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(Alliance News) - AstraZeneca PLC on Monday said it received a host of approvals or recommendations for approval for a handful of prospective treatments in the EU, but noted disappointing phase 3 trial results for Imfinzi.
The Cambridge, England-based pharmaceutical company said its Enhertu treatment with Daiichi Sankyo Co Ltd was approved for previously-treated HER2-positive advanced gastric cancer patients in the EU, while it was recommended for approval for metastatic breast cancer patients.
AstraZeneca said it marked the first HER2-directed antibody drug conjugate medicine to be approved for gastric cancer in the EU in more than a decade.
The approval by the European Commission was based on Destinyt-Gastric01 and Destiny-Gastric02 phase 2 trials, which found Enhertu demonstrated a clinically meaningful efficacy in adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Approximately 136,000 cases of gastric cancer are diagnosed annually in Europe, where it represents the sixth leading cause of cancer death. Gastric cancer is typically diagnosed in the advanced stage, while around one in five gastric cancers are HER2-positive.
"With this approval, we can now offer patients with previously treated HER2-positive gastric cancer a treatment with clinically meaningful efficacy," said Daiichi Chief Executive Officer Ken Keller.
Meanwhile, Enhertu was also recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use for patients with HER2-low metastatic breast cancer.
AstraZeneca said the CHMP based its positive opinion on results from the Destiny-Breast04 phase 3 trial, recommending the monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer.
This is specifically for patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
"Enhertu is the first-ever HER2-directed medicine to show a survival benefit in patients with HER2-low metastatic breast cancer, confirming the importance of targeting lower levels of HER2 expression in patients previously classified as HER2-negative. The CHMP's recommendation is encouraging and supports our ambition to evolve the way breast cancer is classified and treated to ultimately improve patient outcomes," said Susan Galbraith, executive vice president in oncology research & development at AstraZeneca.
The CHMP also recommended AstraZeneca's Forxiga treatment for approval for patients with symptomatic chronic heart failure.
If approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction range with proven mortality reduction.
The approval recommendation was based on results from the Deliver phase 3 trial, published in the New England Journal of Medicine, and pooled analysis of the DAPA-HF and Deliver phase 3 trials published in the Nature Medicine journal.
Chronic heart failure affects around 15 million people in the EU. Patients suffer from a wider range of symptoms, physical limitations and poor quality life.
"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. As a leader in cardiorenal disease, AstraZeneca is committed to expanding heart failure treatment options, changing the way we treat this complex disease to improve patient outcomes," said Mene Pangalos, executive vice-president in biopharmaceuticals research & development at AstraZeneca.
The CHMP also recommended EU approvals for AstraZeneca's Imfinzi and Imjudo combination treatments for advanced liver and lung cancers.
Both treatments are designed to be conducted in combination for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma, alongside with platinum-based chemotherapy for the treatment of adult patients with stage four metastatic non-small cell lung cancer.
The approval recommendations were made following results from the Himalaya phase 3 trial and the Poseidon phase 3 trial.
"Patients in Europe diagnosed with these advanced cancers urgently need treatment combinations that can help them live longer. If approved, these Imjudo and Imfinzi combinations will provide patients with novel options that harness the potential long-term survival benefits seen with cytotoxic T-lymphocyte-associated protein 4 inhibition," said Galbraith.
AstraZeneca also provided an update on its Pearl phase 3 trial of Imfinzi in stage 4 NSCLC patients, which did not achieve statistical significance for the primary endpoints of improving overall survival versus the platinum-based chemotherapy as a monotherapy treatment.
The safety and tolerability profile for Imfinzi was broadly consistent with the known profile of the medicine, while no new safety signals were identified.
Shares in AstraZeneca were down 0.5% at 11,096.00 pence each in London on Monday morning. Daiichi Sankyo shares closed down 1.8% at JPY4,437.00 in Tokyo.
By Greg Rosenvinge, Alliance News reporter
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