:AZN) shares slipped back on Monday as it reported mixed results from the latest trial (PEARL) of its cancer drug Imfinzi.
Using the drug as a single therapy for lung cancer sufferers, Imfinzi missed its primary endpoint of improving survival rates among patients with stage IV metastatic disease and showing high levels (25%) of the biomarker PD-L1.
Patients who potentially might respond well to immunotherapy can be indicated by PD-L1 and for those with 50% or more of the marker in their cells, Imfinzi did improve survival rates, which was its secondary endpoint said AstraZeneca.
In a statement, Susan Galbraith, AstraZeneca’s Oncology R&D executive vice president, commented: "With PEARL, we set out to answer important scientific questions in the treatment of metastatic non-small cell lung cancer at a time when patient selection for immune checkpoint inhibitors was still evolving.
“We are encouraged to see patients in the metastatic setting at a higher level of PD-L1 tumour expression demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen in this class.”
Separately, AstraZeneca announced that it had received regulatory approval for its Enhertu cancer drug from the EU for use as a monotherapy in metastatic HER2 breast cancer patients and for HER-2 gastric cancer patients.
The pharma said it is the first medicine for this type of gastric cancer to be approved in Europe for more than a decade.
Elsewhere, AstraZeneca added that European regulators (CHMP) had recommended approval for a combination of Imfinzi and another drug Imjudo as a combination to treat advanced liver and lung cancers.
CHMP also recommended a broader application for heart failure therapy Forxiga be approved.
Mene Pangalos, Astra’s executive vice president, biopharmaceuticals R&D, said: "Forxiga has already transformed the standard of care for millions of people in the EU living with heart failure. If approved for this new, broader indication for heart failure with mildly reduced or preserved ejection fraction, more patients will be able to benefit from this well-tolerated and guideline-directed treatment.”
Shares in AstraZeneca eased 0.7% lower to 11,082p in early trading.